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Researching drug company and regulatory malfeasance for over 16 years
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Showing posts with label Seretide. Show all posts
Showing posts with label Seretide. 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.







Friday, May 16, 2014

GSK Hiked Product Prices to Fund Bribery Scam





So, this is how it worked folks.

GlaxoSmithKline China, under the management of Mark Reilly, allegedly told sales reps to bribe doctors, hospitals and health institutions. As a result GSK's sales soared from 3.9 billion Yuan in 2009 to 6.9 billion Yuan in 2012.

The video below shows a GSK sales manager...


"If the doctors prescribed more of our drugs they would be rewarded accordingly.
"We would treat them to dinners or buy gifts for their families, sometimes it was even more direct, we just gave supermarket gift cards or cash during holidays."

Obviously GSK would need to balance the books with so much bribery money going out of the door. So, how did they do this?

Well, Chinese authorities have learned that GSK simply inflated drug prices by declaring high cost at Chinese customs.

Authorities found that GSK's drugs were being sold to China at prices that far exceeded the prices they charges other countries, sometimes as much as 8 times. [Fig 1]

I'm guessing that this wasn't just down to Reilly, he must have had help from elsewhere, from senior management in the UK perhaps?



Fig 1


GSK's Mark Reilly, whom I wrote about previously on this blog, faces up to 10 years in prison.


Here's the CCTV News report.





Bob Fiddaman.



Back story

I'm Just a Blogger - Here's GSK Served on Prawn Crackers





Wednesday, May 14, 2014

I'm Just a Blogger - Here's GSK Served on Prawn Crackers



GSK's Mark Reilly faces up to 10 years in prison


Thought I'd give my take on GSK and the recent [ahem] bribery scandals in various parts of the world. I say 'my take' because it's something that GSK or their highly paid attorney's can't 'take' from me. It's mine and I wish to share it.

So, news today that Chinese officials have charged the former British boss of GSK's China operations.

And what have they accused him of?

Well, nothing out of the ordinary [by GSK's standards that is]

Mark Reilly fled China when the going got tough. He later returned, not as a goodwill gesture - he returned because the Chinese police wished to interview him, a result of which saw him arrested then, some months later, charged with offences relating to bribery.

GlaxoSmithKline CEO, Andrew Witty, has kept quiet since his initial statement he made midway through last year. He claimed that neither he or GSK HQ in the UK knew anything about the corrupt practices occurring in their China branch.

So news today that has implicated a British employee who has been charged with corporate bribery, bribing non-government officials and bribing business units should force some kind of statement from Witty. Alas, he remains tight-lipped.

Are we expected to believe that Mark Reilly, upon his initial return to the UK in July 2013, lied to Andrew Witty?

10 days into the investigation and GSK's head of operations in China, who at this point fled the country, is replaced by someone else. Who smelled the rat, or was this just standard procedure when an employee from GSK is under investigation?

Reilly has enjoyed an illustrious career at GSK. He joined them in 1989, 5 years later, in 1994, he became Finance Director, Discovery Research, WWR&D before moving on to become Assistant Corporate Controller, Corporate Finance, a position that lasted 2 years.

In 1999 he became Vice President Finance UK Pharmaceuticals, this lasted for just over 4 years before he decided to try his hand abroad.

From 2003 to 2006 Reilly was based in Singapore, his title, Vice President Finance, Asia Pacific.

He returned to the UK to take up the position of Senior Vice President, International Finance - this lasted just 2 years before Reilly was, once again, jet-setting.

Between January 2009 – January 2010 he was General Manager, China Pharmaceuticals. In February 2010 he added Hong Kong to his title - thus becoming General Manager, China Pharmaceuticals and HK.

So, where exactly did it go wrong for Reilly?

Was he just a bad egg in a company who have always played things by the book?

Was he the runt of the litter?

Was he just a rogue employee who went off the rails because of a personal greed?

Or is this simply a culture at GSK?

It was early in his career at GSK, 1994, that Reilly was introduced into the world of finance. From that point Reilly seems to have made a very rapid climb up the promotional ladder at GSK.

