How to Polish a Turd, the GSK Way

A recent interview with Glaxo's Andrew Witty saw BBC journalist, Evan Davis, more or less told how to phrase questions. Davis had broached the subject of Glaxo's murky past - Witty, using the art of deflection, told Davis, "I think the bigger question is, where do you want to go forward?"

So, how do you polish a turd?

Well, you talk about what you have in the pipeline, (excuse the pun) thus eliminating tricky questions about the following...



6/4/2015 - India Meningitis Vaccine Market Collusion - GlaxoSmithKline, Sanofi-Aventis - $9,442,587

9/15/2014 - Clean Air Act Violation at Hamilton, MT Facility - GlaxoSmithKline - $172,900

8/11/2014 - Hazardous Waste Violations in King of Prussia - GlaxoSmithKline - $317,550

6/4/2014 - Multistate Illegal Marketing Settlement - GlaxoSmithKline - $105,000,000

5/13/2014 - China Bribery and Fraud - GlaxoSmithKline - $487,000,000

3/25/2014 - Mylan v. GlaxoSmithKline (Breach of Generic Paxil Agreements) - GlaxoSmithKline - $106,700,000

3/18/2014 - Contaminated Drug Ingredients at Ireland Plant - GlaxoSmithKline - FDA Warning Letter

12/17/2013 - Maryland Diabetes Drug Improper Marketing Lawsuit - GlaxoSmithKline - $15,000,000

7/24/2013 - Multistate Avandia Settlement (July 2013) - GlaxoSmithKline  - $184,000,000

6/14/2013 - Cappellino v. GlaxoSmithKline (Gender Discrimination) - GlaxoSmithKline - Complaint

4/19/2013 - OFT Paroxetine Antitrust Investigation - GlaxoSmithKline - U.K. Office of Fair Trading Press Release

2/5/2013 - Louisiana Off-Label Marketing Lawsuit - GlaxoSmithKline - $45,000,000

11/15/2012 - Multistate Avandia Settlement (November 2012) - GlaxoSmithKline - $90,000,000

11/15/2012 - Flonase Antitrust Litigation - GlaxoSmithKline - $150,000,000

7/9/2012 - Dolin v. GlaxoSmithKline (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

4/17/2012 - Idaho Average Wholesale Price Lawsuit - GlaxoSmithKline - $2,600,000

2/7/2012 - Defrauding Louisiana’s Medicaid Program - GlaxoSmithKline - $10,000,000

1/11/2012 - Argentina Vaccine Trials Fine - GlaxoSmithKline - $93,000

11/3/2011 - Criminal and Civil Investigations Settlement - GlaxoSmithKline - $3,000,000,000

10/27/2011 - South Korea Antitrust Fine - GlaxoSmithKline - $2,651,737

10/7/2011 - Current Good Manufacturing Practice Violations at Worthing, UK Facility - GlaxoSmithKline - FDA Warning Letter

6/27/2011 - Nigeria Trademark Infringement - GlaxoSmithKline - $7,873,706

6/23/2011 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $40,750,000

5/17/2011 - South Carolina Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

2/15/2011 - Louisiana Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

11/17/2010 - Humana v. GlaxoSmithKline (Reimbursement for Avandia-Related Injuries) - GlaxoSmithKline - Complaint

11/9/2010 - Utah Attorney General Avandia Lawsuit - GlaxoSmithKline - $8,500,000

10/26/2010 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $750,000,000

10/6/2010 - Hawaii Average Wholesale Price Litigation - GlaxoSmithKline - $10,000,000

8/30/2010 - Kentucky Kytril and Zofran Average Wholesale Price Lawsuit - GlaxoSmithKline - $3,750,000

7/12/2010 - U.S. Senate Investigation of Avandia - GlaxoSmithKline - Senate Finance Committee Letter to FDA

6/23/2010 - Paxil Birth Defect Litigation - GlaxoSmithKline - Confidential settlement with 190 families 

4/19/2010 - FDA Review of Altabax Promotional Material - GlaxoSmithKline - FDA Warning Letter

10/13/2009 - Kilker v. SmithKline Beecham (Paxil Birth Defects) - GlaxoSmithKline - $2,500,000

10/1/2009 - Denture Cream Product Liability Litigation - GlaxoSmithKline - Complaint

12/23/2008 - Santa Clara County Drug Pricing Lawsuit - GlaxoSmithKline, Wyeth - Complaint

