Patricia Crosbie, Partner in Malcomson Law Solicitors, discusses the drug Seroxat. She advises how the rate of congenital heart defects in babies/children is higher in women taking Seroxat and on a recent Judgment in relation to a 3 year old boy where the family has been awarded $2.5 Million.
Read the files from the court case HERE
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label GSK - Brushed Under The Carpet. Show all posts
Showing posts with label GSK - Brushed Under The Carpet. Show all posts
Wednesday, October 28, 2009
Friday, October 23, 2009
GlaxoSmithKline - Quite a Tainted History [In Video]
I first dabbled with making videos for youtube a while back - one caused a bit of controversy, so much so that Glaxo lawyers complained - see Pharmalot, one of many websites that picked up on the story at the time.
Recently I set out to make another video that featured newspaper stories regarding GlaxoSmithKline and their somewhat tainted history. To my surprise I couldn't find an accompanying song quite long enough so had to make three videos.
It astounds me that such a company as GlaxoSmithKline with so much bad press is still in operation. No prosecutions, as far as I am aware, have ever taken place. After watching all three videos you may ask the same question that I have been asking myself - Why?
The song is Motorhead's, 'Just Cos You Got the Power'... [That Don't Mean You Got the Right] - lyrics beneath the videos.
How Powerful are GlaxoSmithKline? Part I
How Powerful are GlaxoSmithKline? Part II
How Powerful are GlaxoSmithKline? Part III
You might be a financial wizard,
With a sack of loot,
But all I see is a slimy lizard,
With an expensive suit,
Go on and run your corporation,
Go on and kiss some ass,
You can buy half of the nation,
But you can't buy class
You bastards think it's funny,
Lyin' and thieving all your life,
Think all there is is money,
Got your future wrapped up tight,
But Just 'Cos You Got The Power,
That don't mean you got the right
You can take my fingers buddy,
You can take my eyes,
You can take my past and future,
They won't make you wise,
You can have me thrown in jail,
You can steal my booze,
You can even steal my mail,
Step on my blue suede shoes,
You bastards might be clever,
Got it mapped out in black and white,
But remember you can't ever,
Teach a dog to stand up-right,
And Just 'Cos You Got The Power,
That don't mean you got the right
And Just Cos' You Got The Power,
That don't mean you got the right,
Oh no, oh no, shoot me down
Go on out make another deal,
Feed your big fat face,
Go on out and cop a feel,
Get on somebody's case,
You surely could be satisfied,
If you could get it all,
But time ain't on your side,
You're going to the wall
You think that life's just dollars,
On with greed and lust and spite,
But I wasn't born to follow,
Like to get my sleep at night,
I surely do,
Just 'Cos You Got The Power,
That don't mean you got the right,
Just Cos' You Got The Power,
That don't men you got the right,
Just Cos' You Got The Power,
That don't mean you got the right.
Würzel, Campbell, Lemmy, Taylor
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Recently I set out to make another video that featured newspaper stories regarding GlaxoSmithKline and their somewhat tainted history. To my surprise I couldn't find an accompanying song quite long enough so had to make three videos.
It astounds me that such a company as GlaxoSmithKline with so much bad press is still in operation. No prosecutions, as far as I am aware, have ever taken place. After watching all three videos you may ask the same question that I have been asking myself - Why?
The song is Motorhead's, 'Just Cos You Got the Power'... [That Don't Mean You Got the Right] - lyrics beneath the videos.
How Powerful are GlaxoSmithKline? Part I
How Powerful are GlaxoSmithKline? Part II
How Powerful are GlaxoSmithKline? Part III
You might be a financial wizard,
With a sack of loot,
But all I see is a slimy lizard,
With an expensive suit,
Go on and run your corporation,
Go on and kiss some ass,
You can buy half of the nation,
But you can't buy class
You bastards think it's funny,
Lyin' and thieving all your life,
Think all there is is money,
Got your future wrapped up tight,
But Just 'Cos You Got The Power,
That don't mean you got the right
You can take my fingers buddy,
You can take my eyes,
You can take my past and future,
They won't make you wise,
You can have me thrown in jail,
You can steal my booze,
You can even steal my mail,
Step on my blue suede shoes,
You bastards might be clever,
Got it mapped out in black and white,
But remember you can't ever,
Teach a dog to stand up-right,
And Just 'Cos You Got The Power,
That don't mean you got the right
And Just Cos' You Got The Power,
That don't mean you got the right,
Oh no, oh no, shoot me down
Go on out make another deal,
Feed your big fat face,
Go on out and cop a feel,
Get on somebody's case,
You surely could be satisfied,
If you could get it all,
But time ain't on your side,
You're going to the wall
You think that life's just dollars,
On with greed and lust and spite,
But I wasn't born to follow,
Like to get my sleep at night,
I surely do,
Just 'Cos You Got The Power,
That don't mean you got the right,
Just Cos' You Got The Power,
That don't men you got the right,
Just Cos' You Got The Power,
That don't mean you got the right.
Würzel, Campbell, Lemmy, Taylor
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Thursday, October 22, 2009
Wednesday, September 30, 2009
Cervarix Vaccine: " Unlikely Cause of Death"
Well, it would appear that GlaxoSmithKline's Cervarix vaccine was not the cause of 14 year old Natalie Morton's death, at least that are the reports coming from the mainstream media. It's all very confusing - one minute Coventry health officials are suspending the immunisation programme, the next they are announcing that they are not? Even more strange are the reports that the programme has been halted in other parts of the UK such as Knowsley, Halton and St Helens [Liverpool Daily Post] - Also, the Wales Online website claims that the batch used to immunise Natalie Morton and her school friends had been withdrawn from use in Wales?
