I’m not one for nostalgia… But check this out…


http://www.webspawner.com/users/glaxo/index.html

Rob Robinson .. the original Paxil (Seroxat) activist..
This guy rocks..
.

http://www.webspawner.com/users/glaxo/index.html

From the home office of GlaxoSmithKline’s CEO:

Jean-Pierre Garnier
349 Pond View Road
Devon, PA 19333

Dear Paxil/Seroxat Victim,

Not only did GlaxoSmithKline con you into taking PAXIL (Seroxat in the U.K.) — along with your healthcare provider who unwittingly prescribed it — untold numbers of you are addicted to it now. Which is a good thing since we at GSK are addicted to corporate profits (see GlaxoSmithKline 1997 confidential company document* at right) and, quite frankly, could care less about the pain and misery, the suffering and even death, that Paxil has spawned — as a direct result of our fraudulent promotion of the drug.

In fact, as far as GSK is concerned your health and well-being is on a par level with that of a disposable lab rat. On second thought maybe that’s a little too harsh; I’m not suggesting we don’t value you … far from it. After all, lab rats don’t have healthcare plans or bank accounts that can pay to have Paxil prescriptions filled. Yes?

If you’re like many Paxil users at some point you figured out you couldn’t stop taking “the drug” without experiencing oftentimes severe and distressing symptoms … electroshock sensations radiating throughout your head for instance. And that, of course, is just for starters. Isn’t it great! For us, I mean. See, you have to keep taking Paxil to make the discontinuance, I mean withdrawal, symptoms stop. (We had to start using the word “withdrawal” a few years ago after some do-gooder lawyers from California sued us.)

Of course, many of you risked it all to escape from our “Alcatraz in a pill bottle” — and lived to tell about it. And thousands of you are suing us in the U.S. and Britain … all because of that one little silly word. (Hundreds of you have also sued us because someone in your family killed themselves right after they started taking Paxil, or while they were trying to stop taking it, but we’re quietly settling all of those cases out of court so let’s not even talk about that. Its not a pleasant subject.)

I’ve got a lot more I’d like to share with you in this open letter and indeed I will likely expand it a bit more later on, but I’m getting all misty eyed at the moment as I think of all the dedicated Paxil addicts working hard and dutifully taking their daily dose of rat poison, I mean, Paxil — so GSK can continue raking in billions of dollars in Paxil profits every year. It’s a beautiful thing you know. Our scheme, that is.

Anyway, let’s have some fun shall we? Happy smiling faces and all that. Immediately following this letter you’ll find some of the neat stuff GSK is working to bring to your cyber doorstep. We hope you enjoy it, and believe it’s the least we can do. It’s all about being a good corporate citizen.

Finally, before I forget … on behalf of all of us at GLAXOSMITHKLINE I’d like to say “”thank you” — and don’t forget to “EAT MORE PAXIL” (Otherwise I won’t be able to afford upkeep for my assortment of multi-million dollar homes (and ski bungalows: one in Aspen, Colorado and another in the French Alps), maintain my Leer jet, my sports cars ( a Lamborgini and a Porsche), monthly restocks of my wine cellar … you get the idea.

Sincerely,

J.P. Garnier, CEO
GlaxoSmithKline

“GSK’S ELABORATION OF THE GIST”

*What we (GSK) knew about Paxil when it was first developed — and didn’t tell you (or your physician.)

KUDOS FROM GSK

*A special “thank you” note to everyone who chose to become a Paxil addict.

*A “thank you” note to employees of the FDA who accepted bribes from GSK (then SKB) to allow Paxil into the marketplace, and helped those people thanked above (become addicts.)

*GSK’s “Paxil Suicide Hall of Fame.” Dedicated to those Paxil victims for whom “Paxil addiction just wasn’t enough.” Located in GSK’s Philadelphia, PA headquarters.

GSK GIFT CERTIFICATES AND ON-LINE CREDITS

*A (generous) $25 gift certificate redeemable online at “Flowers-R-Us” for survivors of Paxil suicides.

*A (super generous) $100 credit towards the purchase of a grave marker for children who killed themselves whilst taking or withdrawing from Paxil.

*A (generous) $75 Amazon.com gift certificate good towards the purchase of Post Traumatic Stress Disorder self-help books (for Paxil withdrawal-induced PTSD.)

FROM GSK’S IN-HOUSE PRESS

*A book of poems penned by GSK employees; inspired by fantasies of your Paxil withdrawal.

*A pamphlet entitled “Bad Paxil Withdrawals And How To Have Them.”

*A book of Paxil withdrawal jokes authored by top GSK executives.

*A one-year subscription to “The Zaps” (a comic book series that “looks at the lighter side” of this pesky Paxil withdrawal symptom.)

*A two volume set entitled “Welcome To The Abyss: A Paxil Withdrawee’s Field Guide To PaxHell.”

*A do-it-yourself Paxil withdrawal guide. Note: DOES NOT include information about converting over to a competitor’s product (Prozac) when tapering from Paxil doesn’t work.

*A cute, GSK children’s cartoon coloring book entitled “Paxil Withdrawal Hell: Why Do I Want To Kill Myself, Mommy.”

*“Dante’s Inferno: The Paxil Sequel” by GSK President J.P. Garnier. Note: leatherbound with engraved gold lettering.

*“The Myth Of Paxil Withdrawal” by GSK’s Minister of Paxil Propaganda, Dr. Alistair Benbow. A 300 page tome, of which 299 pages are blank. Page one simply says “Whilst I have every sympathy for anyone who may have suffered side effects whilst taking Paxil … I still must say its only discontinuance syndrome.”