9/30/2008 - Paxil Class Action (National) - GlaxoSmithKline - $40,000,000

7/26/2008 - Medicines Australia Code of Conduct Violations - GlaxoSmithKline - $310,000

7/21/2008 - Relenza Litigation Settlement - GlaxoSmithKline - $19,500,000

5/19/2008 - Release of TCE in Scottsdale, AZ - GlaxoSmithKline - EPA Press Release

5/2/2008 - Wellbutrin Direct Purchaser Antitrust Litigation - GlaxoSmithKline - $49,500,000

2/27/2008 - Bartram v. GlaxoSmithKline (Paxil Birth Defects) - GlaxoSmithKline - Complaint

12/17/2007 - Avandia Marketing, Sales Practices and Products Liability Litigation - GlaxoSmithKline - $770,000,000

10/6/2006 - Paxil Class Action Litigation (Madison County, IL) GlaxoSmithKline - $63,833,148

9/11/2006 - Under-reporting Profits - GlaxoSmithKline - $3,400,000,000

7/10/2006 - Cunningham v. GSK (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

3/28/2006 - Paxil Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $14,000,000

9/20/2005 - Zofran and Kytril False Claims Act Violations - GlaxoSmithKline - $150,000,000

4/1/2005 - Relafen Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $10,000,000

11/24/2004 - Relafen Consumer Litigation - GlaxoSmithKline - $75,000,000

8/26/2004 - Paxil New York Litigation - GlaxoSmithKline - $2,500,000

7/8/2004 - Augmentin Antitrust Litigation - GlaxoSmithKline - $92,000,000

2/6/2004 - Relafen Antitrust Litigation - GlaxoSmithKline - $175,000,000

4/16/2003 - Overcharging Medicaid - GlaxoSmithKline - $87,600,000

9/6/2002 - Average Wholesale Price (AWP) Drug Litigation - GlaxoSmithKline - $70,000,000

6/6/2001 - Tobin v. SmithKline Beecham (Paxil Wrongful Death) - GlaxoSmithKline - $6,400,000


**TOTAL - $10,057,614,485 (That's 10 billion, folks!)


**Federal Contractor Misconduct Database


There are many more missing from the Federal Contractor Misconduct Database, most notably the settlement (resolution) GSK made with over 3,000 Paxil plaintiffs who alleged the drug had caused them addiction problems, Also missing is the individual payment made to Pennsylvania mother Joanne Thomas who settled with GSK after losing her original case against them, see here and here.
The UK Seroxat Group Action is also missing from the list. The claim alleges that UK consumers become dependent upon the antidepressant, Seroxat. (Paxil)

Then, of course, we have the on-gong investigations of bribery and corruption in the following countries, United Kingdom, Iraq, Poland, Bahrain, Jordan, Kuwait, Lebanon, Syria, Oman, Qatar, and United Arab Emirates.

The mission of GSK, according to their website, is to improve the quality of human life by enabling people to do more, feel better and live longer.

(Insert laughter here)



Bob Fiddaman

GSK: Racketeer Influenced and Corrupt Organizations Act

So, what exactly is the Racketeer Influenced and Corrupt Organizations Act [RICO]?

Basically it's a federal law designed to combat organized crime in the United States, it was introduced in 1970 and has been used to prosecute members of the Mafia.

On June 30, 2014, Attorneys representing GlaxoSmithKline, asked the Court of Appeals to throw out racketeering claims in three class actions that had accused them of hiding heart disease risks associated with the diabetes drug Avandia.

In 2013 Pennsylvania U.S. District Judge Cynthia M. Rufe refused to dismiss claims made by three union benefit funds under the Racketeer Influenced and Corrupt Organizations Act, ruling the plaintiffs had adequately alleged a scheme whereby GSK suppressed evidence of Avandia’s cardiovascular risks to increase the number of prescriptions written and covered.

The crux of GSK's appeal is that District Judge Cynthia M. Rufe erred in her initial ruling. They claim, “A plaintiff cannot be injured by a misrepresentation about a health care product unless the plaintiff personally receives a ‘compromised or diminished’ benefit from the product as a result.”

More on GSK allegedly violating the Racketeer Influenced and Corrupt Organizations Act here [Subscription only]

Back in 2011 GSK also failed in their efforts to have Plaintiffs' Proposed Specific Causation Expert Witnesses Nicholas DePace, M.D excluded from giving testimony. Their motion was denied, once again by Pennsylvania U.S. District Judge Cynthia M. Rufe   [More here]

Bob Fiddaman

What GSK Told Reps to do.

