Monsanto Roundup Lawsuit


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

Monday, July 30, 2012

Glaxo's Lucozade Sport Fails Miserably





GlaxoSmithKline came under fire again…from BBC investigative reporter, Shelley Jofre, [again]
No mentions of their illegal promotion of antidepressant medication to children in this particular expose by the Scots ankle-biter Jofre, this piece was about their boasts and claims of their popular “energy” drink, Lucozade Sport. ‘Claims’ being the operative word here because that’s all they have, no science just trumped up claims aimed at you, the consumer.

I’ve not heard any stories [yet] of Lucozade inducing suicide or causing addiction, unlike Glaxo’s top selling antidepressant Seroxat [Paxil].  What we do know about Lucozade Sport is that one single bottle contains up to 8 spoonfuls of sugar.

What I find ironic is that GlaxoSmithKline are heavily involved with the dope-testing of athletes at the current Olympic games going on in London. Judging by the findings of Jofre, Glaxo should be getting their own house in order before weeding out the Olympic cheats.

A research team at Oxford University wanted to find out if Glaxo’s Lucozade Sport really did what it said on the bottle and in the multi-million pound advertising campaign seen in magazines, billboards and TV commercials up and down the UK. Their findings shouldn’t shock anyone who knows this company and their history of spinning clinical data.

Glaxo being Glaxo sent the research team over 80 studies that apparently proved that Lucozade Sport delivered the goods, goods such as drinking it makes you last longer and finish stronger - Ooh er missus, sounds like a tagline from a Carry On movie. [Insert Sid James laugh here]

The team sifted through the documents with 3 main criteria:

Quality of evidence
Size of effect
Who does it apply to?

What they found was that the quality of evidence was poor, the size of effect was miniscule and that Glaxo’s claims didn’t apply to the population at large who were buying Lucozade Sport. In other words Lucozade Sport has no impact on performance for ordinary people.

Are you surprised?

Back in 2010 I wrote about the hyperactivity link in Lucozade, a number of other suspect food colourings were found in Lucozade after a study by Southampton University, commissioned by the Food Standards Agency, identified 'psychological harm' caused by the additives.

Back then Glaxo were finding it difficult to find a replacement for the colouring agent Sunset Yellow, which is among a number of suspect food additives and also used in Lucozade. Instead, they opted to put a warning on the bottles:

'Sunset Yellow may have an adverse effect on activity and attention in children'.

Children again eh.

Déjà vu anyone?

Anyway, I  digress [slightly]… the Panorama programme, aired in the UK, isn’t available for view here in NZ so I downloaded it for my viewing pleasure.

The programme, ‘The Truth About Sports Products’, was aired on BBC TV July 19th and can be watched  here [UK only]

This latest exposure comes on the back of a $3 billion settlement fee to the US government which saw Glaxo plead guilty to a number of illegal promotional activities with prescription drugs. Their CEO, Andrew Witty, claimed [there's that word again] that it was all part of an era, suggesting that illegal promoting and falsifying data doesn't exist any more at Glaxo. Hmm, okay Andy, we believe you.

GSK were given the heads up of the BBC broadcast and released a pre-statement that was full of the usual denials, lines such as, "Lucozade Sport and the Maxinutrition range have become leading sports nutrition products and play a valued role in the active lives of millions of people in the UK." and "The evidence supporting the performance benefits of carbohydrate-electrolyte drinks such as Lucozade Sport is strong", and the classic, "We take our responsibilities to consumers very seriously..."


Oh well, at least they didn't blame an era.

Jofre, once again, highlighted Glaxo's desire to spin data - I doubt if she is on their Christmas card list... I doubt if she gives a hoot.





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Friday, July 27, 2012

Greg Thorpe GSK Whistleblower and the 'Dark Knight'

GSK's Andrew Witty. What was his role in 1997/98?



One of the recent UK GSK whistleblowers, Greg Thorpe, is letting off some steam on a UK newspaper website.

I'm trying to reach out to Greg for an interview for this blog. He, it appears, has much to say about Sir Andrew Witty, CEO of GlaxoSmithKline, in the comment section of the Yorkshire Post article, "Glaxo admits ‘mistakes’ over US guilt"

Just in case Glaxo's highly paid lawyers feel the need to put pressure on the Yorkshire Post, I have added Greg's comments below:


Someone over there ask Sir Witty, VP in marketing at the same time, app. 1997-2000, what his role was in all this blood money. He calls it echoes of the past, another era, another company yet he was there. Did he participate ? Did he know ? What did he know ? Why did he not come forward ? Why won't he answer these questions, seems logical....whether he was involved or not. I blew the whistle, I was tossed out after 24 years with the company.


I was terminated and retaliated against for the last 11 years. The law demands that GSK pay double back pay, reinstate me..or pay front pay, plus pay for the horrors they have put me and my family through for the last 10 plus years. GSK covered up their conduct, got caught and now Witty is "sorry" ? Yes, actions speak louder than words.....this "changed" company, who should reward me for coming forward to them with the marketing schemes, now wish to use their "blood money", to deny me my rightful compensation. They took 11 years from me and my family suffered. I was blackballed in the pharmaceutical business. In the meantime Witty was "knighted". Well Sir Witty, now you are making me fight you in Court for what you owe me. GSK is huge, but you will not break me. So from now on, when you say you are sorry, tell the whole story, not just your filtered version. Appoint me as your compliance officer, I am well qualified....No GSK has not changed, they intend on shooting the real messenger that tried to change the company.....again. Nice try Sir Witty, tell the whole story the next chance you get...Sincerely Thorpe the "commoner".