*An information leaflet entitled “Discontinuance Syndrome: Defined At Last.” (I’ll save you some time … Discontinuance Syndrome is the phenomenon whereby countries ban or severely restrict the distribution of Paxil.)

*“Dancing Behind GSK’s Corporate Veil: How To Rape And Pillage For Drug Profits, Maintain Personal Anonymity, Avoid Personal Accountability And Sidestep Liability.” A huge block of a book, with contributions by numerous GSK top execs.

*Let Them Eat Rat Poison” by Dr. Anne Phillips, Vice President, Research & Development and Chief Medical Officer, GSK. Reviewed by the “Prisoner of Paxil” who wrote “an insightful book which provides the reader with a clear understanding as to why Paxil was turned loose an unsuspecting public. As Dr. Phillips says in her foreward “Its all about the money, BABY! Yahoo!”

*”Poisoning People With Paxil For Fun And Profit” by GSK spokesperson Mary Ann Rhyne. A frank discussion of the critical components needed to pull off a massive corporate drug fraud, including: dummied up field studies, successful collusion with insiders at public institutions (like the FDA), how to silence Paxil victims by buying them off (for pennies on the dollar) and more!

*“The Living Dead: Human Paxil Lab Rats And How To Trap Them” by Dr. Philip Perera, psychiatrist and group director for clinical psychiatric research at GSK.

*A GSK consumer leaflet entitled “So You Had Millions Of Nuerons Fried By Paxil Withdrawal … So What Now?” How to “rebuild your withdrawal-damaged brain” using common household items like superglue and duct tape.

AVAILABLE FROM GSK’S ON’LINE PAXIL “SOUVENIR” SHOP

*A t-shirt emblazoned with the line: “I Went Through Paxil Withdrawal Hell … And All I Got Was This Lousy T-Shirt.” An eye-catching graphic on the back of the shirt depicts a crumpled human body fused to a dead rat’s head.

GSK POSTERS, PHOTOS, SCREENSAVERS AND MORE

*A glossy 8” x 10” color photo of GSK’s Minister of Paxil Propaganda, Dr. Alistair Benbow being quoted as saying “Whilst I have every sympathy….” Suitable for framing. Signed. Limited printing.

*A DVD of Dr. Alistair Benbow receiving the Dr. Joseph Mengele Award of Excellence on behalf of GSK. Presented by several still-living members of the defunct Third Reich. “Rich in sentimental value.”

*A four-color, two-panel poster. Panel #1 depicts a GSK employee poised to drop a replica of an oversized human brain into the maw of a commercial-grade wood chipper. Subtitle: “This is your brain before Paxil withdrawal.” The second panel depicts a close up shot of a chipped pile of gore. Subtitle: “This is your brain going through Paxil withdrawal. Any questions?”

*A free poster reproduction of Munch’s “The Scream” subtitled “Paxil Withdrawal: My Trip To Hell On Earth.” (Suitable for framing.)

*A four color poster of an exposed human brain capped by an atomic mushroom cloud. Subtitled with a quote from GSK President J.P. Garnier who exclaims “Paxil withdrawal — ain’t it a blast!”

*A computer screen saver of Hieronymous Bosch’s depiction of Hell … with your own image scanned into the scene — along with a legion of Paxil pills chasing you to and fro amongst the flames. Specify Mac or Windows when ordering.

*A free bumper sticker “Paxil withdrawal … are we having fun yet?!”

*An 8” by 10” full color photograph of GSK President J.P. Garnier displaying an oversized Paxil pill bottle in one hand — and the dismembered head of a small child (who died whilst in Paxil withdrawal) dangling by its hair in the other. Taken at a recent corporate retreat in Aspen, Colorado.

*An autographed, four-color poster of GSK spokesperson and Paxil CR chompin’ NFL legend Terry Bradshaw — who told an interviewer in 1980 “I’m just going to answer as openly and honestly as I possibly can. And when I think it’s really controversial, I’ll just lie.” (Second Bradshaw poster with inscribed quote available as follows: When asked by the same interviewer “Were you ever at a point where you were just curious to try a drug — to see what it would do?” Bradshaw replied “No, I never cared anything about it. All I’ve heard about drugs is bad, so why get hooked on something that’s bad? You know. As the old cat says, I’m high on life, pardner.”

* A bumper sticker that reads “Terry Bradshaw Says: Eat More Paxil”.

GSK CURIOS AND NOVELTY ITEMS

*A miniature Telsa coil. Sprays electrical energy throughout a small globe mounted on a special, insulated stand. (So when someone visits you at home and asks you “what do you mean you have ‘the zaps’” … you can turn this device on and show them what’s happening inside your head.) Free, but quantities are limited.

*A gold-plated .32 caliber revolver, butt-inscribed with a calligraphic quote by GSK President J.P. Garnier that reads: “Good luck with your Paxil withdrawal.” Note: this is an on-line auction item. Date to be announced.

*A sterling silver, serrated 12” butcher knife, face-inscribed with a calligraphic quote by GSK spokesperson Michael Fleming that reads: “Here’s ‘a little helper’ in case your Paxil withdrawal goes really, really bad. But remember, Paxil has helped millions and millions of people….”

*A miniature bronze statue of GSK’s 2004 Employee of the Year, legal counsel Daniel Troy, who worked “in field” for GSK at the Food and Drug Administration’s Washington office.

*A football-sized Paxil pill autographed by GSK spokesperson and sports celebrity … Paxil CR chompin’ NFL legend Terry Bradshaw.