The following video is for the UK Serious Fraud Office (SFO) who announced last month that they will be investigating GlaxoSmithKline.

It's assumed that the SFO will only be investigating Glaxo's foreign bribery allegations and won't be delving into any alleged bribery or fraud committed in the UK.

If the SFO think that Glaxo's UK practices are whiter than white then they really should take some time out to watch this video.

Blair Hamrick was one of the whistleblowers that blew the lid on Glaxo's off-label promotion of drugs and also how they bribed US doctor's to prescribe Glaxo's drugs.

All the SFO have to do is what I did. They need to put Glaxo UK in the spotlight and ask them if their sales team, including senior management and reps, paid doctors, hospital officials and health institutions to use GSK products in the UK, resulting in the "illegal revenue" of hundreds of millions of British pounds. Or if they, as a company, ever bribed UK government officials?

If GSK answer 'No' then the SFO can do one of two things.

1. Believe them

2. Investigate to see if they are telling the truth.


Here's the video.




Related stories.

A Message From the UK Serious Fraud Office re GSK

Cronyism, Chinese Style

GlaxoSmithKline: The Andrew Witty "Era"

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


Bob Fiddaman

GSK - A Runaway Train...Running Right Off The Track

If there is one corporate company still operating when it really shouldn't be that company that stands head and shoulders above any other I know is British based GlaxoSmithKline.

No sooner had they been found guilty for a whole host of violations in the US [Resulting in an estimated $3 billion fine] they are back in the news again for yet more violations, this time in China.

The Chinese violations are currently under investigation. GSK head honcho, Andrew Witty, has denied knowing about the shenanigans going on in China which include:

• Bribing doctors with cash payments
• Bribing doctors with sexual favours
• Using a network of more than 700 middlemen and travel agencies
• Inventing meetings that required travel payments (these payments were given to doctors to persuade them to prescribe GSK products)

Glaxo's $3 billion fine in the US is just another piece of the jigsaw. Before this they have made settlements in and out of US Courts, paying defendants compensation and slamming down gagging orders as part of the settlements... in other words nobody can go public with amounts paid to them.

Let's just take a look at some of the other violations committed by GlaxoSmithKline over the past few years.

Cidra

Glaxo's Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company's sale of Paxil (Seroxat) and Paxil CR.

A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo's Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004

Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra... they didn't.

After leading her recovery team Eckard found more violations that the FDA had missed first time round.

In a nutshell, she brought this to the attention of her senior managers, her managers ignored her... then fired her.

According to Eckard's complaint: "persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. ... rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for "black market" packaging and distribution ..."

Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it's committed to continuously improving manufacturing quality. The company denied Ms. Eckard's allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.

Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.

No criminal charges were laid against Glaxo despite allegations of their involvement in selling on rejected batches of drugs to MOVA Pharmaceuticals.

Avandia 

Glaxo suppressed patient-level meta-analysis of safety data from Avandia trials which demonstrated an estimate of excess risk of ischemic cardiovascular events and other potentially life-threatening complications.

A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication. 

During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.

In 2012, after being ordered to pay $90 million to resolve allegations by prosecutors in 38 states that the they illegally marketed Avandia, Glaxo had this to say:

 "The company did not admit to any wrongdoing or liability of any kind under these states' consumer protection laws in this settlement" 

Paxil (Seroxat) Birth Defects

After deliberating for seven hours, a state court jury in Philadelphia found that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.

The case was the first to go to trial of more than 600 suits claiming that Glaxo hid knowledge of birth defect risks allegedly tied to Paxil. 

What did Glaxo have to say after being found guilty?

“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.” 

You'll probably find that the jury thought otherwise Glaxo.

Paxil (Seroxat) Suicide

On December 14, 2009, Bloomberg published an article entitled “Glaxo Said to Have Paid $1 Billion in Paxil Suits.” 

The article reported:

GlaxoSmithKline PLC has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.

Why did they do this?

Well, it's down to the Schell case in 2001.

Donald Schell, 60, had been taking Paxil for just two days when he shot and killed his wife, his daughter, his granddaughter and then himself.

Remaining members of the family filed suit.

