Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, May 29, 2014

GSK's Sales Reps Want Their Money Back

Where's John Grisham when you need him?

Seriously, you really couldn't make this shit up.

The Financial Times are running with a story that's as jaw-dropping as anything I've read thus far regarding the bribery scandal in China. I had to do a double-take, had I fallen asleep last night and somehow travelled back in time to April 1st? There were no skid marks from DeLorean tyres in my bedroom and my computer told me it was 29/05/2014.

"GSK salesmen want ‘bribes’ reimbursed" is the headline, what follows is pure Grishamism.

GlaxoSmithKline, the UK pharmaceutical company at the centre of a Chinese corruption scandal, is facing protests from junior employees who say the company is refusing to reimburse them for bribes they were ordered to pay by their superiors.
Now some Chinese sales staff are complaining that GSK has denied bonuses, threatened dismissal or refused to reimburse them for bribes they say were sanctioned by their superiors to boost the company’s drug sales. In some cases, managers instructed them to purchase fake receipts that were used to cover up bribes paid in cash or gifts to doctors and hospitals, according to salesmen interviewed by the Financial Times.
In some instances, managers disguised their involvement by using their personal email address to instruct staff to pay bribes and by ordering junior staff to claim on their personal expense accounts – even if the bribe was actually paid out by the manager – according to these people.
In late March, disgruntled staff sent 25 representatives to GSK’s headquarters in Shanghai, where they unfurled a banner that read: “Return my hard-earned money.”

Cor blimey governor, can you Adam and Eve it!

So, let's get this straight.

Glaxo's reps paid bribes out of their own pockets that were later to be reimbursed by the company...and now they are telling Glaxo that they want reimbursing?

Here's the Financial Times again...

“The expenses were paid with our own money, and although the receipts were not compliant, it was our managers who told us to buy the fake receipts,” said one former GSK salesman.

The FT article goes on to explain that some sales reps were warned not to implicate senior staff, in many instances, according to the FT,  management "approached each person [rep] before they were questioned and asked them not to mention his name. He even prepared a story for them to tell the investigator.”

Glaxo have denied that this is a systematic problem throughout their global operation - they've even denied it after other allegations of bribery have surfaced in other countries, namely Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and now the UK. [back story]

We hear the same old line from GSK when they have been caught by investigating officials, citing that they will "cooperate fully with investigators".

I thought long and hard about this line. It's pure psychology. By stating that they will cooperate fully with investigators eases the guilt and, at the same time, paints a picture that Glaxo were unaware what was going on. In essence, "We will cooperate fully with investigators", actually means we've been caught red-handed and will answer any of your questions. We will not offer you any specific evidence unless you ask for it specifically. Glaxo do the same when faced with litigation too.

I find it laughable that reps who knowingly broke rules with their own money now want reimbursing. It's akin to the Yorkshire Ripper billing the tool shop where he purchased his hammer from. Apologies for using such a heinous crime as an analogy - I'm referring to the Yorkshire Ripper and not Glaxo's bribery.

It's been alleged that female sales reps were told to offer sexual favours to doctors in efforts to get them to prescribe more of GSK's drugs. [back story]

Are we to assume then that these female reps will be asking for reimbursement of the contraceptives and/or mouthwash they purchased?

The UK's Serious Fraud Office recently announced that they are investigating GSK. It's highly likely that they will just focus on GSK's illegal activities overseas and won't even bother to look to see if GSK reps have been doing the same here in the UK.

The FT article can be read here. You may have to subscribe to read all the content.

Bob Fiddaman

Wednesday, May 28, 2014

Another Paxil Suicide Adds to Glaxo's Woes

Back in March I wrote about the suicide of Stewart Dolin.

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".
Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.
Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.
The complaint alleges that Dolin, "exhibited classic symptoms of akathisia immediately before his death. A nurse alleged to have been on the platform at the same time as Mr. Dolin noticed that Mr. Dolin was “very agitated, pacing back and forth and looking down the tracks.”