*A giant rat trap (scaled to human size) baited with a bottle full of Paxil pills. Mahogany base plate. A perfect conversation piece to add “a bit of spice” to any Paxil victim’s living room decor. Note: Not suitable for display in homes with children.

*A free (oversized) campaign-style button that reads: “Paxil withdrawal … are we having fun yet?!”

*A life-sized puppet replica of Dr. Mark McClellan, former head of the Food and Drug Administration. Strings included!

*”Paxil Withdrawal — The Board Game.” (Similar in theme to Monopoly.) Sorry, no “get out of Paxhell free” cards included. Game pieces are color-coded Paxil tablets in various milligram doses.

GSK-SPONSORED CONCERTS, MUSIC AND MORE

*A pair of free concert tickets to see the GSK-sponsored rock group the “Global Serial Killers.” Top stage hits include: “Off Label Them Kiddies (But Don’t Off’em),” “PANES Ain’t Such A Pain,” “Discontinuance Syndrome Blues,” “Benbow Ain’t No Boogieman,” “Welcome … To The Paxiltorium,” and “Human Lab Rats.”

*And for your “at home” or “in car” listening pleasure … GSK’s top-selling CD. Includes chart smashers like: “Night of a Thousand Nightmares,” “Tinnitus Symphony,” “I Forgot To Take My Paxil (and Went on a Murderous Rampage),” “Ode to Alistair (Symphony From Hell, Part I),” “Voulez-Vous Coucher Avec Moi, Jean-Pierre? (I Promise I Won’t Kill You)” and “They Said It Wasn’t Addictive.”

*A pair of complementary tickets to see the opening of “PaxHell —The Musical.” Features a dance corps comprised of GSK execs (and their goons at the FDA) singing the opening song “We Hooked Them.”

GSK “MANAGING YOUR PAXIL WITHDRAWAL”: MISCELLANEOUS

*An essay contest for Paxil withdrawees afflicted by PANES (Persistent Adverse Neurological Effects and Symptoms.)

*An on-line application to register for a free stay at GSK’s legendary “Paxiltorium.” Hot Tip: Be sure to register well before your Paxil withdrawal force feeds your sanity through the bio-equivalent of a high speed paper shredder.

*PaxHell — “The Reality Show.” PaxHell is a real life drama, hosted by GSK’s own Dr. Alistair Benbow, consisting of ten “contestants” suffering through various stages of Paxil withdrawal … whist living together in a beautiful resort home owned by GSK (normally reserved for GSK execs to vacation at.) A GSK weekly webcast of the show includes “all the best clips” from each week’s episode. Tension on the set is heightened by the lack of informed medical help, and a paucity of contestant knowledge regarding how to best get off the drug. If they can! LOL See contestant’s daily struggle to hang onto their sanity as they are assaulted by “the zaps,” vertigo, projectile vomiting, fainting spells, severe tinnitus, hypervivid nightmares, hallucinations, murderous headaches, tremors, chronic insomnia, heart palpitations, chest convulsions, severe and excruciating joint pain — and lots more! Withdrawees who manage to stave off suicide win an all expense paid trip to the U.K. to tour GSK’s world headquarters, followed by a bonus trip to Yugoslavia to meet with some of the survivors of Paxil’s early “dummied” clinical trials. And finally, any (surviving) contestants beset by withdrawal-induced PTSD or PANES are given a special “thank you for being such a trooper” plaque … presented in person by none other than GSK’s CEO J.P. Garnier himself. WOW!

*Note: The GlaxoSmithKline document displayed at the top of this page is authentic; it was first used in an ABC news expose in late 2004. See http://abcnews.go.com/Health/story?id=311956&page=1 for the story along with several other GSK confidential documents.

Visit The Paxil Protest for more….

http://www.thepaxilprotest.com/images/Paxil_Protest_web_site.pdf

GSK really cares about Africa…


http://nigerianobservernews.com/28062011/news/Other%20News/othernews%202.html

Glaxosmithkline to pay N1.2b as damages

LAGOS- A Federal High Court in Lagos yesterday ordered Glaxosmithkline Plc (GSK) to pay N1.2 billion to Continental Pharmaceutical Company (CPL) as damages for its trademark infringement.

Delivering judgment in the 16-year-old suit, Justice James Tsoho also awarded another N150,000 against GSK as exemplary cost after CPL claimed that they appeared about 50 times during the case.

Tsoho, however, refused to award CPL relief that sought a N1,000 per printed copy cost on the proceeds of the infringed trademarks prescribed under Section 20(1) of the Copyright Act.

He held that the plaintiff’s 40551 trade mark and device was valid and subsisting and, therefore, the defendants infringed on the plaintiff’s trademark.

“The defendants illegally adopted the plaintiff’s trademark to deceive the buying public in an attempt to pass out their Panadol as the plaintiff’s product,’’ he said.

The judge held that the defendants’ submissions were inconsistent, adding that “ it was wrong for the defendants to assume that the ownership of copyright between an employee and employer can be the same’’.

Also joined in the suit were the Glaxosmithkline Consumer Nigeria Plc, Smithkline Beecham Plc and Glaxogroup Ltd.

The plaintiff, (CPL) had in the suit urged the court to declare that in its registered trademark, RTM 40551, was valid and subsisting and had been infringed by the defendants.

CPL also sought the relief of N1 billion as special damages against the defendants jointly and severally for infringement of the copyright in the artistic work of the registered trademark.