During the trial GSK [then SmithKline Beecham] internal documents showed the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging didn't, at the time, include a warning about suicide, violence or aggression.

Glaxo were found guilty and ordered to pay $6.4 to the remaining family members.

What did Glaxo attorneys say after this particular defeat?

"Paxil is a very effective medication in helping depression," attorney Charles Preuss said after the trial. "Our only regret is that Mr. Schell did not have Paxil for a longer period of time." [Link]

The link between Paxil and suicide has been raging for years.

Here's what former Head of Psychiatry at GlaxoSmithKline, Alistair Benbow, had to say in a BBC interview.

Benbow {A} was being interviewed by investigative journalist Shelley Jofre.{Q}

Q. Let us move on. What has the company done about the Wyoming (Schell) verdict?

A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed...

Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.

A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.

Again, I think the jury would disagree with Benbow here.

If Glaxo believed their product was innocent in the suicides of these people why would they settle further cases? One such case involving the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.

They then settled with the family later.

Paxil (Seroxat) Addiction

In its 2008 annual report, Glaxo officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.

In other words a gagging order was place. This enables Glaxo to defend any further lawsuits regarding Paxil addiction. One such lawsuit is the UK Seroxat litigation which Glaxo are defending.

The UK lawsuit has been dragging on for over 10 years now. Glaxo have refused to make any such compensatory settlements to any UK citizen.

So, just a few reasons why it comes as no surprise to learn that Glaxo have been behaving badly in China. No surprise that Witty is denying any knowledge of what went on in China either.

Even when found guilty Glaxo continue to deny any wrong-doing... that trend will continue until compensation is put to one side and criminal charges are laid against the top executives at Glaxo. They are the past masters of buck-passing, of laying blame on others, of waving wads of cash [dangling carrots] in front of victims in the hope that a settlement can be reached. With settlement comes suppression and Glaxo just love suppression.

I anticipate that the bad behaviour in China will be settled and those responsible [the top management] will deny knowledge and let the area managers take the fall.

That's their style, always will be until someone has the balls to come down hard on the senior management at GlaxoSmithKline.

Someone really needs to put a stop to this runaway train.

Bob Fiddaman

To Hell and 'Back' With GlaxoSmithKline

It never rains but it pours for poor old GlaxoSmithKline, or should that be GlaxoSmithSpine? Fresh on the back [ahem, excuse the pun] of a $3 billion fine from the US Department of Justice they have now been told by the Australian Federal Parliament to set up a charity and look after a possible 60,000...yes, that's 60,000, victims harmed by it's product, Myodil.

There's an estimated 60,000 Aussies who have been left crippled with pain, paralysed and incontinent because they were injected with a dye during an x-ray procedure. The dye was, at the time, the only way doctor's could see the spine clearly.

Glaxo Finish in 26th Position... But Spin Victory

Back in November I wrote how GlaxoSmithKline had been shortlisted for Britain's most admired company. When I learned that they had been shortlisted I wrote a brief email to the editor of the Management Today, who were offering the award. In a nutshell, I aired my disgust at their nomination, citing Glaxo's various violations over the years.

Management Today never replied.

No surprise then that Glaxo were blowing their own trumpet on their Facebook page early in December after they had learned that they had won the most admired company in the Health & Household category. [Fig 1]

Fig 1

The Health & Household award was a sub-category and the reason why Glaxo felt the need to cover themselves in garlands on their Facebook page was probably due to the fact that they finished in 26th position overall. Now there's some spin for you, huh?

GSK, Avandia and Jack the Ripper

I always love it when GSK attempt to cover themselves in garlands, particularly after being fined $3 billion for, amongst other things, marketing deathly drugs to children.

The Washington Post recently ran an article entitled, "As drug industry’s influence over research grows, so does the potential for bias." The article was heavily critical of Glaxo's bias when it came to reporting all the facts in clinical trials.

The Washington Post article centred around a 2006 report that compared three diabetes drugs, one of which was Glaxo's Avandia. The reported concluded:

"We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies" - Lawson Macartney, Senior Vice President of GlaxoSmithKline

What Macartney failed to add was the trial, according to the Washington Post,  "had been funded by GlaxoSmithKline, and each of the 11 authors had received money from the company. Four were employees and held company stock. The other seven were academic experts who had received grants or consultant fees from the firm."

The article, to date, has prompted 645 reader comments, the majority of which are highly critical of GlaxoSmithKline.