Last night Dolin's widow, Wendy, appeared on NBC TV in the US. The interview shows the lengths pharmaceutical companies, in this case Mylan and GlaxoSmithKline, go to protect the name of their brand.

The case, in a nutshell, sees Glaxo argue that Dolin took the generic form of Paxil manufactured by Mylan therefore they were not responsible for the side effects [suicide] The warning on the labelling was insufficient as it did not contain the risk of increased suicidality for adults over the age of 24. Mylan have argued that the product information was written by Glaxo therefore they are not responsible.

Classy huh?

Here's the interview with Wendy.

Bob Fiddaman

A Message From the UK Serious Fraud Office re GSK

GlaxoSmithKline plc investigation

27 May 2014

The Director of the SFO has opened a criminal investigation into the commercial practices of GlaxoSmithKline plc and its subsidiaries.

Whistleblowers are valuable sources of information to the SFO in its cases.  We welcome approaches from anyone with inside information on all our cases including this one - we can be contacted through our secure and confidential reporting channel, which can be accessed via the SFO website.

Notes to editors:

The SFO's secure reporting channel can be accessed here: or via our website home page,
The Serious Fraud Office is an independent government department responsible for investigating and prosecuting serious and complex fraud, bribery and corruption. It is headed by the Director, David Green CB QC, who exercises powers under the superintendence of the Attorney General. These powers are derived from the Criminal Justice Act 1987.

The SFO Press Office can be contacted on or 020 7239 7316 / 7004 (out of hours: +44 (0) 7557 009 842)


I actually went out and purchased a bottle of wine last night on the strength of this latest news.

The SFO may want to investigate the British drug regulator, The MHRA, too. It was they who, after a four-year investigation of GlaxoSmithKline, decided to let Glaxo off with a warning letter. No criminal charges were brought against GSK...even after the MHRA learned during their investigation that GSK had knowingly withheld safety data regarding children taking the antidepressant Seroxat [Known as Paxil in the US]

The MHRA's four year investigation into GlaxoSmithKline failed on a catastrophic level.

Alistair Benbow, who was then Head of European Psychiatry at GSK, claimed on National TV that Seroxat could be safe in children even though his company did not have a licence to recommend it to children. [1]

All the SFO need to do is request disclosure from GSK. Emails, documents and, more importantly, the notes taken by GSK's pharmaceutical reps during their visits to doctors and psychiatrists. Did Glaxo's UK reps offer the same incentives to British doctors as GSK's American, Chinese, Polish and Iraqi reps did?

Once they have these in their possession then I'm sure they will be able to retrace who said what and who they said it to.

It is imperative that the SFO obtain these documents.

The MHRA should have requested the same documents but why would they? They rely on pharmaceutical money, in fact, they are fully funded by the pharmaceutical industry.

The SFO are calling on whistleblowers - good luck. The carrot being dangled isn't really as attractive as the carrot dangled in front of whistleblowers in the US.

I suspect the SFO are merely following up on the alleged bribery in China - they need to do more than follow-up though.

GlaxoSmithKline is infested, it's driven by a culture where sales mean everything.

I do hope the SFO turn over every item they come across, I do hope this is not just them following up on GSK's foreign violations.

There are plenty of experts out there who could help the SFO's investigation, whether they choose to use them is another matter.

No stone unturned is the order of the day here. The SFO will, no doubt, face tough opposition from the current UK government. Deals may be struck given that Glaxo's chairman, Andrew Witty, and the current Prime Minister, David Cameron, are friends and business acquaintances. [2]

One thing is certain though. The eyes of the world are watching.

Bob Fiddaman

[1] Seroxat - The Liars? [Video]

[2] Cronyism, Chinese Style

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

When Psychiatry is Debated, it Becomes an 'Attack'.

Mommy, make them stop!

