Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Wednesday, December 29, 2010

Paxil Malformations - Who Is Responsible?



A study from earlier this year by M. Reis and B. Källén showed that paroxetine [brand names, Seroxat, Paxil and Aropax] seems to be associated with a specific teratogenic property.

The study was carried out because of concerns about possible adverse effects of the use of antidepressant medication during pregnancy, including risk for neonatal pathology and the presence of congenital malformations.

This particular study, entitled, "Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data", was published in the Cambridge University Press early 2010.

Data from the Swedish Medical Birth Register (MBR) from 1 July 1995 up to 2007 were used to identify women who reported the use of antidepressants in early pregnancy or were prescribed antidepressants during pregnancy by antenatal care: a total of 14,821 women with 15,017 infants.

The conclusion?

"Women using antidepressants during pregnancy and their newborns have increased pathology. It is not clear how much of this is due to drug use or underlying pathology. Use of TCAs was found to carry a higher risk than other antidepressants and paroxetine seems to be associated with a specific teratogenic property."

Not so much of a conclusion really as it can be argued that is not clear how much of this is due to drug use or underlying pathology - this is the basis of arguments used in court rooms or 'negotiating tables' with GlaxoSmithKline's lawyers across the US.

The majority of Paxil birth defect cases have been settled out of court, the odd one or two have been lost by the claimants on legal technicalities.

The Reis/Källén study is quite significant in as much that it fingers GSK's Paxil as not only being associated with a specific teratogenic property, it also shows that pregnant patients taking Paxil increase the chances of their babies being born with cardiovascular defects and hypospadias.

What is hypospadias?

Hypospadias is a congenital (present at birth) problem affecting a boy’s penis. It is a combination of three separate problems: the hole through which urine passes (meatus) is not at the tip of the penis, the foreskin is gathered at the back of the penis with none at the front and the penis may be bent when stiff. The position of the meatus varies; in some boys, the hole is only a small distance away from the tip of the penis, whereas in others, it is at the base of the penis, in the scrotum or behind the scrotum. [1]

According to the Great Ormond Street Hospital for Children NHS Trust website, about one in every 300 boys has hypospadias, although this figure seems to be rising. It is not known why this figure is rising. So we have that grey area of whether or not paroxetine increases the chances of a male child being born with hypospadias. The Reis/Källén study seems to suggest that it does.

Who is responsible?

So, the question, who is responsible falls into the pot. Do we point the finger of blame at the manufacturer of Paxil, GlaxoSmithKline or do we scrutinise the body who regulate and license drugs in the UK, namely, the MHRA?

Even if blame is placed upon either of these two, who, or more importantly, whom is responsible? What individual should take the blame for allowing a known teratogen to be prescribed to pregnant patients?

Surely, whomever it is, should be in a position to answer questions from concerned members of the public, moreover, consumers of a product.

The CEO of GlaxoSmithKline is Andrew Witty. Should Witty go public and offer an explanation as to why a drug manufactured by the company that he heads could increase the chances of heart and hypospadias malformations? It's one thing adding a warning to the ever increasing [in text] patient information leaflet [PIL] - but is this really enough? In any event, would this really be advisable considering GlaxoSmithKline are settling and defending many hundreds of Paxil birth defect trials in America?

Or do we expect more from the MHRA's CEO, Kent Woods?

The MHRA's role is to protect the public from unsafe drugs. With paroxetine top of their adverse reactions list, they could argue that they are doing enough.

The MHRA, like Glaxo, have half heartedly warned people of the risks of taking paroxetine whilst pregnant. What they haven't done is label it a teratogen. One would have thought that lessons were learned for the most infamous teratogen of them all, Thalidomide, a drug that was mainly prescribed to pregnant women for morning sickness in the late 50s and early 60s. Instead the drug caused severe deformities in babies with missing limbs.

Are we on the brink of Déjà Vu here?