A press release from the Medicines Healthcare and products Regulatory Agency [MHRA] states that the HPV Vaccine batch has been recalled while investigation underway. [Link] MHRA Chief Executive, Professor Kent Woods, said the risk/benefit profile for Cervarix remains positive and that the safety and efficacy of the vaccine had been extensively researched in clinical trials before licensing. All this without the results of Natalie Morton's autopsy? All we have, from the mainstream media thus far is that Natalie had an 'underlying health problem' and that the Cervarix was the 'unlikely cause of her death'. Unless of course the MHRA have privy information regarding Natalie's health?
It all seems rather strange to me that a decision of whether or not a vaccine is safe has been made overnight when there is no information on exactly what the 'underlying health problem' was.
Professor Woods has also gone on record claiming, "...many women’s lives will be saved in the future as a direct result of this vaccine." I'd like a peek inside Professor Woods crystal ball or would like to see the data that he has seen that shows that 20 years from now women who had this vaccine have benefited from it. Professor Woods should not make these claims because the long term benefit of Cervarix has not been proven yet - unless there has been some mysterious clinical trial from the late 1980's?
I'm not having a 'pop' at the MHRA CEO, I've met him, he's a fairly decent chap but I do wish he would think before making such rash statements regarding a vaccine that has not had 20 or so years of clinical study.
Then we have a case that has pretty much slipped off the radar regarding Cervarix and another school girl. Paige Brennan was immunised with Cervarix in March. Six months on, the 13-year-old is still unable to talk or walk properly after falling ill with a virus following her jab. But hey, that's okay because "...many women’s lives will be saved in the future as a direct result of this vaccine."
The Mirror writes, Mum Margaret, 40, who visits Paige every day at Birmingham Children's Hospital, is adamant she won't allow younger daughter Chloe to have it when the time comes.
Margaret said: "Since Paige's illness I have researched so many similar cases of girls whose nervous systems have been mysteriously struck down in the same way.
"It's tragic that it takes the death of a teenager to make someone sit up and listen. For all we know we could be harming a whole generation of teenage girls."
The UK government should also take some responsibility here. They, it appears, were given a choice of vaccine, Merck's Gardasil or GSK's Cervarix. They opted for Cervarix. It's a classic case of two products being identical, let's say for example two George Michael CD's in your local record store, one for sale at £12, the other in the 'Bargain Bin' at £8. We'd all jump at the chance of buying the cheaper CD would we not? Vaccines are different and no price should be put on the well-being of our children. Gardasil and Cervarix are the same aren't they, or am I wrong? Does Gardasil have a bonus track on? Damn, I should have looked more carefully at the George Michael discs!
Can we expect an impartiality from the UK government? Well, look at Prime Minister Gordon Brown's National Business Council and you see that one of its advisor's is none other than Andrew Witty, chief executive of drug developer GlaxoSmithKline PLC. Previously Gordon Brown had recruited Jean-Paul Garnier, the then GlaxoSmithKline chief, to serve on the Business Council.
A young girl has died and whether or not Cervarix was the cause of Natalie Morton's death, it should not take this to bring the Cervarix immunisation programme up for debate. We certainly don't need the Chief Executive of the UK Medicines Regulator promoting future sales of the vaccine!
There seems to be a break neck speed race to have children vaccinated with Cervarix, it's almost as if there is a huge crisis of cervical cancer in women. In truth there isn't. In 2005, 911 women died of the disease, yes it's a high figure but when you run it past other figures you will see it pales next to the 12,000 who died from lung cancer or the 11,000 who succumbed to breast cancer. Cervical cancer comes in 19th place on the list of cancers that kill women in modern Britain.
It will be 20 years before we know whether Cervarix is effective in preventing cervical cancer. Unless of course you are privy to take a peek inside the MHRA's crystal ball.
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Tuesday, September 29, 2009
US Cervarix delay deals blow to GlaxoSmithKline
US regulators have delayed their decision on whether to approve GlaxoSmithKline's cervical cancer vaccine Cervarix, writes the Daily Mail.
They add, "The ruling from the powerful US Food and Drug Administration had been expected yesterday but instead the body announced it needed more time to consider the application.
The FDA's renewed caution came just a day after the death of 14-year- old Coventry girl Natalie Morton who had been vaccinated with Cervarix."
FULL STORY HERE
Related links:
Cervarix Tested For Boys!
GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed
4,602 Suspected Adverse Reactions to GSK's Cervarix!
Girls used as Guinea Pigs in HPV Trials Admits GSK
GSK - A Catalogue of Disasters!
Glaxo: "Promote More, Feel Better and Live a Life of Luxury"
Glaxo Goes Head-to-Head on HPV
Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!
GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine
HPV Vaccine Video on Youtube
Concerns over GSK's Cervarix vaccine
UP YOURS GLAXO!
Mindy Merck & Gail Glaxo Dilemma
LOLA'S LAND PROMOTING HPV VACCINE
GlaxoSmithKline's Cervarix. Is Your Daughter Safe?
More debate on GSK's Cervarix
Cervical Cancer, Ofsted & GlaxoSmithKline
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
GLAXO RECALL CERVARIX VACCINE
News just in from the MHRA web page. Glaxo have have ordered a recall of Cervarix... but only one batch?
Judging by the letter, issued by Alison Bunce, Pharmaceutical Assessor, DMRC, it would appear that the investigation into the death of Natalie Morton [I prefer to give this child a name] has already concluded! The last line reads: "Further stocks of vaccine from different batches can be ordered in the usual way."
It would appear that their minds have already been made up whether or not Cervarix was the cause of Natalie Morton's death.
