Netflix, Painkiller & the GSK Connection

 

Netflix hit on a gem when they launched Painkiller, the story of the Sackler family owned Purdue Pharma and the outrageous promotion of the painkiller, Oxycontin.

It's compelling viewing, even for those who have little understanding about pharmaceutical reps and their persuasive ways to get doctors to prescribe something that really isn't safe at all.

Each show starts with a member of the public making the disclaimer, “This program is based on real events. However, certain characters, incidents, locations, and dialogue have been fictionalized for dramatic purposes.” They then hold up a photo of a loved one lost to Oxycontin addiction.

Episode 5, Hot, Hot, Hot, hit home for me, particularly. It shows how Richard Sackler, played by Matthew Broderick, ignores the news that many hundreds of thousands had died of overdosing on OxyContin. Undeterred, he walks onto a stage, complete with sunglasses, to a mass of Purdue Pharma reps, in the main, good-looking females. They break into a frenzy as Sackler announces, "We are burning up the competition with sales of OxyContin, it is now the number one opioid brand in the country." Adding, "We are not stopping."

In reality, however, it wasn't Sackler who addressed the gushing Purdue Pharma reps, it was an executive named 'Mark'.

This from the website MotherJones:

"You know, it’s always hot here in Palm Springs. That’s why it’s a perfect place to have our meeting … because we’re hot … we’re burning up the competition with our sales of OxyContin! Do you know it’s now the number one prescribed opioid brand in the U.S.?"

“Now, you’re probably wondering what else can be done to sell even more OxyContin,” Mark went on. “There are also some things we’re cooking up for the coming year to help you and OxyContin and the whole pain market as well.” These initiatives allegedly included collaborating with the American Pain Society to develop materials that would “be distributed to hospitals across the country” and “weekly feature stories about pain and its management in newspapers.” The goal, said Mark, is to “raise awareness of undertreated pain” and to “Make the whole pie bigger, not only for us but for our competition as well.”

Mark concluded:

"I hope you enjoy your stay here in Palm Springs, I know I will. Enjoy the weather … because let me tell you, OxyContin’s continuing success, is going to make every part of this country from Seattle to Detroit to New Orleans as hot as it is here in Palm Springs this winter for every one of you. You are the force for the future … let’s make it happen!"

It could have been Mark Timney who, at the time, was a CEO for Purdue. This is just speculation on my part. 

GSK Advair

In 2012, British pharmaceutical giant, GlaxoSmithKline (GSK), agreed to pay $3 billion in a fraud settlement.

The three criminal charges involved Paxil, Wellbutrin and Avandia and included a criminal fine of $1 billion. The remaining $2 billion involved fines in connection with a civil settlement over the sales and marketing practices of the blockbuster asthma drug Advair and several other drugs.

Before Advair’s approval, a Glaxo scientist told the FDA that it wasn’t appropriate for patients with mild asthma. The agency agreed but it took five years to make that clear on the drug’s label. Advair, an asthma drug, generated more than $80 billion in global revenues. 

GSK has faced hundreds of lawsuits and claims brought by people whose relatives died while taking Advair.

So, why do I bring this up?

Well, the Department of Justice (DOJ) publicly released many exhibits from the 2012 fraud settlement, one of which was a video that shows an eerily similar scene as depicted in the Netflix mini-series, Painkiller.

If you've already watched Painkiller, you'll know what I'm talking about.

Watch the video from Advair’s Las Vegas product launch. Advair’s product manager, Jim Daly, asks the crowd, “Who wants to be a millionaire?” He adds, “There are people in this room who are going to make an ungodly sum of money selling Advair.”

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.

GSK: Thou Shalt Not

The recent settlement agreement between British pharmaceutical giant GlaxoSmithKline and a number of US states has been posted online - it makes interesting reading.

In a nutshell, 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.

It's only when we look at the terms of the settlement that we see how Glaxo have had their hand forced to be more transparent with what they do as a company, including their clinical trial results.

Last year GSK teamed up with AllTrials, an organisation that campaign for clinical trial transparency and support its call for the registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs).

The mainstream media and Alltrials, spearheaded by British doctor and author, Ben Goldacre ,rightly or wrongly, started singing the praises of GSK.

GSK, in fact, were also covering themselves in garlands, professing to be the first pharmaceutical company to release such information.

To outsiders it looked like a major turning point in the field of safe medicines but there are many that are not convinced of GSK's collaboration with AllTrials.

Glaxo announced their collaboration with AllTrials on the AllTrials webpage.

At GSK, we are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. We already publicly disclose a significant amount of information about our clinical trials. We register and post summary information about each trial we begin and share the results of all our clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. We have also previously committed to seek publication of the results of all of our clinical trials that evaluate our medicines to peer-reviewed scientific journals.

Expanding on this, we have committed to make CSRs publicly available through our clinical trials register. From now, we will publish CSRs for all of our medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.

In addition, while there are practical challenges, we also intend to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, we will put in place a dedicated team to conduct this work which we expect to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.

Separately, we are also working to develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of our clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge.

Back slaps all around then.