I laughed hard upon reading a recent article published in The Lancet Psychiatry [27 May 2014

You see, there's a bunch of psychiatrists who are taking umbrage to those that oppose unwarranted use of antidepressants. The psychiatrist argument smacks of total hypocrisy and lacks any scientific data, preferring instead to quote hearsay whilst using the defence of antidiagnosis and antitreatment groups attacking their belief system [because that's all it is, a belief.]

What's remarkable about this article is pretty much summed up in its final paragraph. My thoughts on this later.

Here we have 5 professionals putting their name to an article, namely, David J Nutt, Guy M Goodwin, Dinesh Bhugra, Seena Fazel and Stephen Lawrie.

They claim they are being targeted by an anti-psychiatry movement when, in fact, they are being asked to debate the issue of antidepressants publicly.

This latest stunt from David J Nutt et al just highlights how psychiatry, when backed into a corner, does everything to avoid going head to head in a public forum with people that disagree with them.

Rather than enter into a public debate they choose to deflect their cowardice by playing the victim.

"Psychiatry is used to being attacked by external parties with antidiagnosis and antitreatment agendas."

"Most of these people are depressed and more than 70% are not taking an antidepressant at the time of death. Blanket condemnation of antidepressants by lobby groups and colleagues risks increasing that proportion"

"Antipsychiatry groups usually claim that depressed patients should be treated with exercise and psychotherapy instead of drugs. However, little controlled evidence exists to support the use of psychotherapy as an alternative to antidepressants in major depression."

"...the anti-psychiatry movement, although now long in the tooth, has revived itself with the recent conspiracy theory that the pharmaceutical industry, in league with psychiatrists, actively plots to create diseases and manufacture drugs no better than placebo."

Nutt et al are so far of the mark here. There are many individuals, myself included, who are not part of groups - choosing instead to go it alone, to speak out against something because it's the right thing to do.

What I find worrying about this article is the bare-faced cheek of it's authors who dismiss claims that the pharmaceutical industry is in league with psychiatrists and then, because the Lancet abide by transparency, reveal the authors ties to the industry.

{Insert canned laughter here}

DJN has received grants and personal fees from Lundbeck and GSK; and personal fees from Lilly, BMS, Otsuka, Servier, and Pfizer. GMG has received grants and personal fees from Servier and Lundbeck; personal fees from Teva, Otsuka, Takeda, Eli Lilly, Merck, GSK, and AstraZeneca; and grants from P1vital. SL has received research funding from Abbvie, Roche, and Pfizer in connection with genetic, brain imaging, and therapeutic studies of people with schizophrenia. He has also been paid by Janssen and Roche to speak at or chair educational meetings about schizophrenia, as well as to contribute to advisory boards about new antipsychotic treatments. The other authors declare no competing interests.
It's laughable.

It's akin to the following hamster claiming that he doesn't know where the carrots are.

And we, the gullible public, are expected to believe Nutt et al because [boo hoo] they are being targeted by antipsychiatry groups.

If Nutt had anything about him, he'd step up to the plate and publicly debate what he thinks he knows about antidepressants and their safety - instead he, with his colleagues, run to the Headmaster because they cannot answer their critics in a public place - ergo they are being bullied, targeted by academics who have different opinions.

"Mommy, make them stop."

A few weeks ago Professor Peter Gøtzsche, Nordic Cochrane Centre, Dr Joanna Moncrieff, University College London and Dr James Davies, University of Roehampton challenged Nutt et all to an open debate. All three are part of The Council for Evidence Based Psychiatry [CEP] - the clue to what they seek is in the title of their organisation - "Evidence Based Psychiatry".

One way to put a stop to this is to stop the pissing match. Go public, sit on a panel - Gøtzsche et al on one side of the table, Nutt et al on the other side.

What we are currently witnessing is fight-hype, we see this, normally in Boxing. Two fighters talk the talk before beating one another in the ring. Difference being, they get in the ring to iron out their problems.

The CEP have challenged Psychiatry but Psychiatry is making excuses, they want to keep their heavy-weight belt and fear they will lose it if they accept the challenge.