----



Oh yes, and you Britts must read my Complaint, and see the exhibits, you can find it online...Thorpe v. GlaxoSmithKline.
Quite the story...3 billion dollars, hmmmm.


----



Oh and Sir Witty, where does the buck stop, the charges went all the way until 2010, You were CEO , "ECHOES OF THE PAST ? '".....Then your thousands of attorneys, here in the states, threw Avandia into the settlement.Nobody knows how many thousands died from that drug.


Avandia killed my own mother, do you want her picture, her medical records, or maybe some of her ashes, a reminder every day that when you hide clinical data, someone dies.....she is one of thousands. Who is going to jail ....any recommendations, SIR Witty ?


Your attorneys sneaked that drug into the settlement without my knowledge. A scam period, my own mothers life was worth a thousand times the small amount you paid on that. You are "sorry", well maybe a little hard time in a U.S. prison would clear your conscience. I am sure your cellmate, BUBBA will turn your "knighthood" into the "knightmare", your changed squeaky clean company, GSK deserves. A knight ? Please.


----

Back story about GSK's Knight HERE.

Greg, if you are reading... let's Skype.








Saturday, July 21, 2012

Sara Carlin: She Would Have Been 24




Happy Birthday Sara Carlin.

24 today.

It's a cruel world when a life so precious is taken away. So many young lives lost to pharmaceutical companies and their lust for power, lies and greed.

Nessun Dorma, Sara.





Back stories HERE




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Friday, July 20, 2012

GSK - Power Corrupts and Absolute Power Corrupts Absolutely




A visual testimony to the saying of 'power corrupts and absolute power corrupts absolutely' - the mindset of these corporations has to change in order for the behaviour to change this will not happen if examples of honourable behaviour are not shown at the top.

Where once bad practice, deception, manipulation etc were considered disgraceful, and sackable offences, we now have such practice built into management programmes as the norm!

GSK, from the bottom to the top, you are a disgrace.

The Devil is in the detail.








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Wednesday, July 18, 2012

GSK's Olympic Boast




A mixture of emotions after watching GSK's promotional video for their anti-doping service they are offering for the London Olympics.

GSK were given the task to test athletes by the World Anti Doping Agency [WADA]. Of all the pharmaceutical companies in the world and they choose one with an abysmal track record of safeguarding human health!

The opening lines of the narration in the promo video had me reaching for the vomit bag.

"The aim is to protect athletes and stop doping in its tracks"


Protect?

This is the same company who were supposed to protect children from taking a drug [Paxil] that was meant for adults. Instead they had ghostwriters draw up an academic paper that claimed this adult drug was safe for kids...when in fact they knew all along that it wasn't.

It's also the same company who promoted the use of an asthma inhaler [Advair] to people with mild asthma when it was only indicated for people with severe asthma.

It's also the same company that pushed it's diabetes medication [Avandia] onto patients when it knew, all along, that the medication caused heart attacks.

It's also the same company that knew that expectant mothers taking it's drug [Paxil] may give birth to babies born with heart and skull defects.

It's also the same company that pushed a drug [Imitrex] for mild headaches and for use in children even though it was not indicated for both.

It's also the same company that hired thousands of guest speakers to promote its  anti-epileptic medication [Lamictal], many of whom were child neurologists. In 2010 the FDA issued a warning that Lamictal use can cause aseptic meningitis, an illness characterized by serous inflammation of the linings of the brain.

It's also the same company that advertised its antibacterial agent [Raxar] as being safe and effective until it was withdrawn from the market in 1999 for causing Prolonged QT interval. Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients.

It's the same company that paid out a $7 million dollar settlement to the remaining members of a family after it was found that an antidepressant [Paxil] caused a loving father to take a .22 calibre pistol and a 357 magnum and, in the middle of the night, shoot dead the three people in the world dearest to him.

It's the same company that have settled over 3,000 cases with consumers who complained that they had extreme difficulties in withdrawing from its antidepressant [Paxil]

The same company that recently paid out a staggering three billion dollars to the US government for promoting its best-selling antidepressants [Paxil and Wellbutrin] for unapproved uses and failing to report safety data about its top diabetes drug [Avandia]

Its the same company who are currently fighting a lawsuit in the UK regarding it's antidepressant [Seroxat, known as Paxil in the US] whereby it refuses to accept any liability that consumers taking it had difficulty withdrawing from it. This, despite settling the same type of withdrawal cases in the US.

GlaxoSmithKline are a British based company. They are flying the Union Jack for Britain during the Olympics.

The watching world must be so proud that Britain are being represented by such a prestigious, forthright and morally ethical company.

Here's the promo video.





...and here's one more... just for balance.






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Sunday, July 15, 2012

Have You Had Enough Glaxo or do You Want Some More?




If paying out over $3 billion in fines for their scandalous behaviour and disregard for patients, GlaxoSmithKline, the British company that claim to help people do more, feel better and live longer, find themselves under the spotlight again with yet more offences and disregard for human health.

Forbes are reporting that two leading US attorneys, Michael Baum [Baum, Hedlund, Aristei & Goldman, P.C.] and Sean Tracey [Tracey Law Firm] have more irons in the fire where Glaxo are concerned.