It had also wanted the court to award to CPL N1,000 per infringing packet (copy) under Section 18 of the Copyright Act, Cap 68, Laws of the Federation of Nigeria 1990.

But the defendants in their defence denied infringing on the trade mark right of the plaintiff.

They contended that the trademark Panadol was registered in Nigeria as N0 8785 in Class 3, which meant that it was a word mark without a device or logo.

When GSK Cock Up… They Do It Spectacularly …


The following are a series of articles regarding GSK monetary legal settlements in various states across the US. Basically GSK were producing shoddy quality drugs in their Puerto Rican manufacturing plant, they were caught by a whistleblower and these fines came as a result. Some of the drugs got mixed up, including Paxil (Seroxat). Heart medications were mixed with Anti-depressants and all sorts of shenanigans ensued. Will we ever know how many people were harmed because of this almighty Cock Up by GSK?…

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml

Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says.

http://www.fiercepharma.com/story/gsk-whistleblower-details-cidra-plant-woes/2011-01-03

http://www.guardian.co.uk/business/2010/oct/27/glaxosmithkline-whistleblower-awarded-96m-payout

A whistleblower who exposed serious contamination problems at GlaxoSmithKline’s (GSK) pharmaceutical manufacturing operations has been awarded $96m (£60m).

Cheryl Eckard’s payment is thought to be the biggest ever handed to a US whistleblower. It was awarded after an eight-year fight, which ended yesterday, when GSK agreed to pay the US government $750m to settle civil and criminal charges that it manufactured and sold adulterated drug products.

Speaking outside the federal courthouse in Boston after the award was agreed, Eckard admitted she was “a little emotional”.

“It’s difficult to survive this financially, emotionally, you lose all your friends, because all your friends are people you have at work,” she said. “You really do have to understand that it’s a very difficult process but very well worth it.”

The case centred on a factory in Cidra, Puerto Rico, where GSK made a range of products including an antibiotic ointment for babies, and drugs to treat nausea, depression and diabetes. In August 2002, Eckard, a global quality assurance manager, led a team sent to the plant to investigate manufacturing violations that had been identified by the US Federal Drugs Administration (FDA). Eckard lost her job nine months later after warning that the problems ran deeper than the FDA realised.

Eckard’s lawyers, Getnick & Getnick, said she was made redundant against her will in May 2003 after repeatedly complaining to GSK’s management that some drugs made at Cidra were being produced in a non-sterile environment, that the factory’s water system was contaminated with micro-organisms, and that other medicines were being made in the wrong doses.

“Cheryl Eckard is a role model for whistleblowers,” said Lesley Ann Skillen, a partner at Getnick.

Carmen Ortiz, US attorney for Massachusetts, said the case should serve as a warning to other pharmaceutical companies. “We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society,” Ortiz told a press conference last night.

Eckard tried to alert GSK’s management to the situation in Cidra even after she left the company. According to the lawsuit brought by Eckard, she tried to call GSK’s chief executive JP Garnier in July 2003, but he declined to speak to her. She took her concerns to the FDA in August 2003 after concluding that GSK’s compliance department lacked the authority to address her concerns.

Getnick & Getnick said the case was particularly significant because it was so difficult for patients to spot deficiencies with medicines.

“Once the pill is swallowed, it’s gone and there may be no way of telling whether someone got sick because the product was bad. As a result of this settlement and guilty plea, drugmakers will now have more reason to live up to their motto that patient safety is their first priority,” Skillen said.

The Cidra factory had been GSK’s largest manufacturing operation but was closed last year. Drugs made at the plant include Bactroban ointment, a topical antibiotic used to treat skin infections in babies, Kytril, an anti-nausea drug used by cancer patients, anti-depressant treatment Paxil CR and Avandamet, a derivative of the diabetes drug Avandia.

GSK announced in July that it would pay $750m to settle the charges, and the details were finally agreed on Tuesday in Boston. It will pay fines totalling $150m, plus related claims of $600m.

GSK said that it had worked hard to resolve the problems at Cidra, adding that it has not received any warnings from the FDA since 2002.

“We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice requirements and with GSK’s commitment to manufacturing quality,” said PD Villarreal, GSK’s senior vice-president and head of global litigation.

Eckard’s lawsuit was filed under the False Claims Act, legislation that dates back to the days of Abraham Lincoln. It is designed to allow private citizens with knowledge of fraud on the government to sue and share in the proceeds of the recovery.

http://www.citizen-times.com/article/20110630/NEWS/306300046/Glaxo-agrees-40-75-million-national-settlement?odyssey=mod%7Cnewswell%7Ctext%7CFrontpage%7Cp

Glaxo agrees to $40.75 million national settlement

RALEIGH — Drug makers GlaxoSmithKline and SB Pharmco Puerto Rico have agreed to pay $40.75 million to 38 states including $1.2 million to North Carolina, Attorney General Roy Cooper announced.

“Consumers depend on medication to be safe and reliable, and quality manufacturing is key,” Cooper said.

The settlement resolves allegations that GSK and SB Pharmco used substandard manufacturing processes when making certain drugs at a plant in Cidra, Puerto Rico. Cooper and the other attorneys general contend that the drug companies engaged in unfair and deceptive practices when they manufactured and distributed medications that did not meet standards for quality and purity.

The drugs manufactured at the Cidra plant were: Kytril (used to prevent nausea and vomiting caused by cancer treatment); Bactroban (an antibiotic ointment used to treat skin infections); Paxil CR (the controlled release version of the popular antidepressant drug, Paxil); and Avandamet (used to treat Type II diabetes).

GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009. All adulterated batches of the drugs covered by this agreement were recalled years ago and/or their expiration date has past, so there is no reason for consumers currently taking these medications to be concerned.

GSK and SB Pharmco are barred by today’s settlement from making false, misleading or deceptive claims regarding the manufacturing of the drugs at issue, regardless of where they are now produced. In addition, the companies must not misrepresent the drugs’ characteristics, or create confusion or misunderstanding about the way in which they are manufactured.

Earlier this year, North Carolina recovered $11.8 million as part of a $600 million national Medicaid fraud settlement involving similar claims against GSK.

Delaware to receive more than $550K in settlement with GSK

As part of a 38-state settlement, pharmaceutical giant GlaxoSmithKline (GSK) will pay $551,426 to the state of Delaware.
In a complaint filed last week, Attorneys General from 38 states assert GSK and SB Pharmco Puerto Rico (SB Pharmco) made deceptive claims about how four drugs were produced at their facility in Cidra, Puerto Rico.
“It was more centered on quality control and making sure that what they were producing was a product that was consistent with the chemical makeup of the drugs,” said Ian McConnel, Director of the Delaware Department of Justice’s Fraud Division.
The drugs in question: Kytril, a sterile drug used to prevent nausea and vomiting caused by chemotherapy and radiation cancer treatments; Bactroban, a topical antibiotic ointment used to treat skin infections; Paxil CR, a controlled-release form of the antidepressant medication Paxil; and Avandamet, a combination Type II diabetes drug. Delaware Attorney General Beau Biden blames substandard manufacturing processes for the drugs’ compromised makeup.
“Pharmaceutical manufacturers have a responsibility to produce drugs that are safe and generated according to strict guidelines,” said Attorney General Biden.
Biden announced Tuesday, the $550-thousand award will be deposited into the state’s Consumer Protection Fund and added this settlement resolves the allegations of substandard manufacturing practices against GSK.
“We hold drug companies to a high standard because that’s what consumers and their families deserve,” said Biden.
The Cidra facility shut down in 2009 and the Department of Justice says consumers need not worry since the drugs in question were recalled many years ago and/or have passed their expiration dates.
« More from Delaware

GSK, The MHRA, Dr Benbow and Bob Fiddaman


Bob Fiddaman has been rattling the cages of GSK and the MHRA for years now. An admirably dedicated and relentless blogger, Bob’s work has been recognized as some of the best human rights activism around. In his latest post about Dr Benbow, he publishes a response from the MHRA under a FOI request. As usual, the MHRA do not fail to disappoint when it comes to revealing information about Seroxat… The MHRA, true to their motto : “Safe Guarding Pharma Wealth”

http://fiddaman.blogspot.com/2011/06/mhra-on-gsks-dr-alastair-benbow.html

From: fiddaman robert
Sent: 25 June 2011 13:08
To: MHRA Central Enquiry Point
Subject: FOI Request

– Show quoted text –

MHRA Information Centre

The following request I make under the Freedom of Information Act.

To whom it may concern,

1. In a 2002 interview with BBC TV’s Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed that, “… the majority of patients who experience withdrawal symptoms – and the majority of patients actually do not experience any withdrawal symptoms – of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks.” He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like the MHRA to provide me with the study/studies that substantiate Dr Benbow’s claim.

2. Furthermore, in the same interview, Dr Benbow claimed, “maybe that a small proportion of patients do get more severe symptoms…”. Under the FOIA I would like the MHRA to provide me with the study/studies that substantiate Dr Benbow’s claim.

The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.
We cannot give you a definitive answer, we would advise you to contact GSK directly to ascertain what studies Mr Benbow considered supported his statement. Any studies he may have considered should have been published on our website. You may wish to review the SSRI Expert Working Group report published on our website (link below), the report outlines all the data the Agency has considered in relation to the issue of withdrawal reactions with Paroxetine.

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON1004259

The Agency has previously released relevant data that has been submitted to us with regards to withdrawal reactions and also data submitted to us by GSK in the context of this review and the European Article 31 referral, which is also available on the GSK website.

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

I sent the same FOI to GlaxoSmithKline – they never even bothered to acknowledge receipt of it.

Transparent as ever!

Fid

______________________________

As you can see, the MHRA clearly don’t give a flying Fiddler about the Seroxat Scandal and the hundreds of thousands affected …
Typical…

GSK: Opportunistic Cynical Vultures?


Of all the bad deeds of GSK over the years, one that I find the most cynical and sinister is their exploitation of the aftermath of the 9-11 twin towers terrorist attack in New York. GSK blitzed the American media with adverts for Paxil after 9-11 because they knew that many Americans would be depressed and anxious because of the trauma of it. This opportunistic and cynical campaign is a clear example of how pharmaceutical companies like GSK seek to capitalize on human misery, trauma and suffering.

http://www.naturalpedia.com/GlaxoSmithKline.html

“As part of an earlier campaign for “social anxiety disorder” (“Imagine Being Allergic to People” was the slogan), glaxosmithkline spent $92 million in one year to market Paxil—more than Nike spent to market its top shoes.100 The result of all this: Paxil passed Prozac and Zoloft and became the world’s ninth best-selling drug.101 The marketing has been so excessive that the drug companies clearly took advantage of the events of September 11 for sales. Even Psychiatric News, a journal of the American Psychiatric Association, said that drug makers like Glaxo found 9/11 “a marketing opportunity.”

