Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Poland. Show all posts
Showing posts with label Poland. Show all posts

Tuesday, September 08, 2015

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.







Thursday, July 24, 2014

GSK: This Time It's Syria!





Welcome to the world of GlaxoSmithKline, a world where allegations of bribery and corruption are commonplace.

Reuters have just broke the news that British pharmaceutical giant GlaxoSmithKline are under investigation for bribery in Syria.

Add this to the following:

USA
UK
CHINA
IRAQ
POLAND
BAHRAIN
JORDAN
KUWAIT
LEBANON
OMAN
QATAR
UNITED ARAB EMIRATES


Reuters, in an exclusive, claim to have received an email from a person familiar with GSK's Syrian operations alleging bribes in the form of cash, speakers’ fees, trips and free samples.

"The detailed 5,000-word document, addressed to Chief Executive Andrew Witty and Judy Lewent, chair of GSK's audit committee, said incentives were paid to doctors, dentists, pharmacists and government officials to win tenders and to obtain improper business advantages.
"GSK has been engaging in multiple corrupt and illegal practices in Syria and its internal controls for its Syrian operation are virtually non-existent," the email said."

Reuters are also reporting that the email claimed that GSK "had engaged in apparent Syrian export control violations, including an alleged smuggling scheme to ship the drug component pseudoephedrine to Iran from Syria via Iraq."

Included in the email was information on alleged violation including payments of $1,500 each to two doctors to promote Panadol. Also alleged was that GSK bribes paid to pharmacists and payments for medics to visit a Mediterranean holiday resort.

These latest revelations come on the top of news earlier that GSK's shares fell by about 6%, a familiar downtrend for GSK, as the stock is now down 8% since July 10.

One word.

Karma.

Bob Fiddaman

Hat Tip - The Truthman




Thursday, June 05, 2014

Glaxo to Settle With More States in $105 Million Deal




Following yesterdays news, that Glaxo had entered into an agreement with the Oregon Department of Justice, comes news of further settlement agreements being reached in the US.

It's now being reported that GSK will pay $105 million to settle claims with California, New York and more than 40 other states that it illegally promoted asthma and antidepressant drugs.

The deal isn't just a monetary one...Glaxo, however, would like the general public to think that it is.

Part of the deal is that Glaxo have to stop using paid doctors to promote its products. Glaxo, after being fined a record breaking $3 billion in 2012 for similar offences, have claimed to be doing this off their own bat...when in fact their hand has been forced by these settlement agreements.

The State of California are to receive $7.1 million, the highest payment to any of the other states mentioned in the agreement. Texas stands to get $6.2 million under the deal, while Pennsylvania and New Jersey stand to receive $4.1 million and $2.45 million

Glaxo have also recently settled many Paxil birth defect cases, a figure that is estimated at $1 billion.

Glaxo have also recently been in the news for bribing doctors in China, Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria and Jordan - back story.

On May 27th the British Serious Fraud Office (SFO) announced that GlaxoSmithKline were being investigated by officials in Britain. I have wrote to the SFO asking them to elaborate on the investigation and also asked them if they will be investigating any bribery or fraud committed in the UK by GlaxoSmithKline. The SFO have wrote back but have, as yet, not announced if they will be investigating bribery or fraud from any of GSK's UK practices.

So, Glaxo settling claims against them left, right and centre at the moment.

They refuse, however, to settle claims brought against them by members of the British public regarding Seroxat [Paxil] and its propensity to cause withdrawal problems. A lawsuit, filed over 10 years ago, sees Glaxo refuse to compensate a number of British consumers who became addicted to Seroxat. Glaxo have refused to enter into any type of settlement agreement and have denied all allegations that Seroxat is addictive. This, despite settling with over 3,000 consumers who made claims against them in the US a number of years ago.

It seems that GlaxoSmithKline, a British company, can pay the consequences of their illegal activities in foreign countries but refuse to do so when they do the same on their own soil.

Don't you just love the British Justice system!

Bob Fiddaman.




Monday, June 02, 2014

Open Question to GlaxoSmithKline




Have your 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 have you, as a company, ever bribed UK government officials?

Just thought I'd throw this question out seeing as you are currently under investigation by the UK authorities.

I do hope the UK authorities move quickly and subpoena your hard drives, drives that you probably started deleting the second you caught wind that the UK Serious Fraud Office would be investigating you.

Oh, and just so you know, I've wrote to the investigators and offered my services - I've told them what to request from you - told them to focus around your promotion of Seroxat and the possible incentives you paid British doctors to prescribe it to kids. That's fraud, right? That's bribery, right?

Oh, I also told them to steer clear of the MHRA, let's face it, they are just an extension of GSK anyway.

Anyway, I may be wrong, hence the question....

Have your 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 have you, as a company, ever bribed UK government officials?

You know my email address, right?

Then again, you could just leave a message on my blog, seems like you were on here again earlier.



Bob Fiddaman




Tuesday, May 27, 2014

Are GSK Collecting Flags of Nations?




Fined a record-breaking $3 billion in the US for serious violations regarding the promotion of prescription medication to vulnerable patients [including children] - Excuse - "It was all part of an era"

Currently under investigation...

GSK investigated over fraud allegations in China - When the story broke GSK's Andrew Witty had this to say... "there are control mechanisms in place to prevent bribery and other forms of corruption, but that the methods these individuals used “would have been difficult to find using our controls.”

Almost one year later...

GSK's Mark Reilly Accused of Running a "massive bribery network" - Chinese officials investigating claims of bribery and corruption at GlaxoSmithKline's Chinese HQ have accused former head of China operations, Mark Reilly, of "personally running a "massive bribery network"."

Just before this announcement...

GSK - Latest Corruption Scandal In Iraq - 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.

Then came...

GSK accused of illegal marketing in Poland - This is what GSK had to say, “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."

Before the dust could settle...

Jordan and Lebanon - The Next GSK Scandal - GSK has launched an internal investigation into its operations in the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and Iraq.

"Sales representatives allegedly bribed doctors in Jordan to prescribe Glaxo drugs by issuing free samples that the doctors were then allowed to sell on, according to the emails.

"Glaxo representatives also allegedly permitted Jordanian doctors to bring their spouses on business trips that Glaxo paid for, according to the emails. Doctors were issued with business-class tickets to attend conferences but would exchange them at travel agencies for two economy-class tickets, allowing their spouses or other family members to come along free, a practice local Glaxo employees were aware of, according to the emails."


And now...

GSK faces serious fraud investigation in Britain - Britain's Serious Fraud Office (SFO) has launched a formal criminal investigation into GlaxoSmithKline Plc, posing a new challenge to the drugmaker, which already faces allegations of bribery in China and elsewhere.

Britain's biggest pharmaceuticals company said it had been informed on Tuesday that the SFO had "opened a formal criminal investigation into the group's commercial practices".

GSK said it would cooperate fully but gave no further details in a brief statement. A company spokesman declined to elaborate.

So, let's see.
















GSK have issued a press release regarding the latest fraud allegations in the UK.

The company said it would "co-operate fully" with the SFO.

Um... I don't think you have much say in the matter!

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

It's about time they changed the company tagline, doncha think?


Bob Fiddaman






















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