The Forbes article, 'GlaxoSmithKline's $3 Billion Hit: Deterrent or Business Expense?' throws out some interesting observations regarding Glaxo's recent guilty plea over it's off-label promotion of many of its best selling drugs.

Where this article, penned by Rob Waters, excels more than most I've read is that it gathers the opinion of a former Paxil user and two US leading attorneys. A pseudonym, given to the former Paxil user because she wishes to remain anonymous, writes, “I think it’s despicable what they did and I think a $3 billion fine is pathetic,” adding,  “No specific individual executive has been prosecuted or punished or fined; there’s nothing to take away the incentives for huge drug companies to commit fraud. I’m infuriated.”

She's right and kudos must go to the author of this piece for allowing someone to voice their opinion who knows exactly what it feels like to be on the brink of suicide caused by Glaxo's drug, Paxil.

Baum goes further...

“Their admissions in the plea agreement and the information puts GSK’s experts and corporate representatives in a corner,” adding, “It makes it difficult for them to say they did not hide information from physicians.”

Both Baum and Tracey are well equipped when it comes to litigation against Glaxo. In 2001 Baum Hedlund represented more than 3,000 people across the United States in personal injury cases against GSK. More recently, The Tracey Law Firm were successful in showing a jury how Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. Lyam Kilker was born with heart defects, his mother took Paxil during her pregnancy.

More To Come

Glaxo, it appears, are desperately trying to keep Avandia documents under lock and key. “They’re fighting us on releasing these documents that show what really happened. They should allow the press and the public to see them,” Baum told Forbes.

Tracey added to the Glaxo onslaught with, “If pharma companies can flout the law and then simply write a check when they get caught, they’re never going to stop. “The money is too large. Until and unless someone’s liberty comes to jeopardy, they simply consider this the cost of doing business.”

They're right.

Glaxo have had their behinds kicked severely by Michael Baum and Sean Tracey. One would think that they would have learned their lesson. But Glaxo being Glaxo will continue to suppress which is why their CEO's recent statement on the $3 billion settlement is more laughable today than it was when he and his company first released it.

Witty blamed an era of GlaxoSmithKline, kind of a perverse comment considering he played a major role in marketing Glaxo's products during that era.

Both Baum and Tracey continue to seek damages for children born with heart defects as a result of their mothers ingesting antidepressant medication. Today, Pfizer are on their radar, more specifically their product, Zoloft [known as Lustral in the UK] Baum Hedlund have over 400 Zoloft birth defect cases and The Tracey Law Firm are representing another 150 clients.

Meanwhile, in the UK, the Legal Services Commission [LSC] have been presented with evidences to extend further the funding for the Seroxat litigation. A decision by the LSC is imminent.


According to the British drug regulator's yellow card reporting system there have been 33,142 reports of reactions to patients when taking Seroxat, 10,597 have been adverse reactions whilst there have been 178 reported deaths in the UK related to Seroxat.


The drug remains on the market and Glaxo have no intention of settling the UK litigation.


I'm glad they don't want to. I can't wait to talk about this particular case... and I will once it's over... regardless of the outcome.


When I grow up I want to become a lawyer - Bob Fiddaman 47





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Tuesday, July 10, 2012

GlaxoSmithKline: The Andrew Witty "Era"


GSK's Andrew Witty. What was his role in 1997/98?



First off let's take a look at Andrew Witty's statement that came on the back of his company pleading guilty to violations over a number of its drugs.



“Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.

“We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.
 “In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management. 
 “We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.”
All seems 'sweet' until we delve deep into Andrew Witty's tenure at Glaxo Wellcome and GlaxoSmithKline.

Glaxo's PR Department must have been hard at work these past few months or so. Searching for Witty's previous roles at the company have been exhausting. His bio page on the GlaxoSmithKline page doesn't really tell us anything about him at all, particularly between the years of 1997 and 1998 when he was head of the Glaxo Wellcome marketing team. One would think that winning an award for his marketing achievements during this period would sit proudly on any person's bio or CV...not Andrew Witty's though. Maybe it's a past that he would rather forget about or maybe his recent statement [above] would seem utterly ridiculous given that he himself was part of the problem [era]


1997/98 is a period of time where Witty was heavily involved in marketing although there are very few articles left on the internet that show this.


Glaxo Wellcome'sVP-General Manager of Marketing Andrew Witty, as he was known between 1997/98, worked very closely with prescription drug ads on TV. This is known as DTC or Direct to Consumer advertising.


In August 1997 the US Food and Drug Administration [FDA] relaxed its rules on DTC, it basically meant that the FDA were giving carte blanche to the pharmaceutical industry whereby they could promote their products in TV ads without giving detailed medical information on the indications, potential side effects, or proper use. [1]


Witty was quick to pounce. Why wouldn't he? DTC is lucrative for the pharmaceutical industry, well, it is in America and New Zealand as these are the only two countries that allow TV ads for prescription medication.


Witty added more products in 1997 with Glaxo's new anti-smoking pill Zyban, [buproprion] which got an estimated $55 million in support (the brand is even got TV teaser ads prior to its launch)


For those who don't know, Zyban is also in fact Wellbutrin which is an antidepressant that Glaxo marketed off-label for a whole host of reasons that it was never indicated for. See back story here and it will show you how Glaxo hired a famous radio personality to promote Wellbutrin for  increasing someone's orgasmic potential.


If we use the generic name, buproprion, rather than the brand names it gets slightly easier to follow.