– Charles Barber, Comfortably Numb: How Psychiatry Is Medicating a Nation (Get the book.)

http://seroxatsecrets.wordpress.com/2007/12/30/paxil-is-forever-can-you-quit/

Paxil was the first central-nervous-system drug to be advertised by name on television, according to Advertising Age. With such tag lines as “Your life is waiting” and “What if you were allergic to people?”, the spots targeted 18-to-34-year-old professionals.
In the weeks following the attack on the World Trade Center, Glaxo positioned Paxil as the perfect antidote to post-9/11 anxiety. “Your worst fears,” agonized one woman, seated at a kitchen table, “the what-ifs… I can’t control it.” “I’m always thinking something terrible is going to happen,” another woman fretted. “It’s like a tape in my mind,” a third confessed. “It just goes over and over and over.”

The GSK Corporate Blog: Tragically Ironic


GSK have had a corporate blog for a while now. The content is very bland. It’s mostly made up of stories and anecdotes clearly contrived for PR purposes. It is strictly moderated, which kind of defeats the purpose of social media and blogs, which are mostly created for the purpose of discussion on a topic. Last night one of their articles struck my eye and I feel I need to highlight the irony of it. In a recent post titled ” Bringing smiles: Bangladesh” , there is a picture of a baby indian child with a cleft lip. A cleft lip is a deformity of the lip, and this GSK blog post seems to intend to highlight the causes of a cleft lip and the charitable experience of a GSK employee with the Pulse program (A GSK funded initiative).

GSK fails to mention that their drug Seroxat can actually cause cleft lips in babies born to pregnant mothers who have ingested Seroxat during pregnancy. Ironic? … I think so.

MHRA update on the risks of birth defects in babies born to mothers taking paroxetine – Q&A

Q So, is it safe to take paroxetine during pregnancy?
We can’t say for certain. We don’t have much evidence on how safe it is to take many drugs during pregnancy. This is because testing drugs on pregnant women isn’t usually allowed.
We have sought advice on the safety of paroxetine from experts on the Commission on Human Medicines. The Commission on Human Medicines is an independent committee responsible for providing expert advice on drug safety. Based on the available evidence, the Commission considers the risk of birth defects appear to be small. But it agreed there is still a lot uncertainty around the risks of taking paroxetine when you’re pregnant.
What we do know is that most women who took paroxetine in the studies had a healthy baby.
Q What sort of birth defects did the babies have?
The babies affected mainly had heart defects, such as a hole in the heart (doctors call this ventricular septal defect). Sometimes the hole closes by itself, but some babies need surgery.
The study also found problems such as a cleft lip or palate (this is when parts of the mouth don’t grow together properly) and problems with the digestive system. For example, some babies were born with a narrowing of the lower part of the stomach, which makes them vomit forcefully (called pyloric stenosis) or with an anus that didn’t open properly. Babies with these problems usually need surgery.
There is a small risk of these problems even if you don’t take paroxetine when you are pregnant.

http://www.medscape.com/viewarticle/745430

More Evidence SSRIs in Pregnancy Boost Birth Defect Risk

From Medscape Medical News > Psychiatry
More Evidence SSRIs in Pregnancy Boost Birth Defect Risk
Megan Brooks
Authors and Disclosures
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June 28, 2011 — A study from Finland provides more evidence that exposure to selective serotonin reuptake inhibitors (SSRIs) in the first trimester of pregnancy increases the risk for major congenital anomalies, particularly cardiac defects.

In the study, use of fluoxetine in early pregnancy was associated with about a 2-fold increased risk for isolated ventricular septal defects, whereas paroxetine was associated with more than a 4-fold increased risk for right ventricular outflow tract defects.

Heli Malm, MD, PhD, from the Teratology Information Service, Helsinki University Central Hospital, Finland, and colleagues note the absolute risk for these specific cardiac anomalies is small — 0.5% and 0.2%, respectively, “but should guide clinicians not to consider fluoxetine or paroxetine the first option” when prescribing an SSRI to women planning pregnancy.

Reached for independent comment, Christina Chambers, PhD, MPH, from the University of California, San Diego, who has also studied potential risks of SSRI use in pregnancy, said this paper confirms results of “several other papers showing small increased risks for selected specific birth defects, although not all previous studies have shown a risk.”

The study is published in the July issue of Obstetrics and Gynecology.

For the study, Dr. Malm and colleagues analyzed Finnish nationwide birth registry data covering 11 years (1996 – 2006). The cohort included 635,583 offspring, of whom 6976 (1.1%) had first-trimester exposure to SSRIs.

Overall, major congenital anomalies were not more common in SSRI-exposed offspring compared with unexposed offspring (adjusted odds ratio [OR], 1.08; 95% confidence interval [CI], 0.96 – 1.22).

For individual SSRIs, fluoxetine and paroxetine were associated with an increased risk for overall major congenital anomalies in the crude analysis, but the risk did not remain statistically significant after adjusting for confounding factors.

Table. Overall Major Congenital Anomalies in SSRI-Exposed Offspring

Exposed Offspring Crude OR (95% CI) Adjusted OR (95% CI)
Any SSRI (n = 6976) 1.24 (1.10 – 1.39) 1.08 (0.96 – 1.22)
Citalopram (n = 2799) 1.18 (0.98 – 1.43) 1.04 (0.86 – 1.25)
Fluoxetine (n = 1818) 1.30 (1.04 – 1.62) 1.16 (0.93 – 1.45)
Paroxetine (n = 968) 1.39 (1.03 – 1.86) 1.22 (0.91 – 1.64)
Sertraline (n = 869) 1.17 (0.84 – 1.64) 1.00 (0.71 – 1.39)
Escitalopram (n = 441) 1.09 (0.67 – 1.77) 0.84 (0.52 – 1.37)
Fluvoxamine (n = 240) 0.81 (0.38 – 1.73) 0.71 (0.34 – 1.51)
CI = confidence interval; OR = odds ratio; SSRI = selective serotonin reuptake inhibitor

True Association

SSRI-exposed infants were at greater risk for major cardiovascular anomalies in the crude analysis (OR, 1.29), but the risk did not remain significant after adjusting for confounders (adjusted OR, 1.09; 95% CI, 0.90 – 1.32).