Reilly has a BSc, Medical Sciences, he has a PhD, Pharmacology/Neurosciences - strangely, between 1987 – 1989 he added an ACA in Business, Finance and Accounting to his list of honours. The ACA qualification is one of the most advanced learning and professional development programmes available.

Safe to assume then that Reilly was no mug.

We can see from a 2010 presentation given by Reilly that a goal of GSK was to gain more sales of its respiratory drugs in China.

In fact page 12 of his presentation pretty much spells it out for us all. [Fig 1]

"Respiratory market is a major opportunity"



Fig 1

Let's look at when news of the Chinese scandal first broke.

According to interviews published by Xinhua, the official state-run news agency, several GSK employees have confessed to bribing doctors with gifts, travel, lecture fees and cash bonuses to persuade them to prescribe more of the company's drugs.
A man surnamed Li, who is a regional sales manager at GSK China in central China's Henan Province, said that salespersons at the company received special training on sales skills and methods, especially how to maintain relations with hospitals and doctors, Xinhua reports.
The man, who is in charge of selling respiratory drugs to more than 10 hospitals in the province's capital city Zhengzhou, added that salespersons established good personal relations with doctors by catering to their pleasures or offering them money, in order to make them prescribe more drugs. [Source]

 "Respiratory market is a major opportunity"

A doctor from a “reputable hospital” whose real name was not given, claimed that one GSK representative had “blatantly offered kickbacks to doctors”.
“For example, 20 yuan [£2.11] for each pack of Seretide, an asthma-treating inhaler; and 10 yuan [£1.05] for each dose of Flixotide, an asthma-treating spray.”
If a doctor appeared reluctant to accept cash, GSK “salespeople” would offer them “gifts, free travel after meetings and lecture fees.”
“In fact, many doctors received lecture fees even when the lectures did not exist,” Xinhua reported. [Source]

Seretide is a drug manufactured and marketed by GSK, a drug used in the treatment of...you've guessed it, respiratory problems. It's also the same drug that Reilly referred to in his 2010 presentation [Fig 1]

"Less than 1m current patients on Seretide"

What better way to increase the number of patients on Seretide than to offer cash incentives to doctor's who prescribe it!

Putting the Chinese scandal aside for just one moment. Let's just focus on a BBC Panorama programme that aired a few weeks ago in the UK.

Panorama's 'Who's paying your doctor?' saw investigative journalist Shelley Jofre unearth new evidence that Glaxo were pretty much doing the same thing in Poland.

Jarek Wisniewiski, who worked as a sales rep for GSK Poland for eight years told Panorama that in 2010, he worked on a marketing programme across Poland to promote Seretide. He said that, on paper, money was provided for educating patients about the drug but claims it was, in reality, paying doctors to prescribe more of the medicine. He added...


“I pay for education and in the same meeting I said that I need more prescriptions for Seretide. So … they knew exactly for what I pay.” [Source]


So, how did we get from one illegal promotional push of Seretide in China to another illegal promotional push of Seretide in Poland. The two countries are miles apart.

Was an executive decision made that "We should do as the Chinese do" or was it merely a coincidence that GSK Poland was operating in pretty much the same way as GSK China?

One drug pushed illegally in two different countries and Glaxo's CEO knew nothing about it?

Back in July 2013 a Glaxo spokesperson claimed that...

"We take all allegations of bribery and corruption seriously. We continuously monitor our businesses to ensure they meet our strict compliance procedures. We have done this in China and found no evidence of bribery or corruption of doctors or government officials." [Source]

Exactly who is it at GSK that monitor its businesses to ensure they meet their strict compliance procedures?

Why hasn't this person/persons been hauled over the coals for failing to join the dots with regard to the bribery that was, seemingly rife, in China?

Thing is, and this has been evident throughout the years with GlaxoSmithKline, they are a company - any wrong-doing by an employee is covered up and it's left to outside investigators to try and find the culprit, the man/woman who 'pushed the button', so to speak.

It's only when the outside investigation pinpoints the ring leaders that we have Glaxo come out and say how shocked they are and that they will do everything in their power to help the investigation.

This is when GSK become transparent, they do so not of their own freewill, they do so because their hand has been forced by the strong arm of the law. However, they do it in such a way that dupes the general public into believing that they have always been as transparent as ever.

