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

UK Serious Fraud Office and the GSK 3

By Bob Fiddaman and The Truthman

(Because two heads are better than one)

In 2014 it was announced that the Serious Fraud Office (SFO) were going to be investigating GlaxoSmithKline with regard to their nefarious activities that have recently come to light in countries such as China, UK, USA, Iraq, Poland, Bahrain, Jordan, Kuwait, Syria, Lebanon, Oman, Qatar and the United Arab Emirates.

As with all investigations we rarely get to see what is going on, that's why I found the following court document surprising, so surprising that I decided to invite long time friend and fellow blogger, the Truthman, on board to help me to some digging. Truthman's excellent exposé on GSK can be found on his blog, the aptly titled, "GSK, Licence To Kill."

The court document gives us three names, there may be more employees of GSK, past and present, that may have already been interviewed by the SFO or, as we suspect, many more who may be interviewed in the future.

The three GSK employees, two of them current and one a former employee, are, it appears, not cooperating with the SFO, each claiming that they have a right to be legally represented during those interviews.

According to court documents the three individuals were told by the investigating SFO that they could not have legal representation - the SFO later did a u-turn but told the three that they could not use the services of the same law firm representing GSK with respect to the investigation.

All three asked for a judicial review on the decision claiming that they had a right to use whoever they chose to represent them. The  High Court, after reviewing the original decision, found that the grounds were unarguable.


The three employees.

Whilst it's important to note that the three individuals are not suspects into GSK's alleged bribery and corruption, it's interesting to see the positions they hold at GSK. It's also interesting that these individuals, if they have nothing to hide, would hold up the process of the SFO investigation on the basis that they wanted their legal representation to come from the same law firm, Arnold & Porter UK LLP. If, the 'GSK Three' wished to help the SFO then surely it wouldn't matter who they were represented by.

So, who are the three?

1. Jason Lord. (No photo available)

Research shows that Lord was, in 2006, GlaxoSmithKline (GSK) Security Adviser in the Corporate Security and Investigations Department.

In 2006, Lord attended and gave a presentation at the Jordan Intellectual Property Association (JIPA), a membership-based association that has organized several IP training events in Jordan. (Web Archive)

For those that don't know, Jordan is another country currently under investigation. The claims are that GSK staff in Jordan have bribed doctors. The allegations relating to Jordan and also Lebanon were first reported in the Wall Street Journal, which cited emails from a person who first contacted GSK in December. The paper said the emails allege that GSK sales representatives bribed doctors to prescribe drugs and vaccines by issuing free samples to doctors that they were allowed to sell on.

Not much else is known about Jason Lord.


2. Paul Reynolds.

Paul Reynolds, GlaxoSmithKline

According to his LinkedIn page, Reynolds currently holds the position of GSK Head of Respiratory Marketing, UK.

Between July 2010 – March 2012 Reynolds was GSK's Senior Marketing Director, Seretide (Europe, Asia Pacific, and Emerging Markets)

Seretide  is a product manufactured and marketed by GlaxoSmithKline, it is used to treat Asthma.

In 2014, BBC Panorama aired 'Who's Paying Your Doctor?' where it was alleged that GSK paid doctors to promote GSK's asthma drug Seretide in Poland between 2010 and 2012.

Ironically, in 2012, Reynolds became Commercial Director, Retail for GlaxoSmithKline, a position which he held in Warsaw, Poland.

In 2011, Reynolds, wrote an article for the pmlive, a webiste about the pharmaceutical industry.

Some of his quotes, we feel, were misplaced. Maybe Reynolds was speaking from the heart when he said...