Dear Healthcare Professional,
GlaxoSmithKline Biologicals sa
Cervarix suspension for injection in prefilled syringes
Human papillomavirus vaccine
Eu/1/07/419/004
Batch number - AHPVA043BB
Expiry date - 09/2010
Pack size - 1 Syringe + needle
First distributed - 1 May 2009
Following the tragic death of a young girl, who had received vaccination from the above batch of Cervarix, the Department of Health has issued a quarantine notification.
As a further precautionary measure, GlaxoSmithKline Biologicals sa is now undertaking a voluntary recall of the above batch of Cervarix pending further investigation.
Please quarantine any remaining stocks of this batch. Movianto UK Ltd will contact customers directly regarding stock and the details of the product to be collected. Movianto can be contacted by email (customercare.uk@movianto.co.uk)
The benefit risk assessment for the vaccine remains unchanged; there is currently no proven link between vaccination and the event and the HPV vaccination programme will continue.
No other batches are affected by this recall. Further stocks of vaccine from different batches can be ordered in the usual way.
Recall Announcement HERE
Fid
Related articles:
Cervarix tested for Boys!
Natalie Morton, 14 Dies after Cervarix jab
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Cervarix tested for Boys!
It would appear that my Blackheath cyberstalker, Mardi Bennett, is now accusing this blog of scaremongering regarding the Cervarix issue.
She writes on the UK Survivor's Forum:
"If you're so concerned about this issue and want to raise awareness – wouldn't it make more sense to put links to relevant factual research, pharmacological information (including chemical ingredients) and medically based articles and websites here - so active members and those lurking and reading, could make informed choices - instead just posting flippant scaremongering statements, sensationalizing and quoting "facts" out of context and directing people to your website.
People could get the impression that you think your point of view, your blog (where "fact" and fiction are interwoven to express your opinion), condemning GSK and your viewer hit ratings are far more important that the actual issue!"
Well, I don't know exactly what Ms Bennett wants from me, she has, in the past, accused me of only being concerned about the dangers of Seroxat, despite my meeting with the MHRA where I raised concerns about ALL SSRi's.
For the benefit of Ms Bennett, I will point her and other readers of this blog to some interesting 'facts' regarding GlaxoSmithKline's Cervarix.
It is well-known that Merck's Gardasil is a rival vaccine to GSK's Cervarix. Those of you who have kept an eye on these vaccines will already know that an FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts. [1]
Gardasil also contains Sodium Borate [2], also known as Borax. It has many common uses. In addition to its use as a rat poison, it is also used in laundry detergents and cosmetics.
Moving on to GSK's Cervarix. Rather than post the links where I have wrote about this before I will just refer you to one post that contains all the relevant links at the bottom [3]
What readers of this blog may not know is that, like Gardasil, GSK's Cervarix was part of a study to evaluate the immunogenicity and safety of the vaccine in males.
The study appeared in the Journal of Adolescent Health and was received 8 July 2008, accepted 6 October 2008 and made available online 21 December 2008.
Two members of this study, namely, Olivier Godeaux M.D and Gary Dubin M.D work for GlaxoSmithKline Biologicals, Rixensart, Belgium and GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania respectively.
The study contains all the relevant information that Mardi Bennett requires [4]
May I suggest that Ms Bennett spend her time researching facts rather than write endless emails to the Medicines Healthcare and products Regulatory Agency [MHRA] about me and the work I do related to this blog. [5]
Here endeth the first lesson in 'factual evidence'
Fid
[1] FDA Panel OKs HPV Vaccine Gardasil for Boys
[2] Gardasil Patient Information Leaflet
[3] Schoolgirl, 14, dies and three classmates taken ill after being given GSK's cervical cancer vaccine. [Scroll to bottom for other links]
[4] Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years.
[5] Stalkers Request Information from MHRA and Blogger On Paxil's Dangers Draws Weird Attention.
Update: Coventry's cervical cancer vaccination programme has been suspended following the sudden death of a 14-year-old girl who had received the HPV1 Cervarix jab.
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Monday, September 28, 2009
Schoolgirl, 14, dies and three classmates taken ill after being given GSK's cervical cancer vaccine
Source Daily Mail
A 14-year-old schoolgirl today died shortly after being given the new cervical cancer vaccine.
The teenager collapsed at her school in Coventry after receiving the jab as part of a national immunisation programme.
She was taken to hospital but doctors were unable to save her.
Three of her classmates also suffered possible side-effects after being injected with Cervavix, which protects against human papillomavirus (HPV), this afternoon.
Read more
----
I've banged the drum about GSK's Cervarix before. Quite why this mass immunisation is going on baffles me. Stop this before the problem escalates - which I'm sure it will years down the line - just as it has done with other GSK drugs!
Links below - Includes the wanton promotion of this particular vaccine on a UK children's website!
GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed
4,602 Suspected Adverse Reactions to GSK's Cervarix!
Girls used as Guinea Pigs in HPV Trials Admits GSK
GSK - A Catalogue of Disasters!
Glaxo: "Promote More, Feel Better and Live a Life of Luxury"
Glaxo Goes Head-to-Head on HPV
Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!
GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine
HPV Vaccine Video on Youtube
Concerns over GSK's Cervarix vaccine
UP YOURS GLAXO!
Mindy Merck & Gail Glaxo Dilemma
LOLA'S LAND PROMOTING HPV VACCINE
GlaxoSmithKline's Cervarix. Is Your Daughter Safe?
More debate on GSK's Cervarix
Cervical Cancer, Ofsted & GlaxoSmithKline
Is Cervarix and Gardasil Safe ? Humorous and very blunt answer.