There is a fine line of protecting patients with regard to paroxetine use. The MHRA tout the risk/benefit ratio and they, apparently, would not want to alarm the public over paroxetine's propensity to cause malformations because they are [still] of the opinion that the benefits of taking paroxetine outweigh the risks.

The Reis/Källén study would suggest otherwise.

Wise up - pull the drug.

The study is available for download [for a fee] HERE



[1] What is hypospadias?


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Thursday, December 23, 2010

The Evidence, However, Is Clear...The Seroxat Scandal - - The Final Hurdle




I'm at the final hurdle of the editing process of my manuscript for my book, 'The Evidence, However, Is Clear...The Seroxat Scandal.'

It has been quite a struggle, yet my editor has taught me a valuable lesson in patience.

Much has changed from the original ebook version. It's been a privilege to work alongside a great editor, more so because she was hired by someone who believes this damn book is worth reading. I won't embarrass him but thank him from the bottom of my heart.

We are looking at January or February for its release in paperback form.






Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, December 22, 2010

2010: GlaxoSmithKline - This is the Year That Was



A recent post appeared on the lawyersandsettlements.com website entitled, 2010: Annus Horribilis for GlaxoSmithKline. The post highlighted the various Paxil [Seroxat] settlements that Glaxo have been making throughout 2010, in the main for accusations that Paxil causes birth defects. Furthermore, Glaxo have also had a pretty bad year where their diabetes drug, Avandia, is concerned. Avandia was withdrawn from the European market annd many lawsuits will no doubt follow. Then there was the Peurto Rico plant debacle where the whistle was blown on GSK for knowingly manufacturing, distributing and selling medications that did not meet FDA standards.

Tough year?

It was much worse than that.

This is the year that was 2010.

JANUARY:

January 14, 2010 - Swine flu taskforce's links to vaccine giant, Glaxo!

January 30, 2010 - GlaxoSmithKline Fined $5.8 Million

FEBRUARY:

February 19, 2010 - GNASH GNASH GNASH - Another GSK product pulled!

February 26, 2010 - GlaxoSmithKline Loses Bid for Immunity From Suicidal Behavior Lawsuits.

MARCH

March 07, 2010 - GSK's ALLI - "Major health warning issued..."

March 08, 2010 - Glaxo's Lucozade Linked to Hyperactivity.

March 11, 2010 - Dr Nissen - Avandia - "The company [GSK] first heard that their drug was hurting people's hearts in the fall of 2005"

APRIL

April 16, 2010 - FDA Haul Glaxo Over The Coals for Misleading Advertisement.

April 24, 2010 - Numb The Movie - The Hell of Paxil Withdrawal.

MAY

May 11, 2010 - Glaxo's $60 Million in Avandia Settlements‎.

May 13, 2010 - GSK's Titty Tantrum Over Cafe Pharma.

May 31, 2010 - GSK Weight-Loss Drugs Rapped With Warning Label.

JUNE

Most of June - Death by Paxil - The Sara Carlin Inquest.

JULY

July 11, 2010 - Scathing Review of Glaxo's Avandia Clinical Trial.

July 21, 2010 - Glaxo Quietly Settling Paxil [Seroxat] Lawsuits.

July 21, 2010 - Glaxo's Profits Hit New Depth.

AUGUST

August 06, 2010 - This Little GSK Piggy Didn't Go To Market.

August 13, 2010 - Fresh Woes for Glaxo's Lamictal.

August 18, 2010 - Prescription for Bribery.

August 20, 2010 - 13 Months Jail Term For Glaxo's Hired Psychiatrist.

August 22, 2010 - Legal Action Against Glaxo for "Guinea Pig Trials"

August 23, 2010 - Pressure mounts for GSK [inquiry into trials of vaccines]

August 27, 2010 - Glaxo Under Bribery Investigation in Finland.

August 29, 2010 - Average Paxil Birth Defect Settlement $1.2 Million.

August 31, 2010 - Law Firm Announces Fresh Investigation into GlaxoSmithKline.

SEPTEMBER

September 06, 2010 - Another fine job by Shelley Jofre - A Risk Worth Taking?