"Companies like GSK began taking action against the mistakes of the past many years ago. I feel that I operate in a company that  works tirelessly to do the right thing, not just to work within the  rules and to restore trust, but to act and operate transparently and  ethically, because it is the right and the only thing that a business  and an industry should do. Pushing at the boundaries against competitors or with customers, whether they are prescribers, payers or patients, is not good business. The industry was still learning to operate within a new space, having previously enjoyed much greater freedom. So, naturally the focus was on understanding how to operate within new rules, without contravening them.When I look back at this early part of my marketing career, I see the naivety of some of my actions and of those of people around me, as we tested how far we could go while staying within the remit of the Code. For me now, rules are to be bettered and not tested and this outlook is one I see as the norm today."

We find it interesting that Paul Reynolds mentions the 'pushing of the boundaries' early in his career. Was Reynolds suggesting the boundaries of what is ethical perhaps or what is legal? He also says that the industry previously enjoyed 'greater freedom', what exactly does he mean here? 'Greater freedom to do what? Considering  this article was written in 2011 and GSK were yet to be fined for their $3 Billion US fraud felony in 2012, and their China bribe operation in 2014, perhaps Paul Reynolds was being a little premature in his assessment of GSK's ethical compliance system?

As we mentioned, Reynolds currently holds the position of GSK Head of Respiratory Marketing, UK. Seretide is the UK brand name for Advair, as it is known in the US.

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]

3. Justin Mayger

Justin Mayger, GlaxoSmithKline

Mayger currently holds the position of Director, Compliance and Control Integration at GSK. He was first employed by GSK in 2005 where he took on the position of Senior Business Risk Consultant. Five years later saw Mayger take up the position of Director, Anti-Bribery and Corruption Prevention  (ABAC) at GSK. (LinkedIn)

The role of the ABAC is to investigate allegations as soon as it becomes aware of them. Part of GSK's policy on bribery and corruption in the business reads...

GSK has zero tolerance towards bribery and corruption. GSK employees shall not make, offer to make, or authorise payment to a third party (e.g. sales agent, distributor or intermediary) with knowledge that all or part of the payment will be offered or given to any individual to secure an improper advantage, obtain or retain business.

All three will now be interviewed by the UK Serious Fraud Office. It's unknown why the SFO have picked these three individuals to help with their investigation. 

The court document, THE QUEEN ON THE APPLICATION OF (1) JASON LORD (2)PAUL REYNOLDS (3) JUSTIN MAYGER Claimants v  DIRECTOR OF THE SERIOUS FRAUD OFFICE, can be downloaded here.

Glaxo's current CEO, 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?

GSK's CEO, Andrew Witty, said in a statement about the record $3 billion 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,” 

We think the SFO need to look further afield if they wish to get to the bottom of the whole Seretide promotional activities of GSK, if indeed that is their intention here.

Collectively, myself and co-writer, Truthman, strongly urge the SFO to interview Andrew Witty if they wish to know more about the respiratory drug promotion from GlaxoSmithKline. Let's face it, the guy must have a wealth of experience in all matters relating to the respiratory side of the business at the global pharmaceutical giant. Failing that, maybe the SFO should contact Peter Humphrey, he was hired by GSK China to investigate bribery claims, despite GSK denying that the claims were true - they later went on to plead guilty to the claims.

We would be extremely surprised if Andrew Witty ends up anywhere near a prosecution, given that lawyers representing GSK seem to be doing their very best to stall the investigation.

GSK have huge power and sway in the UK, they are a major cash cow, and one only has to look at  the board to see that there are many Knights of the realm (Sir's) who  make most of the executive decisions at GSK. In fact, GSK have so many Knights stewarding the company we could be forgiven if we mistook it as some kind of pseudo-Camelot, except these Knights certainly aren't as chivalrous.



Another Revolving Door

Trying to get a successful prosecution against GSK, or any individuals operating within GSK, may prove to be difficult given that Kathleen Harris, a former SFO lawyer, was recently hired as a partner at US-headquartered firm Arnold & Porter, the very same law firm who are defending Glaxo and who wished to represent the Glaxo three during their interviews. (Source) During her time at the SFO she supervised and provided strategic oversight to a number of high-level investigations and prosecutions. She also played a key role in developing seminal guidelines on critical issues, including plea negotiations, civil remedies, civil recovery and corporate prosecutions.