You see bupropion is used to treat major depressive disorder and seasonal affective disorder and it is also used to help people stop smoking by reducing cravings and other withdrawal effects.


So, in 1997, Witty pushed Zyban, Wellbutrin, call it what you will, onto the TV screens and into the homes of millions of Americans. He was in actual fact pushing an antidepressant onto an unsuspecting public.


Here's a Zyban ad from 1997, this is one that Witty would have been behind as Glaxo Wellcome'sVP-General Manager of Marketing. What I find remarkable about this ad is that they do not distinguish the two brand names as being practically the same. The only warning they off is, "Don't take Zyban if you are taking Wellbutrin" - Surely it would have been morally ethical to tell the consumer, "If you take Zyban and Wellbutrin together you will actually be overdosing on the active ingredient, bupropion." But hey, why would a pharmaceutical company, like Glaxo, wish to inform its consumers that a drug that could help you quit smoking was  really an antidepressant?





Of course Glaxo got around this by altering the molecule structure. Change a molecule here and there and it can give you a whole new brand name with an even bigger target audience, case in point being Celexa and Lexapro, Forest pharmaceuticals blockbuster antidepressants, they are pretty much the same, save for a bit of laboratory tweaking.

So, with Witty's marketing strategy he and his team launched Zyban.


Are we to believe that Witty had no input to the sales team? Remember his statement at the top of this post?


"Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."


We?


A number of other drugs mentioned in the whistleblower suit seem to have fallen on deaf ears in the mainstream media. Lotronex,[alosetron] a drug made by Glaxo Wellcome that was on the US market for nine months, during which time it netted them an estimated $56 million. 


Why was it taken off the market?


According to Wikipedia alosetron was withdrawn in 2000 following the association of alosetron with serious life-threatening gastrointestinal adverse effects. The cumulative incidence of ischaemic colitis was 2 in 1000, while serious complications arising from constipation (obstruction, perforation, impaction, toxic megacolon, secondary colonic ischaemia, death) was 1 in 1000. 


This from The Lancet [2]



By July, 2000, concerns about the balance of risk and benefit were being voiced.3 Between February and June that year, seven patients had developed serious complications of constipation, three of whom required surgery. Eight further cases of ischaemic colitis were reported. The FDA had an opportunity then to take stock of its earlier decision. The clinical data confirmed the substantial and potentially life-threatening risks hinted at during pre-approval review. But instead of withdrawing Lotronex and calling for more evidence, the FDA issued a medication guide designed to warn patients of escalating risks, while keeping the drug on the market.
This decision was to prove fatal. On Nov 28, GlaxoWellcome withdrew Lotronex from the market after the deaths of five patients taking the drug. There had been 49 cases of ischaemic colitis and 21 of severe constipation, including instances of obstructed and ruptured bowel. In addition to the deaths, 34 patients had required admission to hospital and ten needed surgery. A letter from Janet Woodcock, director of CDER, declared that the "FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS". There was no word of sorrow or regret for the families of those who had died.

Strangely it was reintroduced to the market in 2002, although it carried warnings that were not put in place during the nine months it was previously on the market.


Although it can be said that Andrew Witty was not head of marketing during the Lotronex debacle he was, however, still Vice President - General Manager of Marketing of Glaxo Wellcome when their drug Raxar was pulled to task regarding violations of its marketing. Raxar wasn't mentioned in the whistleblower suit but it's worth mentioning because Witty was in charge of marketing during this specific time.


In 1997, Barbara Thompson, Assistant Director, Advertising Policy, FDA, wrote to Glaxo Wellcome. She told them that, after reviewing the Raxar press release it was found to be in violation [Fig 1]



Fig 1
Raxar was withdrawn from the market in 1999 for causing Prolonged QT interval.

Witty would have been in charge during the advertising faux pas and quite possibly would have been behind the press release slated for violations by Barbara Thompson [above.]


Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients. [3]


Imitrex, a migraine product that was mentioned in the whistleblowwer suit, was approved by the FDA in 1992. Documents from the lawsuit showed how Glaxo had pushed Imitrex for mild headaches and for use in children even though it was not indicated for both.


Here's an Imitrex ad from the 1990's, it's not known if Andrew Witty was head of marketing during this particular TV ad.





Here's Glaxo's 'self test' they created with the National Headache Foundation.





Lamictal, [lamotrigine] yet another drug mentioned in the lawsuit, was FDA approved in 1994. Once again,  I think it safe to assume that any promotional push via the marketing team would have come from Witty, at least during the 1997/98 campaign.

During the promotional push for Lamictal, after Witty had moved on from his role of marketing, Glaxo hired speakers to 'big up' the drug. Documents from the whistleblower suit show 7 pages of paid speakers, many of which were child neurologists. 


In 2010 the FDA issued a warning that Lamictal use can cause aseptic meningitis, an illness characterized by serous inflammation of the linings of the brain.



Maybe Witty should come clean or maybe documents will one day surface that shows how he, as head of marketing, pushed the off-label promoting of drugs that he was in charge of. I'm sure there are lots of internal emails that haven't made the public domain... yet.


Are we really expected to believe that Andrew Witty is whiter than white and he never knew what was going on or, indeed, he never once promoted the use of drugs in people or illnesses that they were never indicated for?