Fid
SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me
*GSK INTERNAL FILES BLOG
JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Sunday, September 13, 2009
4,602 Suspected Adverse Reactions to GSK's Cervarix!
Benefits outweigh the risks?
Firstly, the benefits are unknown, it's based on assumptions.
The risks? - Well, read yesterday's Daily Telegraph.
Doctors' reports show that girls of 12 and 13 have experienced convulsions, fever and paralysis after being given the vaccine, which is now administered in schools as part of efforts to prevent women developing cancer.
Others suffered nausea, muscle weakness, dizziness and blurred vision, according to a special report drawn up by drug safety watchdogs.
A support group says it has received dozens of calls from parents who believe their daughters have been damaged by the vaccine.
The parents of one teenage girl given the jab last autumn believe it was to blame for repeated seizures which have left her with brain damage and psychosis.
The immunisation programme for teenage girls is controversial because it protects them from the sexually transmitted human papillomavirus which causes 70 per cent of cervical tumours.
When the Government introduced the Cervarix vaccination programme last year, some campaigners dubbed it a "promiscuity jab".
Continue reading HERE
**Footnote - FDA backs Glaxo's vaccine Cervarix for women
Related stories from Seroxat Sufferers Blog:
Girls used as Guinea Pigs in HPV Trials Admits GSK
GSK - A Catalogue of Disasters!
Glaxo: "Promote More, Feel Better and Live a Life of Luxury"
Glaxo Goes Head-to-Head on HPV
Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!
GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine
HPV Vaccine Video on Youtube
Concerns over GSK's Cervarix vaccine
UP YOURS GLAXO!
Mindy Merck & Gail Glaxo Dilemma
LOLA'S LAND PROMOTING HPV VACCINE
GlaxoSmithKline's Cervarix. Is Your Daughter Safe?
More debate on GSK's Cervarix
Cervical Cancer, Ofsted & GlaxoSmithKline
Is Cervarix and Gardasil Safe ? Humorous and very blunt answer.
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Thursday, August 20, 2009
The Caspper Files [GSK's Ghostwriting Machine]
So, what exactly is CASPPER?
CASPPER stands for, Case Study Publications For Peer Review.
The fact that the name is synonymous with a ghost [Casper] is probably just down to high jinks from the Glaxo [SmithKline Beecham] team. It could also be high jinks that the name 'Paxil' could possibly be named after a toxic fungi [Paxillus involutus] although that is just supposition on my part.
Okay, let's dissect Caspper.
The Paxil Product Management launched Caspper, an apparent innovative program that was intended, it appears, to bring to the attention of 'important psychiatrists' by
**Offering assistance in the preparation and publication of case studies and other short communications relevant to the features and benefits of PAXIL.
** Encouraging the timely publication of responses to unbalanced information from competitors.
It appears the goal of Caspper was to benefit the salesforce by expanding the database of published data to support PAXIL. Furthermore, Caspper was also intended to strengthen relationships between the salesforce team [Reps] and 'key physicians and thought leaders in the psychiatric field.'
The objectives of Caspper were to 'strengthen the product positioning and overcome competitive issues.'
Some of the target areas for topic were:
**Anxiety disorders [eg; panic disorder, social anxiety disorder, and Obsessive Compulsive Disorder [OCD]
**Long term use of Paxil
**Use in the elderly
**SSRi use in women
** Successful management of sexual dysfunction
Quite ironic that they should target these particular topics. Long term use of Paxil has always been a grey area, in fact I don't even think GlaxoSmithKline have any answers to what damage prolonged use of Paxil can cause those taking it... if they do, then they are hiding it well.
Use in the elderly - hasn't there been studies that show vulnerability in children and the elderly taking Paxil?
SSRi use in women - Funny they should target this particular area. Here is a snippet from Dr. David Healy's withdrawal protocol JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY
"One of the biggest problems of SSRI dependence involves women who are on treatment and unable to stop who wish to become pregnant. Getting off an SSRI at present seems more difficult for women than men, even with the incentive of wishing to become pregnant."
Wasn't Healy the same man GSK targetted many years ago when he first spoke out against SSRi's?
I seem to recall Dr. Alastair Benbow, Head of European Psychiatry for Glaxosmithkline, claim that "Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac, he made the same claims about Prozac, he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong."
I think it is safe to assume now that Healy was right all along don't you Dr. Benbow?
Caspper continues to explain to the salesforce team that they should encourage physicians to author a paper regarding the benefits of Paxil. With the help of Caspper, it seems, writing a paper was never easier! In fact, Caspper seemed to do everything for the physician:
The full range of editorial assistance that CASPPER can offer contributing physicians is:
**Developing a topic
**Coordinating the editorial review process
**Submitting to the target journal
It even went as far as:
**Copy editing and proofreading
**Production of tables and graphics
** Preparation of the submission package
**Follow-up
It seems from this document that the aim was to more or less let Glaxo take control. [GHOSTWRITER]
The closing remarks of the 14 page document sums it all up.
"PAXIL Product Management has budgeted for 50 articles for 2000. Your participation in CASPPER will enable your physicians to add to the literature supporting the use of PAXIL, strengthen your relationships with key physicians and thought leaders in the psychiatric field, and ultimately, help you meet your sales goals."
The document is now hosted online.
Please disseminate.
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Possible Caspper Articles
McHenry - Industry-Sponsored Ghostwriting in Clinical Trial Reporting- A Case Study
On the Origin of Great Ideas Science in the Age of Big Pharma
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Glaxo used ghostwriting program to promote Paxil
Hat-Tip - Ruth
Source: - Associated Press
Glaxo used ghostwriting program to promote Paxil
By MATTHEW PERRONE (AP)
WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."
The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.
A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.
"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.
According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."