Upon leaving the SFO to join Arnold & Porter, Harris said, “Arnold & Porter has a prominent group of white collar defense lawyers with extensive criminal law experience on the prosecutorial side from the U.S. Justice Department and other regulatory agencies, as well as on the defense side. It’s great to be a part of this team.” (Source)

It wouldn't surprise us if the current SFO investigation comes down to some sort of plea negotiation between both parties. Both the Truthman and I hope we are wrong. History, however, may repeat itself as this is not the first time we have seen a revolving door between prosecution and defence where GSK have been involved in litigation or investigation. (see US Attorney General Eric Holder and the Revolving Door)

Contrast the SFO investigation with the MHRA's investigation into GSK and you will see such a huge difference. The SFO wish to seek the truth by actually investigating claims, where the MHRA carried out a near five-year investigation into GlaxoSmithKline, commencing in 2003 and ending in 2008, and, well, really didn't do much to find the whole truth.

GSK had failed to report in a timely manner adverse event data from clinical trials in children of its antidepressant, Seroxat (Paxil). (See Restoring Study 329) After nearly five long years the MHRA decided not to prosecute, not only that, it emerged that the MHRA did not even bother to interview any employees from GSK.

At the time, I, Bob Fiddaman, asked the MHRA, under the terms of the Freedom of Information Act, the following question...

“Why were MHRA enforcement investigators unable to question GSK staff?”

The MHRA replied...

Under UK criminal law suspects in criminal investigations can not be compelled to answer questions, they have a right to remain silent. Lengthy negotiations were conducted with solicitors acting for individual members of GSK staff and for GSK itself with a view to persuading them to attend interviews under caution. The conclusion of the correspondence was that all the potential interviewees indicated that they would not attend an interview under caution.

The individual suspects (as opposed to the corporate entity GSK) could have been arrested and required to attend an interview under caution. However they could still not be compelled to answer questions and, given that their solicitors had clearly indicated that they would not answer questions, the investigation team concluded that there was nothing to gain by carrying out arrests.

The near five-year investigation resulted in the MHRA sending GSK a "You've been naughty, but it's okay" type of letter, a letter that, the then current GSK CEO, JP Garnier, responded to by stating, that 'Glaxo had done nothing wrong.'

Talk about arrogance!

Maybe the MHRA should take a lesson from the Serious Fraud Office or, maybe the MHRA need to get better counsel?

Those in-the-know know why the MHRA did not prosecute GSK and it had nothing to do with their official explanation.

Let's hope that Messrs Lord, Reynolds and Mayger can provide the SFO with information they need to find the ringleader involved in the fraud and bribery, let's hope they (SFO) can show the British drug regulator how investigations should be carried out. Let's hope the SFO's investigation leads to criminal prosecutions and, hopefully, some custodial sentences.

With a former SFO employee now working for Arnold & Porter, our hopes may be dashed.

I hope I can make it across the border. I hope to see my friend and shake his hand. I hope the pacific is as blue as it has been in my dreams. I hope. - Red, Shawshank Redemption

Bob Fiddaman & The Truthman.

Glaxo Corruption Probe in Romania

Just when you thought it was safe to put your faith in medicine again comes another bombshell for British pharmaceutical giant, GlaxoSmithKline.

Still shaking off the putrid stench of the $3 billion fine in America and the $483 million fine in China, Glaxo now find themselves at the centre of yet more corruption, this time in Romania.

The news agency Reuters are reporting that they have had access to emails sent in to top GSK management that claim ...