I'm surprised no journalist has asked him these questions. I'd just love him to go on record and state that he has never promoted the use of any drug for off-label use either personally or by proxy to the 9,000 or so pharmaceutical reps Glaxo once had, a figure that has almost halved over the years. Nonetheless, there's approximately 9,000 potential whistleblowers who would know whether or not Andrew Witty is the shining knight in armour who has been left to stifle the stench of JP Garnier, Glaxo's former CEO.


The violations, which amount to a humongous lump of excrement, cannot all be left at the feet of Witty's predecessor, JP Garnier. Witty, himself, has to take some blame on a personal level. 


I've yet to see him do this.


Special thanks to the Truthman for digging out the 1997 article from The Advertising Age.



[1] Do Ads Really Drive Pharmaceuticai Sales? By Steven Findlay

[2] Lotronex and the FDA: A Fatal Erosion of Integrity - Volume 357, Number 9268, 19 May 2001
[3] RAXAR: Warning on Label Omits Deaths - LA Times, Fri, 02 Sep 2005





Back Stories:


GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint

Advair Launch 2001: GSK's “Myth of Mild” Campaign









Monday, July 09, 2012

Scum! - The GSK Video

Scum - Slang One, such as a person or an element of society, that is regarded as despicable or worthless.


Mark McGowan pretty much sums up the way a lot of people feel about GSK.





Back Stories:



GSK - The Company With Great Ethics


GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint

Advair Launch 2001: GSK's “Myth of Mild” Campaign




Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE


Advair Launch 2001: GSK's “Myth of Mild” Campaign



The Department of Justice website has uploaded video excerpts of GlaxoSmithKline's promotional push of Advair to its reps. The video excerpts, from Las Vegas, even show former Glaxo head, JP Garnier, get in on the act, relaying the message, “...it would be criminal to not put an asthmatic patient on Advair”. It's hard to know who or where this message originated from as 'JP', it seems, is quoting someone else.

Hmm, nice use of the word 'criminal', JP.

GSK's Advair is used to prevent asthma attacks, and to treat chronic obstructive pulmonary disease [COPD] and the recent whistleblower suit, that GSK plead guilty to and paid a record $3 billion in fines, shows how they aggressively marketed it with promotional 'get togethers' as shown in the video  excerpts [below]



The whistleblower filings in the US Courts also name senior managers at GlaxoSmithKline for aggressively urging sales of Advair for forms of asthma that it was not indicated for, such as mild intermittent attacks, such as the senior manager telling the audience in the video, "The clinical data that supports Advair, you know you gotta just ask the simple question...what patient with asthma is not appropriate for Advair?" [Video around the 2 minute mark] whilst another tells the audience, "...there are people in this room who are going to make an ungodly amount of money selling Advair."


According to documents Glaxo even launched a “Myth of Mild” asthma campaign, its sole purpose, it seems, to target sufferers of mild asthma, even though Advair was not indicated for patients who suffered with mild asthma.


All Glaxo reps needed to do was to tell the doctors prescribing it. 



Documents also reveal that in 2004 Chris Viehbacher, former head of US pharmaceuticals at GSK, told investors at a meeting in London, “The real opportunity for us with Advair is that we can now convince physicians that there is no such thing as mild or severe asthma.” 


Amazing isn't it? And there was me thinking that pharmaceutical companies invented illnesses, not dismissed them!


Viehbacher is now Chief Executive Officer at Sanofi.


GSK's CEO, Andrew Witty, said in a statement about the record payout that “Today brings to resolution difficult, long-standing matters for (Glaxo). Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of (Glaxo), I want to express our regret and reiterate that we have learnt from the mistakes that were made,” 


A different era?

In actual fact, and what the mainstream press seem to be missing here, is that Andrew Witty was the Vice President and General Manager of Marketing of Glaxo Wellcome Inc. [GlaxoWellcome and SmithKline Beecham merged in 2000 to become GlaxoSmithKline.] Some of his responsibilities included, strategy development, marketing execution and new product positioning. Witty and his team were awarded a Medical Marketing Association [MMA] award [Medical Marketer of the Year] in 1998. He also worked in the Company’s International New Products groups, both in the Respiratory and HIV/Infectious disease fields.

Two words - Marketing and Respiratory. Alarm bells anyone?


In a perverse twist of fate during Witty's rise to success he was actually a sales representative for the respiratory business!

I'm just left wondering if, whilst a rep for Glaxo, Witty offered incentives to doctors... or if he actually thought that was morally wrong. If he did then any talk of era's at GSK must land at his feet and the buck-passing blame game must stop.

Apart from Paxil [Seroxat] and Advair, GSK also violated the promotional terms of  Imitrex, Valtrex,  Lotronex and Lamictal.

GSK's corporate tagline is, "GlaxoSmithKline helps people to do more, feel better and live longer."

Can someone please hand me a vomit bag!

Related:

GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint




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Friday, July 06, 2012

Glaxo's Qui Tam Paxil Complaint

Is GSK boss, Andrew Witty, about to break his promise?



Just going through the complaint made by UNITED STATES OF AMERICA, et at, ex rel
GREGORY W. THORPE and BLAIR HAMRICK, Plaintiffs, Vs SMITH KLINE BEECHAM, INC., and GLAXOSMITHKLINE PLC d/b/a GLAXOSMITHKLINE, Defendants.


The Paxil section, page 18, is interesting to say the least, particularly sec 58.



58. However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.


Now, we've always known about Paxil's addictiveness and we've always heard Glaxo spokespersons deny this.