Their announcement came on the back of a $3-billion U.S. settlement in 2012 over misleading information about some of its drugs.

A few days ago Glaxo also settled with a further 44 US states. The settlement terms being pretty much the same as the terms they agreed to in 2012.

Let's take a look a some of those terms.

CLINICAL RESEARCH

The following subsection shall be effective for eight years from the Effective Date of this Judgement.

GSK shall report research in an accurate, objective and balanced manner as follows and as required by applicable law.

GSK shall register GSK-sponsored Applicable Clinical Trials beginning after the Effective date with the applicable registry and submit results of GSK-sponsored Applicable Clinical Trials completed after the Effective date to the registry and results data bank as required by the FDA Amendments Act of 2007.

For any GSK product, GSK shall also post on GSK's clinical trial registry any observational studies or Meta-analyses conducted by GSK that are designed to inform the effective, safe and/or appropriate use of any GSK product.

Remember, this 2014 agreement is pretty much in-line with the 2012 agreement GSK made with the US Department of Justice.

On GSK's promotional activities, the judgement/settlement states...

The following paragraphs D through F shall be effective for a period of eight years from the Effective Date of this Judgement.

D. GSK shall not make in a promotional context a representation, or suggestion, not approved or permitted for use in the labelling or under the FDCA that a GSK product is better, more effective, useful in a broader range of conditions or patients, safer, has fewer, or less incidence of, or less serious side effectsor contraindications than has been demonstrated by substantial evidence, or substantial clinical experience whether or not such representations are made by comparison with other drugs or treatments, and whether or not such a representation or suggestion is made directly or through use of published or unpublished literature, quotations, or other references.

E. GSK shall not promote any GSK product by use of Promotional Materials that...

1. Contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience.

...

...3. Present information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does or

4. Uses statistics on numbers of patients or counts of favourable results or side effects, derived from pooling data from various insignificant or dissimilar studies that suggest either that such statistics are valid if they are not or that they are derived from large significant studies supporting favourable conclusions when such is not the case.

F. When presenting information about a clinical study regarding GSK products in any Promotional Materials, GSK shall not do any of the following for information that may be material to an HCP prescribing decision:

1. Present favourable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions.

2. Use the concept of statistical significance to support a claim that has not been demonstrated to have clinical significance or validity, or fails to reveal the range of variations around the quoted average results.

3. Use statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data from studies the design or protocol of which are not amenable to formal statistical evaluations.


Now, let's take a look at some GSK spin.

Earlier this year GSK's Deidre Connolly wrote a piece on the Harvard Business Review blog entitled 'Bonuses Should Be Tied to Customer Value, Not Sales Targets'

She writes...

Critics may say it took a settlement with the U.S. Department of Justice over past sales and marketing practices to reach that conclusion. But we dropped sales targets well before the settlement, recognizing that traditional sales incentives were out of line with society’s expectations for our industry, and we had to change. Ultimately, past practices affected customer trust and satisfaction and, as a result, damaged the reputation of our industry.

What Deidre fails to mention is the settlement took nigh on 10 years, during which time GSK would have been making changes. Fact - the whistle had been blown on GSK's illegal promotional activities, they were being investigated. She claims that GSK dropped sales targets well before the settlement - of course they did - they were rumbled. She fails to mention that GSK dropped sales targets during the investigation.

Question is two-fold.

1. Why change something that was working so well for GSK if it wasn't illegal?

2. Why did it take GSK so long to make such changes?

Connolly's spin is typical of GSK being caught with their pants down. It serves one group of people, not us, the paying consumer, not doctors, that prescribe GSK drugs, but shareholders. Those that have a financial interest in GSK.

It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency. I hope that makes sense? First time I've used the word transparency twice in one sentence.

Further spin continues on Twitter in the shape of GSK's Mary Anne Rhyne.

Rhyne has often been the spokesperson for GSK, particularly where their product Paxil [Seroxat] is concerned.

Through the years Rhyne has had this to say...

These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/21/2002

Notice the substitution of the word 'withdrawal' for 'discontinuation'

Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.”
Mary Ann Rhyne
GlaxoSmithKline spokesperson
11/11/2002

So, in 2002, it appears that Rhyne was all for wining and dining doctors in an effort to get them to prescribe more drugs.

If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
2005

This was in answer to reports that Paxil was causing a lot of people severe withdrawal symptoms. "Limited to two weeks"? Who is she kidding!

We follow the law, and we follow government guidelines.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/26/2005

[Insert laughter here]

Rhyne is now on Twitter. Below we see her posting a link to Deidre Connolly's piece on the  Harvard Business Review blog. [My response to her, which she never answered, is also included in the snapshot]

So, from collaborations with AllTrials to settlement agreements with US states, GSK have now, seemingly, put their past behavior to bed.

I cannot understand why AllTrials campaigner, Dr Ben Goldacre, would wish to be associated with GSK. In fairness he does chastise GSK. On Twitter he posted the following, once again the question I threw out, along with fellow blogger, Truthman, was ignored.

It's a fair enough question, don't you think?

Why, indeed, would Alltrials wish to be associated with GlaxoSmithKline?