At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.
Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.
But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.
According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.
"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."
McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.
Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.
Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.
Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.
Copyright © 2009 The Associated Press. All rights reserved.
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Source: - Associated Press
Glaxo used ghostwriting program to promote Paxil
By MATTHEW PERRONE (AP)
WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."
The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.
A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.
"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.
According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."
At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.
Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.
But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.
According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.
"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."
McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.
Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.
Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.
Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.
Copyright © 2009 The Associated Press. All rights reserved.
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Fid
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Thursday, July 30, 2009
Popular Breast Cancer Drug Used with Seroxat & Other SSRi's Puts Women At Risk
Source Newswire
A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence.
In May, Medco Health Solutions, Inc and Indiana University School of Medicine released a study revealing that women using tamoxifen to prevent a recurrence of breast cancer who also use certain selective serotonin reuptake inhibitors (SSRI), for example Prozac(R) (fluoxetine), Paxil/Seroxat(R) (paroxetine) and Zoloft(R) (sertraline), have up to twice the chance of having a recurrence of the disease.
FULL SHOCKING STORY HERE
Fid
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Monday, July 27, 2009
Who Killed Japanese Culture?
I've just finished reading a fascinating article from 2004. It was written by Kathryn Schulz and featured in the New York Times.
Kathryn describes in great detail how pharmaceutical companies targeted Japanese citizens with an angle based on their cultural beliefs rather than science.
Largely before 1999 Japanese citizens were, it seems, oblivious to the world of antidepressants, depression was rarely discussed, due, in part, to the cultural belief system.
Around 1999 pharmaceutical companies and their genius marketing teams used a ploy that only they could get away with. An all out attack that defies belief [at least it would have once, until I started writing about pharma]
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Kathryn describes in great detail how pharmaceutical companies targeted Japanese citizens with an angle based on their cultural beliefs rather than science.
Largely before 1999 Japanese citizens were, it seems, oblivious to the world of antidepressants, depression was rarely discussed, due, in part, to the cultural belief system.
Around 1999 pharmaceutical companies and their genius marketing teams used a ploy that only they could get away with. An all out attack that defies belief [at least it would have once, until I started writing about pharma]
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Saturday, July 25, 2009
Paxil Study 329 All Over Again?
Something has been bugging me about the Paxil NCT00812812 trial currently being run by GlaxoSmithKline in Japan. Enough to keep me awake at night to ponder the 112487 trial Protocol and its content, in particular, the exclusion criteria.
For those of you who don't know, the Paxil NCT00812812 trial, underway at this moment in time, is for children from the age of 7 upwards to 17 - Yes, you read it correct, CHILDREN!
It's hard to fathom out why GSK would be yet again trying to target children with a drug that,
For those of you who don't know, the Paxil NCT00812812 trial, underway at this moment in time, is for children from the age of 7 upwards to 17 - Yes, you read it correct, CHILDREN!
It's hard to fathom out why GSK would be yet again trying to target children with a drug that,
by their own admission, is NOT safe in this particular age group. One can only assume that GSK believe the genetic make-up of Japanese subjects is significantly different to those of the Western population, unless of course they have other reasons for wanting to gain a license for use of Paxil in children?
Just because this is Japan does not mean that we should ignore what GSK's intentions are here. They wish for children to take a drug that is dangerous and harmful - it's safe to assume that isn't it?
The criteria for inclusion into this trial stipulates that the subjects must be between the ages of
Just because this is Japan does not mean that we should ignore what GSK's intentions are here. They wish for children to take a drug that is dangerous and harmful - it's safe to assume that isn't it?
The criteria for inclusion into this trial stipulates that the subjects must be between the ages of
7 to 17 - in other words, Children. It also stipulates that the subjects must have Major Depressive Disorder [MDD]. They measure the level of depression according to the DSM-IV-TR criteria - Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3). To the layman, this means children who have major depression.
The exclusion list for this trial is lengthy to say the least and it would appear that GSK want
The exclusion list for this trial is lengthy to say the least and it would appear that GSK want
the 'best' of a 'bad' bunch.
Exclusion Criteria
run-in period: A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD,
Exclusion Criteria
run-in period: A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD,
OCD, Panic disorder, etc)
Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia )or complication of these diseases.
Patients with a history of a bipolar disorder, or complication of these diseases.
Patients with Attention-Deficit, or Hyperactivity Disorder
Patients with Mental Retardation or Pervasive Development Disorder
Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the
Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia )or complication of these diseases.
Patients with a history of a bipolar disorder, or complication of these diseases.
Patients with Attention-Deficit, or Hyperactivity Disorder
Patients with Mental Retardation or Pervasive Development Disorder
Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the
Screening visit
Patients with past treatment experience with the investigational drug (i.e. paroxetine)
Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
Patients with past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)
Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
Patients who have taken antidepressant medication 1 week prior to screening.
Patients with complicated disease of glaucoma.
Patients with convulsive disorders such as epilepsy or past history of these diseases.
Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or patients with bleeding tendency or hemorrhagic diathesis.
Patients with severe renal and hepatic disorder.
Patients with serious organic disorder in the brain.
Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
Patients with clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)
treatment period: Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or
Patients with past treatment experience with the investigational drug (i.e. paroxetine)
Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
Patients with past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)
Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
Patients who have taken antidepressant medication 1 week prior to screening.
Patients with complicated disease of glaucoma.
Patients with convulsive disorders such as epilepsy or past history of these diseases.
Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or patients with bleeding tendency or hemorrhagic diathesis.
Patients with severe renal and hepatic disorder.
Patients with serious organic disorder in the brain.
Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
Patients with clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)
treatment period: Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or
greater compared to that of Week -2.
Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.