• GSK paid Romanian doctors hundreds, and in one cases thousands, of euros between 2009 and 2012 for prescribing its medicines, including prostate treatments Avodart and Duodart and Parkinson's disease drug Requip.
• GSK paid for speaking engagements, but in three out of six cases, including the most highly paid one, they did not give any speech. The other three medics gave only one speech each, despite receiving multiple payments.
• GSK also provided doctors with many international trips and made payments to them under the guise of participation in advisory boards.

It's not looking good for Glaxo after the person who emailed the company has said that he/she will pass on evidence to both  the U.S. Department of Justice and the Securities and Exchange Commission (SEC), which are investigating GSK for possible breaches of the Foreign Corrupt Practices Act.

Full story here.

More coming soon.

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 - Three Strikes...and You're Still In.

What's the connection between China, Iraq and Poland?

Here's some subtle clues.


Clue Number One

Clue Number Two

Clue Number Three


Here's another clue in the form of a photograph.

Yesterday I witnessed a footballer for Swansea City being sent off by the referee for committing two fouls. He will now face a ban.

In the space of a few months British pharmaceutical company GSK have been embroiled in illegal activities in China, Iraq and Poland - They have not been punished for allowing these illegal activities to happen.

BBC's Panorama - Who's Paying Your Doctor?, airs tonight in the UK. The investigation will show how eleven doctors and a GSK regional manager have been charged over alleged corruption between 2010 and 2012.

A former sales rep said doctors were paid to promote GSK's asthma drug Seretide.

All part of an era huh?

GSK have issued a statement ahead of tonight's programme. You will note the lack of accountability.

“A GSK programme to assist in improving diagnostic standards and medical training, in order to benefit patient treatment and care with regard to respiratory disease, was run by doctors and other healthcare professionals in Poland. The programme ran from 2010 to 2012.

“Training on proper diagnostics for medical personnel and group meetings for patients were organised as part of this programme. These sessions were delivered by specialist healthcare professionals who, based on contracts signed with GSK, received payments appropriate to the scope of work as well as their level of knowledge and experience. The provision of sessions under this programme was agreed with the Polish healthcare centres.

“Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company. The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result.

“We continue to investigate these matters and are co-operating fully with the CBA.

“We agree there is a need to modernise interactions between the pharmaceutical industry and healthcare professionals to ensure patients’ interests are always put first and to eliminate even a perception of a conflict of interest. This is why we have made, and will continue to make, fundamental changes to our business such as opening up access to our clinical trial data, changing how we pay our sales representatives and stopping payments to healthcare professionals for speaking engagements and for attendance at medical conferences.”

Good old Glaxo - making an official statement AFTER they have been busted.

Bob Fiddaman

GSK - Latest Corruption Scandal In Iraq

Fined over $3 billion for violating federal law in the US, part of a corruption investigation in China - What more for British pharmaceutical giant GlaxoSmithKline?

Well, a whistleblower has come forward alleging that GlaxoSmithKline employees in Iraq are up to no good.

According to the Wall Street Journal [WSJ] "A person familiar with Glaxo's Mideast operations emailed the U.K. drug company late last year and earlier this year to report what the person said were corrupt practices in Iraq, including continuing issues and alleged misconduct dating from last year and 2012."

WSJ adds, "The emails cite behavior similar to Glaxo's alleged misconduct in China, including alleged bribery of physicians."

The allegations cited include but are not limited to:

• Hiring 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government.

• A government-employed Iraqi emergency-room physician prescribing Glaxo products, even when they weren't in the hospital's pharmacy and a competitor's brand was in stock.

• Paying expenses to government-employed doctors to attend international conferences.

The WSJ also writes... "In 2012 Glaxo Iraq won the contract to supply the company's Rotarix vaccine, Glaxo paid for a workshop in Lebanon for Iraqi Ministry of Health officials, the email said. That included paying for a doctor's family to travel to Lebanon "so it would be a family vacation for him at the hotel."

In 2011 Glaxo Iraq signed an agreement with Modern Drug Industries, an Iraqi company, to manufacture and package drugs in Baghdad. At the time GSK said producing drugs closer to the customer would improve their cost base and enable them to sell products on at an "access price".