So, in a massive PR [Yawn] exercise, Glaxo have responded with the usual roll-out of  "we don't do this anymore". 

Jack the Ripper [presumed dead] was a notorious unidentified serial killer during the late 1800's. His murdering spree, which some believe to be 5 women, involved the mutilation of his victims.

Can you imagine if, during the late 1800's, Jack admitted these killings and issued a press release stating that he was a good man now and didn't kill any more? Furthermore, can you imagine if Jack had been caught by the investigative police force at the time and fined rather than imprisoned for his crimes?

Jack the Ripper was a deplorable man [could have been a woman, although I doubt it] who carried out heinous acts against vulnerable women. Could we, as a nation of sane mind been forgiving if Jack had publicly announced that he had turned over a new leaf?

There are many critics of GlaxoSmithKline, I remember one blogger many years ago using the abbreviation GSK to form Global Serial Killers - He [could have been a she, although I doubt it] was pretty much on the money.

Let's take a look at Glaxo's response to the Washington Post article.

Let's also take a look at how Jack would have made a similar statement.

GSK: "...accept that we operate differently today"

GSK's Deirdre Connolly

Deirdre Connolly, President - North America Pharmaceuticals, GlaxoSmithKline, delivered a speech to the Pharmaceutical Regulatory and Compliance Congress on November 5, the crux of which was a plea for people to start trusting GlaxoSmithKline again.

Again?

Connolly, speaking at the 13th annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, opened the gates to criticism when she told the audience, “We need those we serve, and those who make sure we conduct our business appropriately, to accept that we've changed … Continue to hold us accountable, but accept that we operate differently today.” 

Continue to hold us accountable?

Okay. Thanks for that D. I, for one, shall try my hardest.

Once again, and just like Glaxo CEO, we see the blaming of an era at GSK, implying that the current compliance protocol is robust and that they, GSK, are transparent. To be transparent one would have to give reasons why - Glaxo, on two occasions now, have covered themselves in garlands for opening their doors to show how transparent they are. What they don't tell us is that they were more than likely forced to open their doors as part of agreements and settlements with DA's and Department of Justice.

If, as Connolly suggests, “Trust is a two-way street,” then maybe she could start by retracting the study at the centre of many cases against her company.

Email to Editor of JAACAP - Re Paxil 329

Below is an email I've sent to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]

It follows on from the recent abhorrent behaviour of British pharmaceutical company, GlaxoSmithKline and their agreement to plead guilty with regard to the way they knowingly misbranded Paxil and knowingly falsified a ghostwritten study [329] for the sole purpose of making money from a product that had a propensity to induce suicide in children and adolescents.

A call for this fraudulent study to be retracted has previously been asked for by Jon N. Jureidini and Leemon B. McHenry, whom are both mentioned and referenced below.

I've previously called for Glaxo CEO, Andrew Witty, to contact JAACAP, seeing how it was his company that hired a ghostwriter for the article.

His limp-wristed excuse that this was part of an era just doesn't wash. If he had any morals then he would tell the journal to pull the study, although the damage has been done now and many children may have died as a result of this study being published.

More about Witty coming soon on this blog... there's some disgruntled whistleblowers out there.

Anyway, here's the email to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry.


Dear Mr Martin,

I am the author of the book, The evidence, however, is clear; the Seroxat scandal, and the blog, Seroxat Sufferers. Seroxat is the UK brand name for GlaxoSmithKline's antidepressant, you will know it by its US brand name, Paxil.

The reason I am contacting you is with regard to the publication in the Journal of the American Academy of Child and Adolescent Psychiatry entitled, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al.

It is my understanding that the particular study was used as a marketing tool by British pharmaceutical giants, GlaxoSmithKline, and was in fact not written by the authors, Martin Keller et al, at all but by Sally Laden, an editorial director for Scientific Therapeutics Information.

Given that this publication has been widely available since 2001 its safe to assume that many inquiring doctors, pediatrics, child psychiatrists and, in general, healthcare professionals, have used it as a guide when making a decision whether or not to prescribe Paxil off-label to children and adolescents.

It is also my understanding that the study, better known as Paxil 329, has been brought to your attention in the past by Jon N. Jureidini and Leemon B. McHenry and despite pointing out to you Paxil 329'S flaws you refused to retract it. In fact, you added that, “We have found no evidence for such errors nor any justification for retraction according to current editorial standards and scientific publication guidelines. We therefore will not proceed further with your request” [1]

I am sure you are aware of recent events regarding GlaxoSmithKline's guilty plea surrounding the illegal marketing and promotion of many of their products, one of which was Paxil.