Quite a list, I'm sure you would agree?
Forget the scientific talk, it's aimed to confuse. What one has to do here is read between the
Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.
Quite a list, I'm sure you would agree?
Forget the scientific talk, it's aimed to confuse. What one has to do here is read between the
lines to see exactly what GlaxoSmithKline want from this trial.
The last exclusion listed is quite open-ended wouldn't you agree?
Why list such a vague exclusion after naming all other exclusions?
"Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."
This could mean anything and could possibly mean that any subject that could be detrimental into getting Paxil a license will be removed from the trial. That's my train of thought anyway. Am I right to question the motive behind this vague statement? One only has to study the
The last exclusion listed is quite open-ended wouldn't you agree?
Why list such a vague exclusion after naming all other exclusions?
"Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."
This could mean anything and could possibly mean that any subject that could be detrimental into getting Paxil a license will be removed from the trial. That's my train of thought anyway. Am I right to question the motive behind this vague statement? One only has to study the
Paxil 329 study to see how GSK massaged data to gain a license for children all those years ago. A license that was obtained by fraudulently manipulating figures - something GSK have never been held accountable for... unless a slap on the wrists counts as a punishment?
Does the whole world need to be reminded of the infamous SmithKline Beecham
Does the whole world need to be reminded of the infamous SmithKline Beecham
Paxil 329 study again?
Are they trying to gain a license for Paxil in children in Japan because of the language barrier?
CYP450-2D6 is a phrase some of you may not have heard of before and, I believe, it's one that GSK don't want you to hear about either.
To cut a long story short, anyone who is deficient in the CYP450-2D6 Cytochrome can be at danger if they take Paxil. There is no easier way to say it folks.
This, I believe, bothers GSK with regard to Paxil, so much so that it was announced in March 2006 that GSK had 'solved' the Structure of Human Cytochrome P450 2D6 [1]
The 2D6 deficiency differs from culture to culture. In Asia approx 60% of the Asian population (Thai, Chinese & Japanese) are poorer than normal metabolizers of drugs such as Paxil, which primarily use the 2D6 enzyme.[2] Which begs the question if the final exclusion, ["Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."] - actually means this population of 60%?
If GSK are going to pre-screen for this deficiency then any positive outcome of the trial will be cleverly disguised as an out and out success - 'The 'best' of a 'bad' bunch remember? Unless of course GSK step up to the plate and state clearly that 2D6 deficient subjects were removed
Are they trying to gain a license for Paxil in children in Japan because of the language barrier?
CYP450-2D6 is a phrase some of you may not have heard of before and, I believe, it's one that GSK don't want you to hear about either.
To cut a long story short, anyone who is deficient in the CYP450-2D6 Cytochrome can be at danger if they take Paxil. There is no easier way to say it folks.
This, I believe, bothers GSK with regard to Paxil, so much so that it was announced in March 2006 that GSK had 'solved' the Structure of Human Cytochrome P450 2D6 [1]
The 2D6 deficiency differs from culture to culture. In Asia approx 60% of the Asian population (Thai, Chinese & Japanese) are poorer than normal metabolizers of drugs such as Paxil, which primarily use the 2D6 enzyme.[2] Which begs the question if the final exclusion, ["Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study."] - actually means this population of 60%?
If GSK are going to pre-screen for this deficiency then any positive outcome of the trial will be cleverly disguised as an out and out success - 'The 'best' of a 'bad' bunch remember? Unless of course GSK step up to the plate and state clearly that 2D6 deficient subjects were removed
from the trial?
So in essence, GSK want a bunch of kids with MDD. They don't want these kids to have any of the illnesses, traits, habits included on their exclusion list - anything that may cause a negative finding during the trial.
So, let's predict that the Paxil NCT00812812 trial is a success for GSK. They are granted a license for Paxil, moreover for use of Paxil in Japanese children. How many children will then
So in essence, GSK want a bunch of kids with MDD. They don't want these kids to have any of the illnesses, traits, habits included on their exclusion list - anything that may cause a negative finding during the trial.
So, let's predict that the Paxil NCT00812812 trial is a success for GSK. They are granted a license for Paxil, moreover for use of Paxil in Japanese children. How many children will then
be prescribed Paxil by GP's, healthcare professionals who will use the same criteria as GSK did for the trial?
Take a look at the exclusion criteria again. Imagine if you will the scenario of a distraught
Take a look at the exclusion criteria again. Imagine if you will the scenario of a distraught
mother with her 16 year old son. She has gone to see her Japanese doctor because her son is showing signs of major depressive disorder. The exclusions for this trial need to be changed into questions for doctors to ask patients before they prescribe them Paxil. In this scenario, do you think the doctor would ask the mother of this child the following questions:
Is your son 2D6 deficient?
Does your son have predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc?
Has your son ever had any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases?
Does your son have a history of a bipolar disorder, or complication of these diseases?
Does he have Attention-Deficit, or Hyperactivity Disorder?
Does he have Mental Retardation or Pervasive Development Disorder?
Has your son ever taken any drugs that have led to Substance Abuse or Dependence?
Has he ever been treated with Paxil before?
Has he, in the past 12 weeks been treated with electroconvulsive therapy?
Does he have a past history of serotonin syndrome and neuroleptic malignant syndrome?
Does he have a CDRS-R score of "suicidal ideation" of 3 or greater. Or did his C-SSRS assessment suggest that they he has been a significant risk for harming himself or has actually harmed himself?
Does he have a past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)?
Does he have glaucoma?
Does he have convulsive disorders such as epilepsy or past history of these diseases?
Is he using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or has he had bleeding tendency or hemorrhagic diathesis?
Does he have severe renal and hepatic disorder?