September 07, 2010 - GlaxoSmithKline shares hit by call to withdraw Avandia.

September 08, 2010 - Seroxat used in Ireland to distort childhood memories of abuse.

September 21, 2010 - Glaxo Sued Over Exclusive Licensing Contract.

September 23, 2010 - GSK's AVANDIA IS TOAST... IN EUROPE ONLY.

September 27, 2010 - GSK - 'There's no business like monkey business'

OCTOBER

October 29, 2010 - GlaxoSmithKline - Filthy, Disgusting, Abhorrent...and that's Just the Plant! Read the Charges!

October 31, 2010 - "The simple story is that GSK were running a factory in Puerto Rico that was more or less out of control"

NOVEMBER

November 01, 2010 - SHOW ME THE WAY TO PUERTO RICO [WHISTLEBLOWER VERSION]

November 02, 2010 - GlaxoSmithKline and the Promotion of the Cervarix Vaccine.

November 05, 2010 -UK Seroxat Litigation [The background]

November 09, 2010 - Glaxo's Associate General Counsel Indicted For Obstruction.

November 10, 2010 - Glaxo's Dirty Little Secret is out - It was Wellbutrin!

November 13, 2010 - Will GSK Lawyer, Lauren Stevens, Squeal Like A Little Piggy?

November 18, 2010 - GlaxoSmithKline Influences Experts To Boost HPV Vaccine Sales.

November 19, 2010 - ARE HEALTH CANADA PROTECTING GLAXO FROM LIABILITY?

November 29, 2010 - GlaxoSmithKline - $5000 Per Child.

November 30, 2010 - GLAXO NAMED AND SHAMED IN BOOK SCAM!

DECEMBER

December 08, 2010 - GSK's Statement of Spin - Paxil Birth Defects.

December 17, 2010 - GLAXOSMITHKLINE TOP THE CHARTS...BUT FOR ALL THE WRONG REASONS.

GlaxoSmithKline
Do more, feel better, live longer


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tuesday, December 21, 2010

Labelling Children with "Mental Disorders"

A new 90 second video from the stable of CCHR, the only dialogue coming in the form of labels.

This is a work of genius, a concept that pretty much sums up how easy it is to stick a label on a child who...is just being a child.

There's no disclaimer with this video. I've gone beyond explaining myself regarding the work of CCHR. If the pharmaceutical whores or ignoramuses wish to make outlandish connections then more fool them. Ironic that a video about labelling will more than likely cause a small minority to label.

The message is clear...now, are we going to sit back and do nothing?



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Friday, December 17, 2010

GLAXOSMITHKLINE TOP THE CHARTS...BUT FOR ALL THE WRONG REASONS



It's a dream of anybody to one day top the charts. A musician just setting out in showbiz, a budding author with their first novel, just two examples of the heights some people wish to climb to.

In the case of corporate businesses, it's pretty much the same. They all want to be the best at what they do - they want to sit proudly at the top of the charts to show the world of business just how successful they are.

Pharmaceutical companies are no exception. They want the best drugs, the best reputation, the best annual turnovers for their shareholders.

I'm left wondering what GlaxoSmithKline's shareholders think of the following study from The Public Citizen’s Health Research Group.

The purpose of the study was to compile a comprehensive database of all major criminal and civil settlements between federal and state governments and pharmaceutical companies.

Well, Glaxo have topped the charts again.

Pharmaceutical Company Penalties: Worst Offenders sees Glaxo sit top of the pile with almost double the financial penalties imposed on them compared to their closest rivals, Pfizer.

What have you done today to make you feel proud?


Ed Silverman over at Pharmalot delves deeper into the study.

In the meantime...







DO MORE, FEEL BETTER, LIVE LONGER



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Seroxat in China - Why no fuss?



A recent article from Pharma Times indicated that Seroxat/Paxil [paroxetine] was the most widely used antidepressant in China with a market share of 18%.

What could be different in China compared to the western world?