It would be interesting to see if any exhibits produced in the above case showed that Glaxo hid evidence that Paxil is highly addictive. It would certainly open the creaky door to the UK Seroxat litigation. Although the wheels seem to have grinded to a halt on the UK litigation, it is still live, despite misinformed individuals making statements that the case has collapsed.

Anyway, the full complaint against GSK can be downloaded here. The Paxil section reads as thus:


Paxil [Known as Seroxat in the UK]

Paxil (paroxetine hydrochloride) was initially approved by the FDA on December 29, 1992 for the treatment of Major Depressive Disorder in adults. Thereafter, the FDA approved the drug for other uses, however neither Paxil, nor its extended release formulation known as Paxil CR, has been approved for any use whatsoever in patients under the age of 18.

Nevertheless, GSK has aggressively promoted Paxil and Paxil CR as a safe and effective treatment for a litany of mental issues for children, including, depression, anxiety, ADHD, shyness, and bi polar disorder, among others.

GSK's off-label marketing for pediatric use was particularly egregious because GSK knew no later than November 1998 that Paxil was ineffective in this age group and, even worse, that depressed pediatric users of Paxil were up to three times more likely to commit suicide or engage in other self-harming conduct. GSK not only knew these seminal facts, but withheld its own clinical study data that proved them to be true from the medical community and the public to protect pediatric Paxil sales.

However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.

Finally, GSK aggressively promoted Paxil as safe and effective for use during pregnancy. This marketing scheme rivals the contemptibility of its pediatric scheme. GSK characterized Paxil as having treatment benefits that outweighed the risks, when in fact GSK knew the opposite to be true. GSK knew that the drug substantially increased the risk of severe congenital birth defects, particularly holes in the heart of the fetus. The drug is now also known to cause Persistent Pulmonary Hypertension of the Newborn. When information about Paxil's link to birth defects finally became public in December 2005, the FDA reclassified the drug as Category D. Category D classification is reserved for drugs with a proven link to birth defects when used during pregnancy.

Paxil is the only SSRI with a Category D designation. GSK's concealment of evidence of birth defects deprived physicians and expecting mothers of the ability to make informed choices about the risks of its use during pregnancy. Had GSK disclosed the truth, undoubtedly the use of Paxil during pregnancy would have been severely curbed, which is exactly what GSK endeavored to avoid. This is particularly true of off-label use of Paxil, where safer alternatives would have been available.


----


Andrew Witty, Glaxo's CEO on the $3 billion settlement made by his company:


"“Today brings to resolution difficult, long-standing matters for (Glaxo). Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of (Glaxo), I want to express our regret and reiterate that we have learnt from the mistakes that were made,” [LINK]

The UK Seroxat [Paxil] litigation is based upon withdrawal and that the claimants, in the litigation, had difficulty withdrawing from the Seroxat.

Now, I'm no Albert Einstein but I'd say that a drug being highly addictive would cause severe withdrawal problems, wouldn't you?

It will be interesting to see if Witty sticks to his word, more so to see if he and his company really have learnt from the mistakes that were made.

I'm assuming that they [GSK] and their lawyers, Addleshaw Goddard, won't be contesting the claims against them in the UK then?

A pig has just flown past my window... I'm sure it had a French accent.

Plus ça change, plus c'est la même chose.


GlaxoSmithKline are a British Company that have been successfully sued by American attorneys on numerous occasions.

With Glaxo's CEO being part of British Prime Minister's Business Advisory Committee and with the British Drug regulator, the MHRA, having two ex- Glaxo employees on their staff, is it any wonder that it's easier for the UK man/woman in the street to split an atom then it is to get justice from GlaxoSmithKline.


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Thursday, July 05, 2012

GlaxoSmithKline's Perverse Olympic Games






One of the most popular posts on this blog over the last month or so has been '2012 Olympics - Team Glaxo', a post I wrote almost a year ago. It's picked up quite a lot of hits as the games approach [approx 15,000]

With this in mind, and because of recent events, I've fired off a second email to the World Anti-Doping Agency [WADA] - For those of you that don't know, WADA last year announced that GlaxoSmithKline would be part of their team at this year's Olympics.

To be honest, Glaxo should resign from their position but then again the words 'honest' and 'Glaxo' just don't marry, do they?

Here's the email:


Dear Sir/Madam,


A short time ago I wrote you voicing my concerns regarding the decision to allow British pharmaceutical giants, GlaxoSmithKline, to gain a position within the World Anti-Doping Agency to investigate medicines that could having performance enhancing potential in sport.


For reasons unknown to me you decided not to reply.


Once again I must draw your attention to GlaxoSmithKline, although I am sure you are probably aware of the recent media events concerning them.


They have recently pleaded guilty to misdemeanors regarding unethical tactics used in promoting dangerous medicines to vulnerable populations, namely children. Glaxo's pharmaceutical reps were shown to be bribing doctors with lavish meals, cash payments, holidays and concert tickets which had the effect of increasing prescriptions of antidepressants to children...when the product/s were not indicated for children.


I once viewed the Olympic Games as a prestigious event, one where families gathered around TV sets to cheer on their heroes. 


I can no longer do that because of your affiliation with a party who have pleaded guilty to crimes against children.


Many children have suffered as a result of GlaxoSmithKline's aggressive marketing tactics, some, it has to be said, have died as a result of induced psychosis from Glaxo's antidepressant medication, those poor souls committed suicide, a known adverse reaction when given to children and adolescents.