We have the CEP in one corner here and Nutt et al in another. The CEP are ready to exchange blows but Nutt et al want protection from the referee. "The CEP are anti-me Mr Referee, do I have to fight them?"

In 2004 Nutt held 300 shares in GlaxoSmithKline and was also a paid consultant for them. It's a pity Nutt didn't add this in his article in the Lancet.

The Lancet Psychiatry article, Attacks on antidepressants: signs of deep-seated stigma?, can be read here [registration needed]

Bob Fiddaman

Friday, May 23, 2014

Blind Date With Vanda's Hetlioz

An American friend of mine sent me an email the other day. She told me how she had seen an ad aired on TV for a drug called Hetlioz (tasimelteon). Apparently, it's a pill to help those who suffer with Non-24-hour Disorder.

I admit I had to look this disorder up. My first thought was, Christ! They want to treat people who refuse to watch Kiefer Sutherland's character Jack Baur in FOX TV's 24?

Alas, I was wrong.

Non-24-hour Disorder, according to Hetiloz manufacturers, Vanda Pharmaceuticals, is...

... a chronic circadian rhythm disorder that occurs when individuals are unable to synchronize their endogenous circadian rhythm to the 24-hour day. Non-24 is most commonly found in blind individuals lacking the ability to perceive light, the primary environmental cue for synchronizing the circadian system daily. In general, individuals with Non-24 suffer from a variety of clinical symptoms as they cycle in-to and out-of phase resulting in disrupted nighttime sleep patterns and/or excessive daytime sleepiness.

Vanda had to convince the American drug regulator, the FDA, that their drug worked and was safe through a series of clinical trials. These trials have been slammed.

For instance...

  • The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced


  • The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

  • Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

  • Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.


Despite all of the above, Hetiloz was approved by the FDA earlier this year.


Now there's a word.

Astroturfing is the practice of masking the sponsors of a message or organization (e.g. political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s). It is a practice intended to give the statements or organizations more credibility by withholding information about the source's financial connection.

Step forward The National Sleep Foundation.

Trawling through their website I learned that their Non-24-Hour Sleep Wake Disorder section is sponsored by Vanda Pharmaceuticals. I flicked the following email to Vanda...

Dear Sirs,
Many pharmaceutical companies are now suggesting that they are going to be more transparent in regard to clinical trials and sponsorship's etc.
I noticed that the sleep foundation have a section on their website that is sponsored by Vanda Pharmaceuticals.
As a matter of public interest could you tell me if this was a financial arrangement, if so, how much?

In typical Pharmafia fashion Vanda did not reply, opting instead to check me out [fig 1] - Click image to enlarge.

Fig 1

I posed pretty much the same question to the National Sleep Foundation via their Twitter page. [Fig 2]

They had the decency to answer me but didn't really answer the question I put to them.

Fig 2

Not related in any way to Vanda?

Here's the sponsored section on the Sleep Foundation's website [Fig 3] - Click on image to enlarge and read the bottom left of the image.

Fig 3

Alternatively, click here.

I pressed the Sleep Foundation for an answer - to date, they have failed to respond.

I dug a little deeper regarding Vanda's drug Hetiloz.

In July 2013 it was reported that Vanda Pharmaceuticals Inc. were facing at least one shareholder lawsuit surrounding late-stage trials for the company's sleep disorder drug Hetiloz.

In one class-action complaint, Small v. Vanda Pharmaceuticals Inc. et al., it's alleged that Vanda and its officers issued materially false or misleading statements about Tasimelteon’s efficacy and the results of its Phase III clinical trials. Specifically, it is alleged that Vanda changed the design of the  primary Phase III study several times, including a complete replacement of the primary endpoint  one month before results were announced, because the company was in possession of data suggesting that the original primary endpoint was not going to be met; used a replacement primary endpoint that had never been used before in sleep-drug clinical trials and was not endorsed by the FDA; enrolled patients in the Phase III trials by “stretching” the clinical definition of Non-24; and combined data from two Phase III studies in order to demonstrate a benefit for Non-24 patients, where the two Phase III studies failed individually.