Hmmmm.

GSK's company tagline is "We are a leading healthcare company that helps people to do more, feel better and live longer"

Bob Fiddaman



Hat tip - The Truthman

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?

Glaxo Shortlisted for Britain’s Most Admired Company

Definition of ADMIRATION [merriam-webster.com]

1 archaic : wonder
2 an object of esteem
3 delighted or astonished approbation

Despite Glaxo's recent plea of guilty to fraud and subsequent $3 billion fine in the US, Britain sees Glaxo as a totally different corporation.

Glaxo have been shortlisted for one of Britain's Most Admired Companies awards by Management Today, in association with the Business Standards Institution [BSI]

The awards, write Management Today, are a peer review of corporate reputation. Canvassing the opinions of 200 of the UK’s largest companies, they are the only awards of their type in the UK.

Glaxo are no strangers to receiving awards from Management Today. After being shortlisted for Britain's Most Admired Companies in the year 2000, they actually went on to win it!

Management Today claims that it aims to help managers and business leaders "succeed today, and keep succeeding tomorrow". BSI, who are also associated with the awards, claim that "for more than a century, we've been challenging mediocrity and complacency to help our clients across the world embed excellence into the way they work…so they perform better, reduce risk and achieve sustainable growth.

On hearing the news of Glaxo's nomination I wrote to the editor of the Management Today website.

Dear Sir/Madam,

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.

GlaxoSmithKline - You're An Embarrassment

In the words of Suggs, lead vocalist with Brit Ska/Pop band, Madness, "You're An Embarrassment."

Our uncle he don't wanna know he says

"We are a disgrace to the human race", he says

"How can you show your face

When you're a disgrace to the human race?"

No commitment, you're an embarrassment

Yes, an embarrassment, a living endorsement

The intention that you have booked

Was an intention that was overlooked

Now watch the video.

In Defence of Glaxo: Stephen Whitehead Speaks Out

ABPI CEO, Stephen Whitehead

Friend and fellow advocate RC over at Seroxat Secrets alerted my attention to a recent post in the New Statesman where the wheels of PR have kicked in and underplayed Glaxo's history of abhorrent behaviour.

The Association of the British Pharmaceutical Industry's CEO, Stephen Whitehead, felt the need to contact the New Statesman after a review by Helen Lewis of Ben Goldacre's new book, Bad Pharma: How drug companies mislead doctors and harm patients. 

I've not read Goldacre's book yet, ordering from Amazon when one lives in New Zealand is like waiting for a bus that never arrives. I will, however, obtain a copy at some point.

What's striking about Whitehead's letter to the New Statesman is his defence of British company GlaxoSmithKline, let's not forget that Glaxo are not American or a Japanese corporation, they are British so any actions, be they good or bad, blemish the the Union Jack flag.

Whitehead, just like Glaxo CEO, Andrew Witty, blames nobody but a bygone era, further adding that pharmaceutical companies being fined "...are all examples from the US and simply not relevant to the UK market."

Oh gee, and there was me thinking that Glaxo's cancerous corruption was worldwide, what was I ever thinking? Thanks for putting me straight on that one Mr Whitehead.

Marty "Bling Bling" Keller Retires from Brown Uni

Lead author of the now infamous Paxil 329 paper, Martin Keller, has, it seems, retired from his position at Brown University. This will no doubt free up some time for the hard working child shrink so he can sit on more pharmaceutical advisory boards [for a fee] or attend more symposiums [for a fee] or maybe give after-dinner speeches [for a fee].

Keller, along with the study he is supposed to have wrote, became infamous around the time GlaxoSmithKline were trying to push their antidepressant, Paxil, on children and adolescents.

Paxil, known as Seroxat in Europe and Aropax in Australia and NZ, was never meant for children and adolescents but Glaxo pushed it on this population regardless.