As I stipulated, I am sure WADA is aware of recent events, probably embarrassed too?


I wrote an article back in July, 2011 when I first heard of GlaxoSmithKline teaming up with WADA. That post has been read by over 15,000 people, it continues to be read.


For your convenience I have added, at the foot of this email, some recent newspaper articles with regard to GlaxoSmithKline's abhorrent behavior.


My two questions to you are simple;


1. In light of recent events do you still believe that GlaxoSmithKline should be allowed to be associated with WADA and the Olympic Games?


2. Do you think it perverse to include a company as part of a team of drug investigators when that company, by its own admission, promote unsafe drugs to children?


I look forward to your response.


Yours sincerely


Bob Fiddaman


Glaxo in $3 Billion Settlement - Wall Street Journal - http://online.wsj.com/article/SB10001424052702304299704577502642401041730.html

Glaxo Agrees to Pay $3 Billion in Fraud Settlement - New York Times - http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

GlaxoSmithKline pays $3bn for illegally marketing depression drug - The Independent - http://www.independent.co.uk/news/business/news/glaxosmithkline-pays-3bn-for-illegally-marketing-depression-drug-7904555.html



Related stories from this blog:

GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises



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Wednesday, July 04, 2012

GlaxoSmithKline - Pinsky, Bradshaw and Promises

,
"Whilst these originate in a different era for the company, they cannot and will not be ignored."
Andrew Witty, Monday 02 July 2012


Documents released as part of a settlement between the Department of Justice and GlaxoSmithKline showed how the British drug maker hired the services of Dr. Drew Pinsky, a host of the radio show LoveLine.

The released documents reveal that Pinsky was paid over $100,000 in 1999 to promote the use of Glaxo's antidepressant Wellbutrin "in settings where it did not appear that Dr. Pinsky was speaking for GSK."


True to his word...ahem contract... Pinsky, according to court transcripts, delivered.

On May 22, 1999, Pinsky appeared on the David Essel Alive radio program. Before being introduced the show's listeners heard a woman phone-in to speak about how she had become "super multiple orgasmic", she told listeners, "...it doesn't seem that possible to me to have that many, we're talking, I counted 60 one night."


The show's host, David Essel, seemed amazed by the call. His introduction for Dr Drew confirmed this:

"We have an expert right now that is going to bring on in just a second and I'm going to ask him some questions about that call because it still amazes me...


"...I'm talking about Dr Drew Pinsky..."


This, it seemed, was a golden opportunity for Pinsky to 'big up' Glaxo's product Wellbutrin.

Essel asked Dr Drew if it was possible to have as many orgasms as the caller had claimed.

Dr Drew told Essel that kind of thing typically happened from medication. On being asked by Essel, "What type of medication would increase someone's orgasmic potential where they go from three or four to 60?", Dr Drew replied:

"Interestingly lots of antidepressants, but the one that I have most...I've seen that from in my clinical practice is Butrin or **Buproprion. It's actually the one we advocate, one of the things we suggest people do if they're getting decrease in their libido or decrease in their arousal from an antidepressant which frequently occurs in the serotonin reuptake inhibitor medication. We think about adding Wellbutrin..."


**Buproprion is marked as Wellbutrin and Zyban by GlaxoSmithKline

To be fair, Dr Drew did mention two other medications.

Payments made to Dr Drew can be seen in Fig 1 & 2

FIG 1

FIG 2


This isn't the first time GlaxoSmithKline have used the voice of well known celebrities.

In 2004 American football hero Terry Bradshaw was, it appears, hired by GSK to promote another of their antidepressants, Paxil [known as Seroxat in the UK]

Bradshaw had gone public regarding his battle with depression and he 'took to the road' as a mental health advocate. His tour, which took in 12 US cities, was sponsored by GlaxoSmithKline.

Glaxo even offered Bradshaw his own web page, hosted on their own website. Sadly, the page does not appear when using the original url but with the modern wonders of the internet we can still access it here.

Here's a snapshot of how it appeared in 2006



As activism goes I have to take my hat off to former Paxil activist Rob Robinson. There's a chapter in my book dedicated to Rob so I won't go into too much detail about him in this particular post other than he once put the fear of God into Terry Bradshaw.

Bradshaw had planned to visit the Fortwood Center in Chattanooga, the hometown of Paxil activist Rob Robinson. Rob, who had previously organised a protest outside the offices of GSK, felt obliged to be present during Bradshaw's speech and had informed readers of his ground-breaking Paxil Protest website of his intentions.

Bradshaw caught wind and decided not to show thus leaving the Fortwood Center red faced and out of pocket as they had spent thousands of dollars promoting the event, including billboards around the city.

When Glaxo's CEO, Andrew Witty made a statement yesterday regarding his company and their appalling behaviour he blamed bygone era's. Thing is, how far back does Witty blame, does he include Glaxo's use of Terry Bradshaw to promote Seroxat [Paxil] during the tour of 12 US cities or was he just referring to the documents that are now publically available on the Department of Justice website?

It's safe to assume that I am not a fan of GlaxoSmithKline or Paxil. Their constant misdemeanors strike me as having a total disregard for human health [few links at foot of this post].

Can we really trust what Andrew Witty has to say? - "On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”

Where is the cut-off point that Witty is referring to here, is it 1999, 2004 or any other year that he wasn't in charge? By laying the blame on era's, he lays the blame on former Glaxo chief, Jean Pierre Garnier, that's quite a buck-pass, even by Glaxo's standards.