The full complaint can be read here.

Amazing that the FDA went ahead and gave a licence to Hetlioz... then again, the FDA are basically an extension of the pharmaceutical industry.

Non-24-hour Disorder is a new one on me. As for the treatment of it, Hetiloz, experiments with rodents revealed fertility impairments, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the "human dose". [1] [2]

I can only presume that these warnings will be printed in braille for expectant blind mothers?

Then again since when have pharmaceutical companies protected their patients?

Bob Fiddaman 

Blind people need all the facts too


[2] Side Effects Drug Center: Hetlioz Warnings and Precautions". RxList. February 10, 2014. "In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically."

You can follow the National Sleep Foundation on Twitter here.


Wednesday, May 21, 2014

Mental Disorders Are Contagious

I've found proof that mental disorders are contagious.

It's a shocking revelation, I know.

But as a writer, who is pretty much against the use of psychiatric medications, I feel I must relay this information.

I've trawled through hundreds of case files and found a common link that unquestionably proves that mental illnesses are contagious.

I'm surprised this has not been picked up before.

You see, it's quite simple really.

Take 100 patients with varying degrees of social problems ranging from financial worries, sexual problems, relationship problems etc.

Take 100 psychiatrists with varying degrees of clinical experience.

Each patient visits 3 different psychiatrists.

Patient 1 sees 3 different psychiatrists. He/she is diagnosed with 3 different mental disorders.

All patients are diagnosed with brain diseases, some have more diseases than others.

100 patients, who remember just had social problems going on in their lives, each now have a mental disorder or a number of brain abnormalities.

Each illness has been passed on by their psychiatrist.

Ergo - Mental Disorders are contagious.

Signs that show you may have been contaminated.

Keep a lookout for:

1. Various forms of paraphernalia dotted around your psychiatrist's office that advertise pharmaceutical products or companies. Things like mouse-mats, cups, umbrella's, writing pads etc.

2. Check your prescription, if it has the brand name of the drug then it's highly likely that your psychiatrist is a carrier of a mental disorder.

3. Carriers are often in denial. If you question their diagnosis they will talk down to you and tell you not to believe everything you read on the Internet.

4. Carriers often stutter and blush when you ask them for evidence of the mental disorder they have labelled you with.

5. Carriers are often invited to drug company presentations (also known as symposiums). Ask your psychiatrist if they have ever attended any such event.

6. Carriers often tout the chemical imbalance theory. They claim you have one that is causing your mental disorder. Ask them for proof of this, if they can't show you then they have more than likely been infected with a mental disorder themselves.

7. Carriers often play down the risks of the drugs they prescribe you. Ask them...

If the drugs are addictive.

If the drugs can induce homicidal acts.

If the drugs can induce suicide or suicidal thoughts.

If the drugs can increase psychosis.

If the drugs can increase birth defects.

If they answer 'no' to any of the above then the likelihood is that they have been infected.

8. Carriers often suggest that your mental disorder is in your genes. Ask them for scientific proof of this. If they stall, stutter or blush then, chances are, they have been infected.

9. If you are a woman who is pregnant carriers will suggest that your mental disorder will be passed on to your fetus if you do not treat your brain illness. Ask them for scientific proof of this. Refer to # 4.

10. If you spot a copy of The Diagnostic and Statistical Manual of Mental Disorders (DSM) then it's highly likely that your psychiatrist has been infected.

All we need now is some sort of immunization.

No drugs just plain common sense.

Steer clear of the psychiatrist's office.

Bob Fiddaman.


Logic in the Human Brain - From the Journal of Common sense

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'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

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"."

Reilly, it is claimed, pressed his sales team to pay doctors, hospital officials and health institutions to use GSK products, resulting in the "illegal revenue" of hundreds of millions of dollars. He is also suspected of bribing government officials in Beijing and Shanghai.

Reilly left China before Chinese authorities started their investigation but returned to assist Chinese authorities with their inquiries.