For individual SSRIs, exposure to fluoxetine in early pregnancy was significantly associated with an increased risk for overall cardiovascular anomalies in the crude analysis (OR, 1.58; 95% CI, 1.14 – 2.19) and the adjusted analysis (adjusted OR, 1.40; 95% CI, 1.01 – 1.95).

In particular, fluoxetine was associated with an increased risk for isolated septal defects, even when excluding offspring needed care in the neonatal care unit (adjusted OR, 2.47; 95% CI, 1.50 – 4.07). This finding suggests a “true association between fluoxetine and ventricular septal defects,” the study authors write.

Early in utero exposure to paroxetine was associated with an increased risk for right ventricular outflow tract defects, but this was seen in only 3 cases with a wide CI (adjusted OR, 4.68; 95% CI, 1.48 – 14.74). However, the fact that 2 other studies found a similar association “gives additional strength to our findings,” the study authors say (Alwan et al. N Engl J Med. 2007;356:2684-2692 and Louik et al. N Engl J Med. 2007;356:2675-2683).

There was also a statistically significant association between citalopram and neural tube defects (adjusted OR, 2.46; 95% CI, 1.20 – 5.07). Two previous case-control studies have also suggested this link.

Dr. Malm and colleagues also observed that fetal alcohol spectrum disorders were nearly 10 times more common in SSRI-exposed offspring than in unexposed offspring (OR, 9.6; 95% CI, 4.6 – 20.0). Therefore, they advise that “special attention” be given to alcohol use in pregnancy women using SSRIs.

Chance Findings?

The researchers caution that they performed a “large number of comparisons” and “it is possible that some of the observed associations reflect variation by chance. Some of the associations were based on small numbers and could reflect random associations,” they add.

Still, they believe fluoxetine or paroxetine should probably not be a first option in women planning to become pregnant.

Dr. Chambers made the point that “no epidemiologic study can prove that there is a risk, but if there is one, it appears to be very low.”

Dr. Chambers’ 1996 report in the New England Journal of Medicine was the first to raise a red flag about adverse birth outcomes in pregnant women taking fluoxetine (Chambers et al. N Engl J Med. 1996;335:1010-1015). Since then several other reports have been published about the potential risks of SSRIs in pregnancy.

One of the more recent ones was a report published in BMJ in September, 2009 and reported by Medscape Medical News at that time.

This large, population-based cohort study linked SSRI use in early pregnancy with about a 2-fold increased risk for septal heart malformations in offspring. The risk with individual SSRIs varied and again the absolute risk was small.

Dr. Malm and colleagues note in their report that depression affects up to 20% of pregnant women and use of SSRIs during pregnancy is becoming more common. Direct teratogenicity for any of the SSRIs has not been established, they note.

The currently available evidence points to fluoxetine and paroxetine as the individual SSRIs “seriously suspected to cause marginally increased risk for congenital cardiovascular anomalies,” they write. The current study supports this link.

The study was funded by the Social Insurance Institution in Finland, the Finnish Medicines Agency, and the National Institute for Health and Welfare. The study authors have disclosed no relevant financial relationships.

SSRI ANTIDEPRESSANTS: THE BIGGEST CORPORATE SCAM


Woah..
I didn’t realize that SSRI blogging had become so widespread! ..