Well, for one, if Seroxat was giving cause for public concern, I doubt if you would find any Chinese activist blogging about it. Freedom of speech is pretty much unheard of in China, even in the land of cyberspace. Who, in their right mind, would want to put their freedom on the line and speak out against an antidepressant drug and the company that makes it?

Secondly, the Chinese State Food & Drug Administration [SFDA], the equivalent of the FDA and MHRA, have a pretty dark history when it comes to corruption.

In April this year, five officials from the SFDA were arrested for allegedly accepting bribes whilst a sixth was suspended from duty.

It was the second major bribery scandal concerning the SFDA in less than four years. Zheng Xiaoyu, former head of the SFDA, was executed on July 10, 2007 for taking bribes of 6.49 million yuan for approving licenses for new drugs.

Finally, GSK has major operations in China. GlaxoSmithKline (China) Investment Co., Ltd, Sino-American Tianjin Smith Kline & French Laboratories Ltd, GlaxoSmithKline (Tianjin) Co., Ltd, GlaxoSmithKline Pharmaceuticals (Suzhou) Ltd and GlaxoSmithKline Biological (Shanghai) Ltd.

I assume it would be in the interests of the Chinese government to bend over backwards for GlaxoSmithKline. I mean, why bite the hand that feeds you?

Got me thinking. Maybe the title of this song could have been written with GlaxoSmithKline in mind?





Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Thursday, December 16, 2010

...They just wouldn't go away.

"One small step for man...one giant leap for mankind"







Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Friday, December 10, 2010

Numb Documentary - Paxil/Seroxat Withdrawal.



Working with Executive Producer Melody Gilbert, first time director Phil Lawrence shares his own personal experience with Paxil/Seroxat in a way that he hopes will spark conversation about the issue of Paxil/Seroxat withdrawal.

This documentary is Phil’s story.

Trailer



Visit the Numb website HERE

Numb on Facebook HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wikileaks Target Pfizer

Image: venturebeat.com


Those who wish to keep their secrets under lock and key must be having sleepless nights of late, none more so than the pharmaceutical industry.

Many cases against pharma are settled before they even reach the steps of many court rooms, with the settlement comes the sealing of evidence and a statement of 'No liability' from pharma.

Recently the controversial website Wikileaks has released documents that show how Pfizer hired investigators to uncover corruption links to Nigeria’s Federal Attorney General Michael Aondoakaa and leaked reports of alleged corruption to local Nigerian media outlets in February and March of 2009.

Why would Pfizer do this?

Well, at the time it was alleged that Pfizer conducted an illegal clinical trial on Nigerian children during a 1996 meningitis outbreak. The Nigerian government was seeking $8.5 billion in restitution and damages as well as jail terms for various Pfizer officials.

Naughty Pfizer.

It does not surprise me that they would resort to such tactics.

There will be many squeaky bums throughout the world of pharma. A disgruntled pharma employee, or even an employee from the many offices of attorneys who have had access to items of disclosure in pharmaceutical litigation trials may just get itchy fingers and start typing to Wikileaks.

I can wait.

Dirt on Pfizer HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, December 08, 2010

GSK's Statement of Spin - Paxil Birth Defects.

Image: topnews.in


News filtered through in late November that GlaxoSmithKline had apparently received a favourable judgement in a case alleging that use of Paxil during pregnancy caused 14-year-old Anna Blyth to be born with certain cardiac birth defects.

In a media release on the GSK website, Glaxo claim that "...it acted properly and responsibly in researching and studying Paxil, including sharing documentation and submitting results from studies on Paxil to regulators."

What GSK conveniently fail to mention is the reason why this particular case seemingly collapsed.

Inside sources tell me that the Blyth case was dismissed on a legal technicality. The Judge [Judge Glazer] believed that the prescribing doctor’s testimony [that he might not have prescribed Paxil had he been properly warned of Paxil birth defect risks] was necessary in this case. Sadly, the doctor is deceased and his testimony could not be obtained so the judge granted GSK’s motion to dismiss the case.