Four other GSK employees, namely; legal affairs director Zhao Hongyan, vice president and operations manager Liang Hong, human resources director Zhang Guowei, and business development manager Huang Hong were arrested in 2013. Hong had already gone on Chinese television and admitted to the crimes and explained how the scheme worked, including the use of fake conferences and travel agencies to create receipts for services that were never performed. The surplus funds were allegedly then used to pay bribes.

In August 2013  China’s official news wire, Xinhua, quoted a 35-year-old female medical representative who reportedly worked for a GSK regional sales manager named only as Mr Li.

The woman, named as Ms Wang, said “some executives gave clear directives to the sales department to offer bribes to doctors with money or opportunities to attend academic conferences.”

Ms Wang said she would even go so far as fulfilling some doctors’ “sexual desires” in order to “meet their needs” and persuade them to prescribe more drugs."

GSK's CEO Andrew Witty, who last year played down the $3billion fine slapped on his company for kickbacks and promotion of drugs off-label, must be totally embarrassed by the current state of affairs at Glaxo.

Witty, now claims that the allegations appear to be true and feels.“personally deeply disappointing,”

Witty, of course, wouldn't be Witty if he didn't play down the allegations.

He claims that 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.”

In other words GSK's control mechanisms simply don't work, a bit like the drugs they manufacture, huh?

Back in December Witty joined British PM David Cameron on a trip to China (probably an attempt to douse the flames on the Chinese allegations.) [Back Story]

Bob Fiddaman


Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Andrew Witty... I know narrrrrrrrthing

葛兰素史克公司 腐败 For Researching Chinagate

Glaxo's Private Investigator Arrested

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing - Part II

Hammer to Fall on GSK's Chinese Executives

Thursday, May 08, 2014

Brazil Suspends Sale of GSK's Paxil (Seroxat)

The National Health Surveillance Agency (ANVISA) have temporarily suspended the sale of GlaxoSmithKline's antidepressant Paxil.

ANVISA are the Brazilian drug regulatory agency who regulate the drugs Brazilian citizens are prescribed.

GlaxoSmithKline sent ANVISA correspondence stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues.

It's unknown where the contaminated batches originated from. The batches recalled are:

SH0040V (manufacture date, June 2013, and expiration date, June 2015),
RK0084V (manufacture date, August 2012, and expiration date, August 2014),
RJ0220V (manufacture date, July 2012, and expiration date, July 2014),
RJ0219V (manufacture date of July 2012, and expiration date, July 2014),
RC0113V (manufacture date, March 2012, and expiration date, March 2014)
RC0113V1 (manufacture date, March 2012, and expiration date March 2014).

Last month GSK Ireland were sent a warning letter from the FDA listing a series of violations regarding the state of their plant in Currabinny, Carrigaline, Cork. Paxil had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

Back in 2010 Glaxo plead guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.

Bob Fiddaman

Tuesday, May 06, 2014

CEP Lays Down Gauntlet to Prescribing Psychiatrists

Will Professor Nutt et al accept the invitation from the CEP for a debate on antidepressants?

The Council for Evidence Based Psychiatry [CEP] has laid down the gauntlet to a handful of psychiatrists who, it appears, believe antidepressant use can prevent suicide.

Last week Professor David Nutt, Professor Sir Simon Wessely and other senior psychiatrists responded to an article in The Times written by  Health Correspondent, Chris Smyth.

Smyth quoted CEP Co-Founder Peter Gøtzsche in his article and this evoked a response from a number of psychiatrists who replied in a letter to The Times.