Were they duped into believing that GSK, off their own bat, joined forces because transparency is the name of the game?

Reading all of the above would suggest otherwise.

Sadly, Ben has resorted to name calling on Twitter. A few months ago I asked him to send me a private message via Twitter.

Ben was promoting an updated version of his book 'Bad Science'.

We did, eventually talk via email but nothing came of it.

First time in my life that I've been labelled an 'angry, smeary conspiracy theorist' though.

My only question to Ben still remains unanswered. Why would he want AllTrials associated with GlaxoSmithKline?

The full settlement agreement can be downloaded here.

Bob Fiddaman.

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.

GSK's Breo: "Don’t ignore the pneumonia risk!"

In the past GlaxoSmithKline have wined and dined ["dine and dash"] doctors as a means of getting their drugs ahead of competitors when it comes to filling out prescription pads. They are not the only pharmaceutical company to apply this tactic.

In the past GlaxoSmithKline have invited doctors to symposiums at lush holiday resorts, an all-expenses paid trip to do what you want to do providing you attend the symposium on this or that drug. Again, they are not the only pharmaceutical company to use this tactic.

On Oct 5, 2013, 100 of the top lung doctors in the U.S. gathered at a Hilton hotel in Houston. You see, Glaxo have a new baby they wish to hit the public with and one of the most effective ways to target the public is to target the agents who sell [prescribe] to the public.

Breo, Glaxo's new respiratory drug, is now on the advertising [by proxy] table but now the rules have changed. They can no longer tell doctors about the efficacy without first warning them of the dangers and much of the Hilton promotion was spent spelling out the dangers of Glaxo's new blockbuster drug.

Last year Glaxo were handed down a $3 billion fine for illegally marketing medicines, one of which was Advair, a respiratory drug. Glaxo were found guilty of pushing Advair for all asthma patients, even though it was only recommended for severe cases. Glaxo executives through their reps bribed doctors to prescribe Advair to patients that it wasn't meant for, in other words they told doctors that Advair was beneficial for minor asthma sufferers... when they knew that it wasn't. As a result FDA researcher David Graham estimated that long-acting beta agonists, of which Advair was one, contributed to an estimated 14,000 asthma deaths from 1994 through 2007.

“With the old way we did things, you emphasized the efficacy and benefits,” said James Donohue, a professor of medicine at the University of North Carolina who received a fee from Glaxo for chairing the Oct. 5 Houston meeting. “At the end, you’d always include the safety, but you just brushed over it. Now there’s a huge emphasis on the side effects.” [1]

So, what's with the new approach from GlaxoSmithKline, are we expected to believe that they have turned over a new leaf and are telling us everything about their drugs so we, the public, can make an informed decision as to whether we use their product?

It would be nice to think so wouldn't it. Alas, it appears that this new initiative only applies to Glaxo's new products and they are, more or less adhering to the US Justice Department. Glaxo are not doing this because it is right, they are doing it to avoid further fines.

If GlaxoSmithKline were that concerned about its products they would come out of that dark closet of denial and warn the public about the dangers of Seroxat [known as Paxil and Aropax].

Of course, they've already made their billions on Seroxat, it's since gone generic, which means other pharmaceutical companies can sell it.

Glaxo are claiming to be transparent and, in essence, they are. But this transparency was forced upon them. It's akin to giving a small child razor blades to play with, you know it's wrong but you continue to hand out the blades. You will do so until you are caught. Once caught you, because you are a pharmaceutical company that will always avoid jail time, will pay the fine and announce that you have changed your ways, "The razor blade thing was just part of an era".

In the UK there are a number of patients who took Seroxat and had severe withdrawal problems when trying to come off it. A lawsuit was filed but Glaxo have denied any wrong-doing, spouting the line "Seroxat has benefited millions of people world wide", at every given opportunity.

The UK group action is yet another classic example of how GlaxoSmithKline operate. Let's just say that those razor blades were Glaxo's Seroxat. Those people that were injured are ignored by Glaxo. They hire top lawyers to defend the claims against them... even though they have settled similar claims in the US [without liability]

If the UK litigation, which has been dragging on for 10 years, does get to the High Court then Glaxo will defend the test case, it's testing the water to see whether or not they will defend the other 100 or so cases.


So when I see articles about how Glaxo have changed their ways I think 'Nah, they are still exactly the same'.

Glaxo are a business and they want to make money, lots of it. Publicly they now have to be seen to be the good guys, hence the reason for highlighting the downside of their new product Breo.

However, what goes on behind closed doors is another matter. District managers at Glaxo have a unique way of selling products to people that don't need them, if they didn't tell their reps to target those who didn't need their products then, well, they'd be out of a job.

Changing times at Glaxo?

I think not


Bob Fiddaman.



[1] Changing times: GSK sells bad with good to doctors in safety push

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.

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

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

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

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

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


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


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



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


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


Viehbacher is now Chief Executive Officer at Sanofi.


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


A different era?

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

Two words - Marketing and Respiratory. Alarm bells anyone?


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

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

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

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

Can someone please hand me a vomit bag!

Related:

GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint




Fid

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