The GSK statement also fails to mention that the ruling by Judge Glazer is currently under appeal.

In other words, GSK's media statement has been spun in such a way that it appears Paxil is pretty safe for use during pregnancy and played no part in Anna Blyth being born with certain cardiac birth defects...at least, that's the impression it gives me upon reading it.

I do wish GSK would release all the facts occasionally!

Related stories: KILKER v GLAXOSMITHKLINE COURT DOCUMENTS

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Monday, December 06, 2010

SUSAN SCHECHTER IS BACK

Susan Schechter, the author of the popular blog, 'If you're going through hell keep going', is now out of hospital and has added her first post since being hospitalised.

Good to see you back Susan!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Sunday, December 05, 2010

3 PARA COMES HIGHLY RECOMMENDED



Totally off topic, my son, who is serving in the Armed Forces out in Afghanistan, managed to send me a few emails the other day, thankfully he is back at Bastion after spending a month out in the wilderness, surviving on Army rations, using bottled water to wash, all the time watching where he and his fellow comrades step because of IED's planted underneath the soil by Taliban insurgents, not to mention coming under sporadic fire from the enemy from both machine gun and mortar shells.

I see various sources on Wikileaks are condemning the British forces, probably some pen-pushing cretin who takes a bath with scented oils and has candles around their bath whilst listening to Mozart.

In today's Telegraph, General David Petraeus, the commander of Nato troops in Afghanistan, singles our 3 Para and praises them, citing; "the most impressive way to do business"

3 Para were involved in an operation that left 15 Taliban dead but left civilians unharmed. In fact during the last month or so, 3 Para have killed more than 40 Taliban and even captured a shadow Taliban governor.

As a parent, not a day goes by when I don't think of my son fighting alongside this unique company of soldiers. His training was brutal, he now understands why it had to be so brutal. Every newsflash regarding this war sinks my heart - heaven forbid I ever get representatives of the British Army or Police force knock on my door - [ I actually did the other morning but that's a story that will keep...for the time being]

The Afghan terrain, particularly out in Shazhad, is warm in the day and sub-zero at night - these brave men go weeks on end eating their rations, crouch against walls to defecate into a plastic bag and wash with a bottle of water to stop fungal infections growing upon their person.

They are elite, brave, have no fear and all heroes in my book.

To the men of 3 Para, I salute you. You are all heroes and I shall live forever in your debt.

Related stories

Gen Petraeus hails Paras for precision attack

British Paras see progress in the fight against the Taliban - and in the schools

Paratroopers defeat Taliban in decisive day of battles



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Friday, December 03, 2010

Will Former Glaxo Lawyer Squeal?

Image: westword.com


A date has been set on Feb 1 for former Glaxo lawyer, Lauren Stevens, to answer charges of obstructing an official proceeding, concealing and falsifying documents to influence a federal agency, and five counts of making false statements to the FDA.

Will Stevens rat out other attorneys on Glaxo's payroll?

The three week trial should give us the answers.

More over at Ed Silverman's Pharmalot.

Back story:

Glaxo's Dirty Little Secret is out - It was Wellbutrin!

WELLBUTRIN - THE BONEY M REMIX



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, December 01, 2010

TIME TO START BLOWING THE PHARMA WHISTLE



U.S. lawyers Baum, Hedlund, Aristei & Goldman have been representing antidepressant victims for almost two decades in high-profile cases against major pharma companies like GSK, Pfizer and Eli Lilly, challenging antidepressant efficacy and safety. Their litigation success and advocacy efforts in this field are the subject of numerous articles, news stories, documentaries, books and blogs. They have backed congressional movements toward more aggressive drug safety, not only in the U.S., but European and Asian countries as well. Given their extensive experience in investigating drug company wrongdoing, they now also represent whistleblowers of pharmaceutical fraud.

Get in touch - Click on the banner.




Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Please contact me if you would like a guest post considered for publication on my blog.