Sir, Depression can be a debilitating and lethal illness. Medication is a vital part of the treatment of the severest cases. Successful treatment with antidepressants definitely does not do “more harm than good” as you report (Apr 30).
We do not dispute that these drugs are of potentially less value for mild depression, but their effectiveness is maintained as the severity of the depression increases. Is that true of psychological treatment or exercise?
Depression is serious: 6,500 people commit suicide each year in the UK. Many of them are never offered antidepressants, and the blanket condemnation of antidepressants by Professor Peter Gøtzsche and colleagues will increase that proportion.
Professor David Nutt, Neuropsychopharmacology Unit, ICL
Professor Stephen Lawrie, Division of Psychiatry, Edinburgh
Professor Sir Simon Wessely, Royal College of Psychiatrists
Dr Seena Fazel, University of Oxford
Professor Guy Goodwin, European College of Neuropsychopharmacology
Professor Dinesh Bhugra, World Psychiatric Association

In response to the letter from Nutt et al, Peter Gøtzsche,  Dr Joanna Moncrieff and Dr James Davies, of the CEP, wrote...

Sir, Further to the letter from Professor David Nutt and others, whatever the evidence on the efficacy of antidepressants — and the effects are weak even in severe depression — there is no doubt these drugs are being widely overprescribed, and not enough attention is being paid to the harms they can cause. We do not accept that reducing antidepressant prescribing will increase the number of suicides. Antidepressants have not been shown in reliable studies to reduce suicide, indeed they increase the risk of suicide in young people. There is also evidence that antidepressants may increase a whole range of adverse events in the elderly, including falls and fractures, and are associated with increased mortality.
Given these factors and the tendency of many psychiatrists to downplay the harms of overprescribing such medications, we invite Professor Nutt and his colleagues to a public debate where these views can be properly aired.
Professor Peter Gøtzsche, Nordic Cochrane Centre
Dr Joanna Moncrieff, University College London
Dr James Davies, University of Roehampton

Nutt et al have, so far, failed to reply to the invitation. I'd be really surprised if they take the gauntlet laid down by Messrs Gøtzsche, Moncrieff and Davies - Nutt et al have been backed into a corner here - if they come out with guns blazing they are liable to make themselves look silly. Using the defence that antidepressants prevent suicide in their initial letter to The Times was  textbook psychobabble. They go down this route in the hope that patients, both past and present, support their claims with statements such as "Antidepressants saved my life" or "If it wasn't for antidepressants I'd probably be dead". Both statements come from the type of patient who, for whatever reason, have been duped into believing the claims of clever marketing, key opinion leaders [paid by the industry] and a fear that they just cannot get through the day without their daily fix of Prozac type drugs.

Nutt et al have now been publicly challenged to offer proof of this. To my knowledge, there is no proof that antidepressants can prevent suicide, in fact the evidence suggests that antidepressants actually can induce suicide.

Hats off to the CEP for showing how predictable the pro-pill brigade can be when one questions the safety and efficacy of antidepressants.

Incidentally, I wrote about David Nutt some years ago. Nutt was part of the Committee on the Safety of Medicines (CSM), an apparent independent body who have, for 40 years, advised the UK Licensing Authority on the quality, efficacy and safety of medicines - In other words they offered advice to the MHRA.

In 2004 Nutt held 300 shares in GlaxoSmithKline and was also a paid consultant for them. It's a pity Nutt didn't add this in his letter to The Times.

So, does Nutt have the bottle to get into a public debate about the safety of antidepressants?

Will he shy away because of his paid consultancy from GlaxoSmithKline and the shares he once held may be used against him and make his argument very weak. Will he and his colleagues be able to back up their claims with actual science or are their claims, as I suspect, just a theory based loosely around the pandemic promotion of these groups of medicines.

We have six pro pill pushers in Nutt, Lawrie, Wessely, Fazel, Goodwin and Bhugra. How long will we have to wait before the likes of Robert Gibbons and Patricia Casey poke their noses into something that appears to have upset those who choose to drug rather than look at the evidence that, for the majority, shows that these drugs just don't work.

My money is on Nutt et al declining the offer of a public debate. Why would they accept the offer to be publicly humiliated by scientific fact?

You can see the exchange of letters between the CEP and Nutt et al here.

Bob Fiddaman

Sara Carlin, 7 Years On.