Does he have a serious organic disorder in the brain?
Does he have chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody?
Does he have a current history of carcinoma or malignant tumor, or complication of these diseases?
Does he have clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)?
Finally, one question the doctor WILL NOT be able to ask this mother would be
Has he, in the opinion of a 'specialist', been judged as not appropriate for Paxil?
A huge list of questions for any doctor but ones that should be asked if Paxil is granted a license for use in children in Japan. If it's good enough for GlaxoSmithKline to exclude subjects from
Is your son 2D6 deficient?
Does your son have predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc?
Has your son ever had any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases?
Does your son have a history of a bipolar disorder, or complication of these diseases?
Does he have Attention-Deficit, or Hyperactivity Disorder?
Does he have Mental Retardation or Pervasive Development Disorder?
Has your son ever taken any drugs that have led to Substance Abuse or Dependence?
Has he ever been treated with Paxil before?
Has he, in the past 12 weeks been treated with electroconvulsive therapy?
Does he have a past history of serotonin syndrome and neuroleptic malignant syndrome?
Does he have a CDRS-R score of "suicidal ideation" of 3 or greater. Or did his C-SSRS assessment suggest that they he has been a significant risk for harming himself or has actually harmed himself?
Does he have a past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)?
Does he have glaucoma?
Does he have convulsive disorders such as epilepsy or past history of these diseases?
Is he using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or has he had bleeding tendency or hemorrhagic diathesis?
Does he have severe renal and hepatic disorder?
Does he have a serious organic disorder in the brain?
Does he have chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody?
Does he have a current history of carcinoma or malignant tumor, or complication of these diseases?
Does he have clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)?
Finally, one question the doctor WILL NOT be able to ask this mother would be
Has he, in the opinion of a 'specialist', been judged as not appropriate for Paxil?
A huge list of questions for any doctor but ones that should be asked if Paxil is granted a license for use in children in Japan. If it's good enough for GlaxoSmithKline to exclude subjects from
the trial because they don't meet the criteria then it's fair to say that doctors should be concerned and ask the patient or the patient's parents the above questions.
Two questions I have put to GlaxoSmithKline in an email are thus:
1- What exactly does the exclusion criterion "Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study" mean? What other criteria might this include not already listed. Could it possibly mean that children & adolescents will be pre-screened, by genetic testing to be sure that they are not deficient in the CYP450-2D6 enzyme that Paxil desperately needs to be safely cleared from a persons system. Will these kids not be included in the study?
2- Does the long list of exclusion criteria really represent the real world of kids that will be prescribed this drug in Japan,if it is approved. Will doctors use this same list of criteria when deciding to prescribe Paxil to their young Japanese patients?
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You have to ask yourselves if GlaxoSmithKline used the same criteria in other trials for Paxil other than trials for children. Whatever or whomever they excluded in all of the Paxil trials should be made abundantly clear to doctors before any prescription is ever wrote for Paxil - that's fair game isn't it?
Paxil has been proven to be as useful in children as a one-legged man at an arse kicking contest and as dangerous as giving them a loaded gun. I predict the results of this current trial will be favourable to GlaxoSmithKline. I also predict that doctor's will not be made aware of reasons NOT to give Paxil to children [Exclusions]
To put it bluntly and to use an analogy:
Here we have a rollercoaster in an amusement park, a rollercoaster that was condemned because it was faulty. The greedy amusement park owner wishes to re-open the rollercoaster, despite knowing how dangerous it is - so he has trial runs to prove to the public that children with ginger hair will be safe. Absurd isn't it - and nobody in their right mind would deem this acceptable behaviour. Yet here we have GlaxoSmithKline, the faultless pharmaceutical
Two questions I have put to GlaxoSmithKline in an email are thus:
1- What exactly does the exclusion criterion "Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study" mean? What other criteria might this include not already listed. Could it possibly mean that children & adolescents will be pre-screened, by genetic testing to be sure that they are not deficient in the CYP450-2D6 enzyme that Paxil desperately needs to be safely cleared from a persons system. Will these kids not be included in the study?
2- Does the long list of exclusion criteria really represent the real world of kids that will be prescribed this drug in Japan,if it is approved. Will doctors use this same list of criteria when deciding to prescribe Paxil to their young Japanese patients?
----
You have to ask yourselves if GlaxoSmithKline used the same criteria in other trials for Paxil other than trials for children. Whatever or whomever they excluded in all of the Paxil trials should be made abundantly clear to doctors before any prescription is ever wrote for Paxil - that's fair game isn't it?
Paxil has been proven to be as useful in children as a one-legged man at an arse kicking contest and as dangerous as giving them a loaded gun. I predict the results of this current trial will be favourable to GlaxoSmithKline. I also predict that doctor's will not be made aware of reasons NOT to give Paxil to children [Exclusions]
To put it bluntly and to use an analogy:
Here we have a rollercoaster in an amusement park, a rollercoaster that was condemned because it was faulty. The greedy amusement park owner wishes to re-open the rollercoaster, despite knowing how dangerous it is - so he has trial runs to prove to the public that children with ginger hair will be safe. Absurd isn't it - and nobody in their right mind would deem this acceptable behaviour. Yet here we have GlaxoSmithKline, the faultless pharmaceutical
company who are deluded enough to believe that they have never done any wrong where Seroxat/Paxil is concerned. They are re-launching the rollercoaster... but first they need a license and they will do everything in their power to gain that license.
I hope I'm wrong.
Bob Fiddaman
Author of Seroxat/Paxil Sufferers
http://fiddaman.blogspot.com
[1] Structure of Human Cytochrome P450 2D6 solved by GlaxoSmithKline with the use of Fludigm Technology - http://www.analytica-world.com/news/e/53265/
[2] Bernard eta al, J Pharm Sci 96-2007
RELATED STORIES
Japan/GSK - 329 All Over Again!