Glaxo agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.  331(a), 333(a)(1) & 352(a). That 'misbranded drug' was Paxil.

Transcripts of GSK's plea and settlement agreements are available on the Department of Justice website. [2]

Regarding Paxil and their guilty plea, Glaxo settled allegations that:

From 1999 to 2003, during sales calls, dinner meetings, spa programs, lavish weekend conferences to places such as Puerto Rico and Hawaii, through a false and misleading medical journal article, and through the distribution of free samples for patient use, GSK promoted Paxil to doctors for the treatment of depression and, to a lesser extent, obsessive-compulsive disorder in patients under age 18.

and

That they conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, GSK failed to demonstrate efficacy on the endpoints identified in the study protocols.

and

That they hired a contractor to write an article on one of the studies that was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article stated that Paxil “is generally well tolerated and effective for major depression in adolescents.” The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol.

and

There marketing team distributed the JAACAP article to all of the Paxil sales representatives with a cover memo that stated that Paxil had demonstrated “REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Some GSK sales representatives used the article to urge doctors to prescribe Paxil to treat patients under age 18.

Given that they have pleaded guilty one would assume that the next natural step would be for the study to be retracted. I gather the responsibility falls upon you to issue such an order.

Can you tell me if you plan to retract "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al, and/or issue an explanation as to why you wish to retract it?

If you plan not to retract it could you please explain why?

Could you please also state, for the record, that your position is that you can still see no evidence of errors nor any justification for retraction according to current editorial standards and scientific publication guidelines.

Meantime, I look forward to your reply and hope that you will find it in your heart to remove this fraudulent publication as a goodwill gesture to the parents of children that have killed themselves as a result of Paxil induced suicide after it was prescribed to them by doctor's, pediatrics, child psychiatrists and, in general, healthcare professionals, whom used your journal as a reference when weighing up their decisions to prescribe it to this vulnerable population.

Yours sincerely,

Bob Fiddaman.

[1] Jureidini, Jon N. and McHenry, Leemon B.(2011) 'Conflicted Medical Journals and the Failure of Trust', Accountability in Research, 18: 1, 45 — 54
[2] Department of Justice - GLAXOSMITHKLINE SETTLEMENT FACT SHEET - http://www.justice.gov/usao/ma/news/GlaxoSmithKline/Settlement_Fact_Sheet.pdf







Fid

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Glaxo's Andrew Witty and Paxil 329

Two recent articles grabbed my attention of late, both are brilliantly written, both drag up the Paxil 329 study once more.

Jonathan Leo, Ph.D. - wrote, 'Study 329′s Authors: Should Those Who Live in Glass Houses Throw Stones?' Whilst Paul Basken penned, 'Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement'

Both are well worth the read.

Both got me thinking.

With Glaxo Chief, Andrew Witty, blaming everyone but himself for the abhorrent way his company, GSK, hid the Paxil suicide link in children I can only assume that the fraudulent marketing by his company would be something he wants to obliterate from his company.

There have been calls for the academics involved in the shameful Paxil 329 study to be criminally prosecuted. The study, headed by child psychiatrist, Martin Keller, was actually written by Glaxo. Keller, along with other key opinion leaders, added their names to the paper to make it look like they had each played a part in testing the safety of Paxil in kids. Truth is, they didn't.

Truth is Paxil wasn't safe for children to take.

Keller and the rest of the 'experts' have to live with that.

The study itself was, after being passed around for three years between child psychiatrists, lawyers and PR firms, published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry. Calls for it to be removed/retracted have been ignored by the journal.

Now, if Glaxo chief, Andrew Witty, had indeed been ashamed by his company's recent $3 billion payout for illegally promoted, among other drugs, Paxil, then surely it's down to him to contact the Journal of the American Academy of Child and Adolescent Psychiatry to ask them to retract the offending fraudulent study?

I'd like to give Witty a helping hand here. His company, Glaxo, haven't really done anything to help me or the  thousands of others wean off their addictive Paxil but, hey, you don't give to receive, right?

With this in mind I've devised a letter for Witty to simply sign and send off to the American Academy of Child and Adolescent Psychiatry.