Sara Carlin

On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.

Sara's case was the first Paxil related suicide story I covered extensively, in fact it was the first of any of the antidepressant suicides I covered.

I've since been to see Sara's mom and dad, Neil and Rhonda. I've been to visit Sara's resting place and had a private moment with her.

Sara's story struck a chord with me and I almost felt compelled to write about her, sometimes staying up until the small hours, just to make sure I had my facts correct.

It's 7 years today since Sara left us. I am in no doubt that her suicide was induced by the Paxil she was taking. I am in no doubt that her inquest was used by lawyers and the Coroner as a means to defend Paxil and not to highlight how dangerous it can be. I dubbed the inquest, 'Glaxo & Friends Vs The Carlin Family', the duration of the inquest, the witnesses called defending Paxil and the way they played down its propensity to induce suicide proved me right to label it in such a way.

The Coroner, the witnesses, the lawyers and, to an extent, the mainstream Canadian press, all made sure that Sara's voice would be suppressed. For that they should be totally ashamed of themselves.

Sara was another victim who fell to the Paxil promotional pandemic, a pharmaceutical company and it's lust for greed took Sara away from her mom, dad, sister, brother, relatives and friends... and once again, in the shape of lawyers representing them at Sara's inquest, they [GlaxoSmithKline] denied any wrong doing.

The outcome saw the jury make recommendations. To date, not one single recommendation has been put in to place. This is not only disrespectful, it also makes a mockery of the coronial system and puts other lives at risk.

The tragic death of Sara has, I'm sure, helped others. It was a high profile case and Canadian doctors would have been careful not to prescribe Paxil during the time the Canadian press were reporting about her.

I created the following video for Sara back in 2009, before the outcome of her inquest. I sat on it for a number of months before making it public. It's sad, so very sad. To date, the video has had almost 15,000 views.

Quite fittingly, on the 6th May 2012, my granddaughter, Ruby, was born to my son and his wife. Five years, to the day, that Sara left us.

Nessun dorma (None shall sleep) Sara.

You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline



SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?

Sara Carlin Inquest - We Know How, Now Tell us Why!

**Exclusive - Sara Carlin Inquest - Jury Returns With Recommendations.

Sara Carlin Inquest - The Influence of Terence Young

Bob Fiddaman

Friday, May 02, 2014

Stevie Young Hooks Up with AC/DC in Vancouver

Stevie Young (right)

AC/DC are a huge part of my history, hence the reason I tend to post about them every now and again on this old blog of mine which is, in the main, a blog regarding the dangers of antidepressant medications.

A few weeks ago there was speculation surrounding the future of AC/DC after it was reported that Malcolm Young, rhythm guitarist, was too ill to continue playing.

Speculation has been rife regarding a replacement for Malcolm although it was pretty obvious, to myself and many hardcore Acca Dacca fans, that there could only be one replacement.

Stevie Young (nephew of Angus and Malcolm) stood in for Malcolm on AC/DC's 1988 tour of North America. At the time, Malcolm needed a rest.

Stevie, it appears, has now joined up with Angus and the rest of the band (minus Malcolm) in Vancouver where they will be entering the studio to record a new album.

I saw Stevie Young many years ago in Birmingham. The Starfighters, whom Stevie played rhythm guitar for, played a set at Romeo & Juliet's, a nightclub in Birmingham. I remember it well as the band distributed free singles at the end of the gig.

Late last night a photograph (above) was being circulated around the social media network sites that showed Angus and Stevie sitting together.

Brendan O’Brien, who produced AC/DC's 2008 album, Black Ice, will be producing AC/DC's new album.

Here's a taster of Stevie Young at work, ironically this is the single The Starfighters gave away when I saw them many years ago in Birmingham.

Good to see a Brummie living the dream.

Best of luck Stevie.

Latest news... **Rock or Bust - AC/DC New Album**

Related - AC/DC Legend Retires

Bob Fiddaman.

Please contact me if you would like a guest post considered for publication on my blog.