http://ssriscam.blogspot.com/

SSRI ANTIDEPRESSANTS: THE BIGGEST CORPORATE SCAM

SATURDAY, JANUARY 23, 2010

The evolution of the scam
In the 1970’s the pharma industry started research on a new class of drugs. It seems like humans sometimes get depressed and Pfizer saw an opportunity to cash in on our misery. They started experimenting with a class of drugs called serotonin reuptake inhibitors. Basically the goal was to manipulate the level of serotonin in the brain with the underlying idea that people with more serotonin were happier and less depressed, and those who had lower serotonin levels tended towards depression. The idea that serotonin is a hormone that controls your mood was the subject of one of the early studies that were the scientific basis for the later marketing bullshit after the introduction of Prozac, Paxil, et al. Simply put, a group of monkeys were observed for a period of time and it was determined which of the males were alpha males (they got the best food and the most females to mate) and the rest of the males (losers in the game of life.) Once that determination was made, the monkeys were killed and the level of serotonin was compared to the social ranking of each monkey. The research suggested that high levels of serotonin correlated with “success” and lower levels with “failure.” The alpha monkeys had higher serotonin levels. The first thing that pops into your head when you really think about it is of course there is no way to know what a monkey “feels” like. There is a great big assumption here that monkeys that are “successful” or “alpha” are somehow less depressed or happier than the other less blessed members of the troop. This is just scientific idiocy. After all, don’t we all know some humans that are rich and successful but also depressed and suicidal? Don’t we all know a few humans that are poor as a church mouse but as happy as a human can be? Of course we do. But then again, Big Pharma, and many therapists and doctors really don’t care how you “feel.” They just want you to be able to get up in the morning and go to work. If an antidepressant accomplishes that, then they call it good. Add to that the fact that the average doctor in the US was gifted $15,000 a year from Big Pharma all through the 80’s and 90’s and you can see why doctors are so enthusiastic in prescribing them. There is a deeper flaw in the original research though. It is the assumption that the hormone serotonin regulates mood. This is only an assumption with no evidence that it is true. It is my personal opinion that serotonin regulates social standing in the group, that is high serotonin will make a person behave more alpha (dominant and aggressive), and low serotonin will tend to make a person into one of the followers in the group. That is the only correlation that is provable by the monkey study. I am sure that big pharma was aware of this flaw, and that’s what makes SSRIs a scam. Which leads to another problem with SSRIs that has manifested itself in human society: SSRIs have been implicated in violence, mass murders and suicides. The killers at Columbine were taking SSRIs, and there is a very long list of other killers who have been taking this crap when they went over the edge. Well think about it! Take a troop of monkeys with a few alpha males, some adult females, and some males who are peripheral followers. We may think that the alpha males are happy and the followers are miserable, but how would we know? Now put all the “unhappy” peripheral males on an SSRI regimen to ease their “depression.” If serotonin is as I believe a hormone regulator of social status and not mood, what you have done is create a troop of monkeys that are all alpha males! This is a recipe for violence, aggression, and the breakdown of monkey society. Don’t we see the same thing in human society? The evidence is overwhelming that SSRIs produce violence and aggressive behavior in humans, at least some of them. How can this be if an SSRI is nothing but a benign antidepressant, a mood elevator? The answer is that people who take SSRIs start believing that they are the leader of the pack, to varying degrees. This is also a recipe for disaster. When everyone imagines himself to be a leader there will be no peace. Chemically most SSRIs have a component phenylalkylamine that is the same chemical found in mescaline and amphetamine. For this reason, and for the reasons above, I call the SSRI’s “designer speed.” SSRI’s are basically a timed release version of methamphetamine. SSRIs are addictive. There are two obvious proofs of the addictive qualities of SSRIs. The first is the fact that people often build up tolerances to the drugs, and the dosage must be increased. Your doctor will look you in the eye and tell you that you must “titrate up” your dose. On the street, drug addicts call this process something else. The second proof is the heavy, serious withdrawal symptoms experienced by many who try to quit an SSRI. These withdrawals are so serious that the Pharma companies themselves strongly urge people to taper down from the drug rather that quit cold turkey. When your doctor hands you a free month supply of Paxil or Prozac he is hooking you on a drug, and it is an expensive drug. Remember that. There have been countless studies since the monkey study of course , mostly financed by Big Pharma, but there is overwhelming evidence that the studies publicized by Big Pharma have been cherry picked, it has been proven in court. And there was a study just a few years ago, a meta analysis of hundreds of large studies, that proved there is really only one factor in improving the life of someone who is really depressed. That is the “alliance effect” which refers to the situation where you have a therapist that you like and who you trust, and who you believe is working in your interest. Nothing else really matters, not SSRIs or older antidepressants, not therapy technique like CBT, nothing. So if you are seriously depressed find a therapist who will talk to you, and if you are lucky you will find one who really cares. Most of the studies done in the last twenty years are of short duration 8-12 weeks or so, and most of the ones published by big pharma indicate that the pills helped people who were somewhat depressed, but did very little for people who were chronically or deeply depressed. The reason for this is simple: take 100 people who say they are depressed. Maybe 75 to 80 % of them will get out of their funk with or with out the drug. Swings in mood are normal, but they don’t usually last more than a few weeks. You give someone your faux medication, full on in the knowledge that the patient will get better anyway whether he takes it or not. This is fraud on a grand scale, Big Pharma is the perpetrator abetted by a greedy and gullible medical establishment. My advice for you, if you are depressed, before you consider this big pharma crap, is go for a walk every day, talk to interesting people, and turn off your television. Give it a try. have a peaceful day

Goodbye to SSRIs: my Paxil weaning journey


Paxil is the American and Canadian brand name for Seroxat.

A journal chronicling one woman’s journey to wean herself off of SSRIs after 5 years of use.

http://goodbyessri.blogspot.com/

PAROXETINE ADDICT : PAXIL, SEROXAT, PAROXETINE ADDICT ON A JOURNEY TO THE STARS


Interesting new Blog documenting a users experience of Paroxetine..

Paroxetine is the chemical name for Seroxat (Paxil-Aropax).

Check it out:

http://paroxetineaddict.blogspot.com/

Blogging : A Force To Be Reckoned With: Yet Another SSRI Blog Appears…


They just keep popping up.
Great to see more people writing about their own experiences of the truly dreadful SSRI drugs.
Solidarity People…

Dangers of Antidepressant Drugs
Opinions and comments on Antidepressant Drugs, the negative and potentially life threatening side effects as experienced by people around the world. Discuss your thoughts, points of view or experience with these medications. Find information on SSRI Antidepressant Drugs, read about how peoples lives have been changed and even ended by these little pills. Post your own concerns and see what others think. Meet new people, see multiple sides to every story, and add your own input.

About Me
Name:
br8k-4life
Location:
Ontario, Canada
I have created this site in hopes of saving just one person from the terrible side effects some people have with these drugs. I speak from a personal experience that has caused me to lose my family and freedom. While my future is still on clear and I still face further destruction to my life as a result I am trying to help others while I can from these life treating and devastating effects. I cannot stress enough these dangers. Please, if you are on these medications or a loved one is, please read these articles and watch for any signs.

http://theworldasweseeit.blogspot.com

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