All you have to do is sign it Witty. [Just print off and send to the journal, there's a good chap.]

For those, like me, who can't read small print, here's the letter in full:

Sir Andrew Witty

GlaxoSmithKline

980 GreatWest Road

Brentford

Middlesex

TW8 9GS

Dear, Journal of the American Academy of Child and Adolescent Psychiatry,

It is with great regret that I have to report that a study, A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase, sent to you under the guise of many highly thought of and influential psychiatrists, is actually false and misleading and could potentially cause harm to the patient population it was supposed to protect... children and adolescents.

The company I am now chief executive of, GlaxoSmithKline, have recently plead guilty and paid $3 billion as part of this criminal and civil resolution. 

We agreed to plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act.

Regarding Paxil, we agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, we also agreed to plead guilty to distribution of a misbranded drug due to inadequate directions for use, that drug was called Wellbutrin, you may know it as Zyban, that's down to me and my former role as VP Manager back in 1997... those were the days. Anyway, I digress, we also agreed to plead guilty to failure to report data to the FDA the adverse effects our diabetes drug, Avandia, was having on people. I heard a ripple that some folk died whilst taking this drug but I don't believe in anecdotal reports.

Anyway, back to the study.

We conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, we failed to demonstrate efficacy on the endpoints identified in the study protocols.

Because of this we hired a contractor to write an article on one of the studies [329] that was published in July 2001 in your journal.

The article stated that Paxil "is generally well tolerated and effective for major depression in adolescents." The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol. We kind of thought that if we would have mentioned that it had failed  demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints then we would not have been able to have a fair fight with Eli Lilly, who, at the time, were winning the antidepressant war with their particular poison, Prozac.

The study that our article referred to wasn't in fact written by any of the names that appear on it, namely, Martin B. Keller,  Neal D. Ryan, Michael Strober, Rachel G. Klein, Stan P. Kutcher, Boris Birmaher, Owen R. Hagino, Harold Koplewicz, Gabrielle A. Carlson, Gregory N. Clarke, Graham J. Emslie, David Feinberg, Barbara Geller, Vivek Kusumakar, George Papatheodorou, William H. Sack, Michael Sweeney, Karen Dineen Wagner, Elizabeth B. Weller, Nancy C. Winters, Rosemary Oakes, and James P. McCafferty.

I realize that by coming clean on this I am bringing into dispute the names of those above, who, for years, have all claimed that they played a part in the study. In fact the whole thing was drafted by Sally Laden, an editorial director for Scientific Therapeutics Information. You may have already seen the leaked memo from my company that sees the apparent lead author of the study, Martin Keller, write to Sally with, "Dear Sally, You did a superb job with this. ... It is excellent. Enclosed are rather minor changes from me."

As you may be aware, Martin Keller, or Marty as I like to call him, has gone on to earn vast amounts of money sitting on Advisory Boards for various pharmaceutical companies who want their antidepressants given that golden hallmark. Many others in the list have faced the wrath of a growing army of patient advocates/bloggers too. Poor old Stan Kutcher took a hammering a while back and subsequently failed to get elected in Novia Scotia, Canada. Karen Wagner seems to be doing well, although I understand she's under close scrutiny for a paper she wrote [ahem] about the safety of another antidepressant apparently being safe for kids, despite a previous study claiming that it wasn't. Neal Ryan made himself look rather silly when he was confronted by that Scottish bint, Shelley Jofre, from the BBC whilst the others have been pretty good at deflecting questions about their role in writing our study.

Many children have died by suicide whilst taking our drug, Paxil, many of whom should have been protected by us as we, as a caring company, had a duty to protect the most vulnerable. Alas, we failed and we failed on a huge scale.

Well, it's time to push that era away and to start making amends. So please could you retract the Paxil study from your journal and maybe offer an apology on my part for all the kids that have died since its publication. Although we can't say for sure that they carried out killing themselves because they were taking our drug, we still can't rule it out.

Sorry for any inconvenience this may cause you but I'm turning over a new leaf to get the public believing in GlaxoSmithKline again. I'm even going to blow the lid on my own past as VP Marketing Manager, that's if that pesky whistleblower, Greg Thorpe, doesn't beat me to it.

I hope to hear from you soon.

Please remember to to do more, feel better and live longer.

Yours sincerely,

Sir Andrew Witty

{SIGN HERE}

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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.

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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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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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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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