Witty became CEO of GlaxoSmithKline in in May 2008, any misdemeanors from that date onwards cannot surely be blamed on era's, can they?

Here's a few:

Glaxo Fined £60,000 For Killing 14 Babies - In 2012 GlaxoSmithKline were fined a measly £60,000 for its part in the 2007/08 vaccine trials conducted in Argentina where 14 children died. This was approx 1 year before Witty took charge of GlaxoSmithKline, can 2007 be deemed as a lesson learned and an era that Witty would rather forget about?


There are many more, some of which happened during Witty's reign as Glaxo chief.


The video below highlights just some of Witty's era at GlaxoSmithKline, much of which can be blamed on his predecessor, JP Garnier or at least the era while Garnier was in charge.


One has to remember Witty's remark following Glaxo's $3 billion payout - "Whilst these originate in a different era for the company, they cannot and will not be ignored."


I can just hear old JP Garnier... plus ça change, plus c'est la même chose.











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Monday, July 02, 2012

GSK - The Company With Great Ethics




Some of the headlines these past 24 hours or so regarding Glaxo's moral values:


Glaxo Agrees to Pay $3 Billion in Fraud Settlement
New York Times



GlaxoSmithKline settles healthcare fraud case for $3 billion
Reuters


GlaxoSmithKline Reaches Plea Agreement Over Drug Labeling
Businessweek


So, what's the hoo-ha all about?

Well, Glaxo, the company that likes to think it runs on great ethics, have just paid a record-breaking $3 billion for their part in illegally...yes, illegally, promoting their products to patient populations that their products could potentially harm, kill. Products such as their antidepressants, Paxil and Wellbutrin.

Paxil is known as Seroxat in the UK and Aropax in Australia and New Zealand.

Wellbutrin, on the other hand, is also used as an anti-smoking drug. Glaxo basically rebadged it to Zyban.

Part of this huge settlement is also because GlaxoSmithKline failed to report important safety data regarding their diabetes drug Avandia. We're not talking about damaged boxes here, we're talking about Avandia causing heart problems in those who took it.

How ethical, huh?

So, how did Glaxo promote Paxil and Wellbutrin illegally then?

Well, they'd get their reps to do the dirty work. Reps would visit doctor's and give them kickbacks, a kickback that would range from lunch being bought for the doc and his staff to lavish gifts and expensive restaurants. Not content with food bribes, the reps would then offer money to high prescribing doctors and psychiatrists to 'give a talk' to other doctors that would see them promoting the use of Paxil and Wellbutrin "off-label" to children.

You see, Glaxo didn't have to tell millions of TV viewers that their medications were safe and indicated for certain populations with their advertisements - they simply got doctors and child psychiatrists to do it for them. Why? Well, to advertise these facts would have been deemed as fraud. So with a little bit of jiggery-pokery they advertised by proxy to those that really mattered - the prescribers.

What astounds me, as a former consumer of Paxil, is the statement made by Glaxo chief Andrew Witty:

“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he said in the statement. “On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.” [source]

So, Glaxo have learned from their mistakes hey Andrew?

Last year Andrew Witty turned down the chance to speak with Janice Simmons. Janice runs the Seroxat User Group and she wished to talk to Witty about the withdrawal problems people were facing when trying to taper from Glaxo's drug.

This end, I have requested a similar type of meeting with GlaxoSmithKline New Zealand. They told me to "Talk to my doctor"

"On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”

Ho hum Sir Andrew.

How many deaths resulted in Glaxo's illegal promotion of Paxil and Wellbutrin? How many deaths resulted in Glaxo's failure to warn of the safety issues with Avandia?

One small piddling apology that, in essence, blamed another era of GSK, is simply not good enough. It's an insult to those who have lost their lives, an insult to those that have been left to carry the loss around on their shoulders.

Andrew Witty was knighted at the head of this year. Her Majesty rewarded him - for what exactly?

What kind of a message was this sending out? Hey, Glaxo have been bad but Andy is getting things back on track.

Yup, sure he is.

You know, money doesn't make the problem disappear overnight. The $3 billion had been earmarked at the start of the year. This is the sort of blasé attitude we have come to expect from GlaxoSmithKline, it's akin to a shrug of the shoulders and a smug smile, it's akin to a mass murderer or serial killer apologising just before he is administered a lethal injection.

GlaxoSmithKline have been caught time and time again with their trousers down. Out of court settlements are all well and good but they just pave the way for this industry to continue on their path of destruction. It allows them to wipe the blood from their hands, using the bank notes of any settlement to clean their conscience.

It's abhorrent... more than that...it's pure evil at work.

GlaxoSmithKline's Andrew Witty may want to think about changing the company tagline, "GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer."


Evidence of this huge settlement would suggest that the tagline is wrong. It would also suggest that GlaxoSmithKline are in disarray and if it were a single entity then it would have been diagnosed, using DSM criteria, as being narcissistic, delusional and, dare I say it, psychopathic.

The UK Seroxat litigation, where consumers of Seroxat, had difficulty withdrawing from Glaxo's product, still continues. Glaxo deny any wrong doing.


Three things cannot be long hidden: the sun, the moon, and the truth.
Buddha


Documents and Resources from the July 2, 2012 GlaxoSmithKline (GSK) Press Conference




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