Glaxo - Turning Japanese!
Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812
GSK Just won't stop trying to push paroxetine on children!
Email to Ministry of Health - Japan
Japan Says Suicidal Cases Rise Among Paxil Users
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
I hope I'm wrong.
Bob Fiddaman
Author of Seroxat/Paxil Sufferers
http://fiddaman.blogspot.com
[1] Structure of Human Cytochrome P450 2D6 solved by GlaxoSmithKline with the use of Fludigm Technology - http://www.analytica-world.com/news/e/53265/
[2] Bernard eta al, J Pharm Sci 96-2007
RELATED STORIES
Japan/GSK - 329 All Over Again!
Glaxo - Turning Japanese!
Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812
GSK Just won't stop trying to push paroxetine on children!
Email to Ministry of Health - Japan
Japan Says Suicidal Cases Rise Among Paxil Users
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Thursday, July 23, 2009
GlaxoSmithSwine
Glaxo unmasked: drug firm to make £1bn from swine flu
Source: Independent Minds
GlaxoSmithKline (GSK) is to sell the vaccine for up to £6 a dose in Western countries, and the first supplies are due to arrive in Britain in September.
Andrew Witty, GSK's chief executive, refused to apologise for the boost in earnings, pointing out that GSK had invested more than $2.5bn (£1.5bn) in its vaccine development programme over the past few years.
"Swine flu is going to be positive for the performance [of the company], but only because we have put ourselves in a position to do it," he added. "And we have done that by taking very significant risks over a long time, diverting a huge amount of resources to it and doing the research that nobody else has done, so I'm not going to apologise for the fact that the company is going to make a return."
Read more HERE
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Tuesday, July 21, 2009
Seroxat Withdrawal - What GSK keep from the Patient.
ABC PRIMETIME LIVE - PAXIL ADDICTION
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Click on PDF Logo to download file
GlaxoSmithKline program called “Psychnet”
Section 3: Issues Management: Managing the Discontinuation Issue.
Paxil Litigation Documents
DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS
More GSK Files at http://gskfiles.blogspot.com/
----
Click on PDF Logo to download file
GlaxoSmithKline program called “Psychnet”
Section 3: Issues Management: Managing the Discontinuation Issue.
Paxil Litigation Documents
DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS
More GSK Files at http://gskfiles.blogspot.com/
Any News on the Paxil Kids Yet?
Protocol Summary for 112487
Protocol Id: 112487
Secondary Ids: N/A
Title: A randomised, double-blind, placebo controlled, parallel group , flexible dose study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder.
Phase: Phase 4
FDA Regulated Intervention? No
Study Type: interventional
Oversight Authority: Japan: Ministry of Health, Labour and Welfare
Brief Summary: This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes: To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD based on the change from baseline to Week 8/end-of-study in the CDRS-R total score no 8 weeks.
Secondary Outcomes: To compare the safety of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD no 8 weeks.
To assess the plasma concentrations of paroxetine administered orally at Week 8 or withdrawal in subjects with MDD. no 8 weeks.
Conditions: Major Depressive Disorder
Keywords:
children and adolescents
paroxetine
CDRS-R
selective serotonin reuptake inhibitor
Gender: Both
Minimum Age: 7 years
Maximum Age: 17 years
Central Contact: US GSK Clinical Trials Call Center
Central Contact Email: info@clinicaltrialsforgsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Responsible Party Organization: GSK
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Related Links
MHRA Investigation into Glaxosmithkline/Seroxat
Paxil Study 329
Tuesday, July 14, 2009
GlaxoSmithKline agrees royalty-free licensing deal for HIV drug
The Good News:
Tuesday 14 July 2009
Source - The Guardian
Tuesday 14 July 2009
Source - The Guardian
GlaxoSmithKline has granted South Africa's Aspen the right to make its HIV drug abacavir in a royalty-free licensing deal, on the day that a group of MPs called on manufacturers to put their HIV medicines in a "patent pool" to reduce prices.
Aspen will manufacture a cheaper, generic version of abacavir, also known as Ziagen. The deal was announced by GSK chief executive Andrew Witty on a visit to Kenya today and forms part of the company's efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.
The world's second-largest drugmaker also announced a new £50m fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV. A further £10m will go to support public-private partnership work in developing Aids medicines for children.
The Bad News:
Monday, 12 May 2008
Source - The Independent
The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered potentially fatal heart attacks following the use of its £600m anti-Aids drug, which is taken daily by tens of thousands of people around the world.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and its antiviral drug abacavir are both “unexpected” and “unconfirmed”.
Alastair Benbow, European medical director for GSK, said that the company takes any new information about the safety of its drugs seriously but it did not want to highlight what may be “spurious observations” relating to abacavir.
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Aspen will manufacture a cheaper, generic version of abacavir, also known as Ziagen. The deal was announced by GSK chief executive Andrew Witty on a visit to Kenya today and forms part of the company's efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.
The world's second-largest drugmaker also announced a new £50m fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV. A further £10m will go to support public-private partnership work in developing Aids medicines for children.
The Bad News:
Monday, 12 May 2008
Source - The Independent
The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered potentially fatal heart attacks following the use of its £600m anti-Aids drug, which is taken daily by tens of thousands of people around the world.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and its antiviral drug abacavir are both “unexpected” and “unconfirmed”.
Alastair Benbow, European medical director for GSK, said that the company takes any new information about the safety of its drugs seriously but it did not want to highlight what may be “spurious observations” relating to abacavir.
----
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
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