The study, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression", has caused much controversy over the years. In a nutshell, it's a piece of fraud and lists Martin Keller as the lead author. The study itself was penned by Sally Laden, a ghostwriter hired by GlaxoSmithKline. Laden miraculously turned three poor Paxil clinical trials into one good one. In truth, children and adolescents would have had a better chance of survival in a clinical trial for Russian roulette.

Calls for Keller to be removed from Brown Uni have been loud. Brown Uni have stood by their man as much as the Journal where the ghostwritten study appeared all those years ago.

I'm not the first to slam this study, many have done it before me, Leemon McHenry, John Juriedini, Evie Pringle, Shelley Jofre, Alison Bass, to name but a few. For what its worth, I even added my two penneth for the study to be retracted.

Many continue to dissect it, One Boring Old Man author being one such advocate.

What I do know is that this study has been responsible for persuading doctor's around the world to prescribe Paxil to children and adolescents 'off-label'. This sits perfectly well with Keller et al and the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]. It would appear that having a misleading piece of literature which, in essence promotes an unsafe drug to children and adolescents doesn't really bother GlaxoSmithKline either, if it did surely they would have asked for its retraction. Why would they though, it would be an admittance of fraud.

Sara Carlin and Sharise Gatchell are just two examples of what can happen to children on Paxil. They both hanged themselves. The 329 study showed there was an increase in suicide for Sara and Sharise's age group, an increase that was hidden by GlaxoSmithKline.

For those unfamiliar with the whole fraud behind Glaxo's study it's easily explained in the half hour documentary aired by BBC TV's Panorama team, the fourth investigation into Paxil. [Video below]

GlaxoSmithKline have been let off the hook on numerous occasions. Their role in the 329 study should never be forgotten. Keller and all those other key opinion leaders who added their names to the study should, along with ghostwriter Sally Laden, be utterly ashamed that the influence of their names has caused so much heartache for families bereaved by suicide.

Those who added their names to the study are listed below. Not one of them, to my knowledge, has apologised for their part in influencing doctor's in prescribing Paxil to children and adolescents. They can argue that they didn't know but they have each had more than enough time to retract their names from the study or, at the very least, speak out about how it... or they was manipulated by GSK.

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. Winter

Rosemary Oakes

James P. McCafferty

News of Keller's retirement can be seen on the blogs of Alison Bass and Ed Silverman

BBC Panorama documentary about the fraudulent study is below.

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Paxil - Multiple Symptoms, One Solution

So, we all know how Glaxo failed to show the efficacy and safety of Paxil use in kids, we all know how they buried data and hired a ghostwriter to dupe doctor's, journal editor's and parents of kids. Basically, a suicide link was seen in the clinical trials, Glaxo covered it up. We all know how Glaxo reps were given carte blanche by executives at Glaxo to pay doctor's large sums of money, carefully disguised as preceptorship's and/or fees for attending and sitting on advisory boards. All this on top of the lavish weekend breaks for doctor's and, in some instances, their partners.

That's business, eh folks?

The following is a letter from the FDA's Division of Drug Marketing, Advertising and Communications [DDMAC] to GlaxoSmithKline warning them about their promotional activities regarding Paxil and children.

Remember, Glaxo had not got a licence for Paxil in children, none the less they saw fit to push it on them in the despicable way.

Basically, Glaxo distributed a T-shirt during a Health Fair function at the Children's Advocacy Center of Brevard in Brevard, Florida. The front of the T-shirt saw the logo and name of the Children's Advocacy Center, while the back of the T-shirt saw the claim "Multiple Symptoms, One Solution" followed by the Paxil logo.

Here's the letter, courtesy of the Drug Industry Document Archive, from the FDA to Eloise R. Scott, D.V.M. Associate Director, U.S. Regulatory Affairs at Glaxo, formerly Smithktine Beecham Pharmaceuticals.

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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







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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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