Think about it. If GSK were transparent they wouldn't have had so many lawsuits filed against them. Lawsuits are only filed because GSK initially deny charges brought against them. In law, GSK don't want to have to admit to anything because it sets a precedence - this is why we see them time and time again settle cases brought against them out of court - when a case is settled they get those who brought the claims against them to sign confidentiality agreements - in essence these agreements state that GSK accept no liability of the charges made against them.

China is a different kettle of fish though. Legal experts are suggesting that GSK's Mark Reilly could face up to 10 years in prison. Let's hope it's not Beijing's Municipal Prison.

Troy Bremer, an Australian found guilty of fraud, spent a number of years at Beijing's Municipal Prison. "The officers destroy your body, mind, heart and spirit", he told the Sydney Herald in an exclusive interview back in 2013.

Heaven forbid that Reilly gets sentenced to 10 years in a hell hole such as Beijing's Municipal Prison. Whatever he's done it does not warrant such abuse.

Hopefully Reilly will see sense and try to cut a deal. The most obvious 'Get out of jail card' he could play would be to name names, to tell the authorities he did what he did because he was told to by senior executives.

I mean, why protect the scum that has left him out to dry?

Bob Fiddaman







Monday, April 14, 2014

UPDATED: GSK's UK Seretide Promotion





Tonight BBC Panorama exposes yet more allegations of bribery from British pharmaceutical company GlaxoSmithKline. The program, which airs on BBC One at 8.30pm, will reveal new evidence that GSK was recently paying doctors to boost prescriptions of their asthma drug Seretide in Poland.

Hmmm...

Why go as far as Poland?

The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry at arm’s length of the ABPI.

Trawling through the number of case reports on their website we can see that GlaxoSmithKline were, in 2012, being investigated due to allegations made by one of its employees regarding the promotion of, and/or staff training on, Revolade (eltrombopag), Seretide (fluticasone/salmeterol) and ReQuip XL (ropinirole).

This wasn't in Poland folks... it was in the UK.

This from the alleged breaches...

The complainant alleged that the hospital business manager’s team falsified a Seretide product certification examination. All of the managers sat the product knowledge test at the same time and the answers were read out by a team member as instructed by a manager. This deliberate action, following limited training, meant that the hospital business managers were not adequately trained on Seretide when they engaged with customers. The complainant subsequently provided additional material in support of this allegation.

The complainant alleged that it was not a bona fide training event and the answers were read out to participants. GlaxoSmithKline explained that it was a knowledge consolidation event rather than evaluation, at the end of an online product training course. The Panel noted that, according to the unsigned witness statements provided by GlaxoSmithKline, whilst at least one participant completed the test alone, the majority appeared to have completed the informal test collaboratively, with the benefit of discussion.

The Panel noted GlaxoSmithKline’s submission that when HHBMs had discussions with payer customers to support specific brands, they underwent product training. The Panel noted GlaxoSmithKline’s submission that in 2011 HHBMs received 20 days of training of which 13 were product training which GlaxoSmithKline considered provided them with knowledge above and beyond that required by their role. The Panel noted that the HHBM training for Seretide in 2011 comprised product training on two separate days (neither were full days). In addition, the HHBM team did distance learning for Seretide and brand managers delivered updates at HHBM team meetings. The Panel noted GlaxoSmithKline’s submission about the need for further training to enable HHBMs to have more detailed discussions. The Panel noted that GlaxoSmithKline had, in effect, acknowledged the need for further training on Seretide. The Panel noted that the complainant bore the burden of proof. The Panel had some concerns about the HHBM Seretide training but did not consider that the complainant had demonstrated on the balance of probabilities that the product training was inadequate given the nature of calls likely to be made; no breach of the Code was ruled.

PDF Here.

Be interesting to see if this employee, who made the allegations, is still around. Hey, if we can find the mysterious American woman, (see 1, and 2) then a UK employee of Glaxo should be a breeze.

Were you that employee?

Do you know who that employee was?

Drop me a line.

Updated: Here's the Panorama programme that aired last night.





Bob Fiddaman.












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