Zantac Lawsuit

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

Tuesday, July 30, 2013

Witty's Wok Emporium

If a picture paints a thousand words...

Click image to enlarge

Back story here

Bob Fiddaman

Thursday, July 25, 2013

Witty Plays Down China Scandal

"...the company’s own investigations have found that the extent of the bribery scandal is significantly less than what the Chinese government contends." - Andrew Witty, GSK CEO

Trouble is escalating in China over the GlaxoSmithKline kickback scandal. Never fear though, GSK's CEO and former Zyban spin doctor, Andrew "all part of an era" Witty, is on hand to douse the flames.

The Chinese government have accused British pharmaceutical giant, GlaxoSmithKline, of paying almost $500 million in bribes, mainly to doctors who prescribed its products.

That's some allegation and one that has been denied robustly by GSK.

This coming on the back of Glaxo's $3billion fine in the US last year, a fine paid at the end of years of robust denial that they did anything wrong.

Hmmm, you see a pattern here?

China's Ministry of Public Security are alleging that the British giant siphoned an estimated $489 million in bribes through almost 700 travel agencies with the intention to influence doctors to prescribe more of their drugs, this practice is more commonly known as 'kickbacks'. Glaxo, it's alleged, also arranged for doctors to receive sexual services from prostitutes. Ooo er, Fried Tofu Curd Balls, anyone?

After initial denial Glaxo are now claiming that senior China executives acted outside of its “processes and controls” and broke Chinese law. Just Chinese law then?

Chinese authorities have arrested four 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. Hong having already gone on Chinese television and admitting to the crimes and explaining 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.

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?

Witty, using his much beloved spin, also claimed that he still believed GlaxoSmithKline controls are robust, and the company’s own investigations have found that the extent of the bribery scandal is significantly less than what the Chinese government contends. Well, they would Andrew wouldn't they. If Glaxo investigate Glaxo for crimes then Glaxo will be vindicated. It's akin to a serial killer investigating his own behaviour and concluding that although he went on a four year murdering spree it wasn't as bad as prosecution was alleging.

More on Witty's statement HERE


Monday, July 08, 2013

Glaxo Face Botox and 'Moobs'Lawsuits

Ahem, was just part of an era

There's something about this company that really makes me laugh.

Coming on the back of Andrew Witty's infamous "It was just part of an era" comment regarding the $3billion fine slammed down on his company, comes yet more shenanigans, this time in China where Glaxo are accused of bribing doctors with cash and other perks for prescribing Botox and tried to cover their tracks by using private email.

It's alleged that Glaxo's sales staff in China were instructed by local managers to use their personal email addresses to discuss marketing strategies related to Botox. In the personal emails, sales staff discussed rewarding doctors for prescribing Botox with cash payments and other rewards.

All of these shenanigans, according to a whistleblower, went on between the years 2004 and 2010 - still, all part of an era eh Andy?

More here.

Just as the dust settled on that breaking news comes another lawsuit against the British pharmaceutical giant.

Law360, the online subscription service for the legal profession, is reporting that a GSK sales director is claiming he was fired for being a man.

Joseph Cappellino filed his suit against GSK in the Superior Court of New Jersey on June 14.

Cappellino claims that he was pushed out and replaced by a young woman who, to his knowledge, had no sales management experience.

The case is Joseph Cappellino v. GlaxoSmithKline LLC, et al., case number L-001643-13

Poor guy but he must surely know how Glaxo operate?

If bribes don't work then maybe a pair of tits will.

Speaking of which...

I see Witty's good friend, Deidre Connolly is making the kind of promises that Witty made after the $3billion fine. In an interview with the New York Times Connolly describes how both she and Witty shared coffee [how romantic] after she had read an article about him.

Soon after that meeting Connolly joined forces with Witty.

She told the NYT, "Our company is facing a changing health care market that demands higher-quality care, lower costs and better outcomes. As part of rethinking and redesigning our commercial model in the United States, we have revamped our procedures for training, evaluating and compensating our 5,000 sales people.

"This was under way when, last year, the company paid $3 billion in fines to the federal government because it had earlier promoted some antidepressants for unapproved uses and failed to report the status of studies about our diabetes drug. We are committed to ensuring that this never happens again."

Ha! it was much more than promoting antidepressants and failing to report studies or was that spin at work, you know, hiding that one little word 'fraud'. Connolly failed to mention the kickbacks her company gave to doctors and, according to China, it's still very much a pastime of GSK sales managers and reps.

GlaxoSmithKline are a British pharmaceutical company who operate globally, they proudly boast to improve the quality of human life by enabling people to do more, feel better and live longer... the Chinese doctors would certainly agree with that!

Bob Fiddaman

Friday, July 05, 2013

Coroner Slams One Suicide at Capital and Coast DHB

The New Zealand Herald are reporting that Coroner Garry Evans has slammed Capital & Coast District Health Board for its inadequate treatment of a man who killed himself after being discharged from Wellington Hospital.

This is quite a deal in New Zealand as Coroners rarely allow reporting on suicides... apparently reporting on suicides makes people want to go out and kill themselves. Yeh, right.

39-year-old Bryan John Eastwood was, as we've come to expect in these types of cases, given antidepressants to help his alcohol addiction and also to help him sleep. He'd recently separated from his wife and lost his job and was deemed to be 'anxious' by his prescribing healthcare professional.

The Herald writes:

"Two days later he went to his GP feeling "anxious and miserable" and was given anti-depressants and medication to help him with sleeping and alcohol withdrawal.
On March 13, Mr Eastwood went to Wellington Hospital's emergency department after overdosing on clonazepam and drinking up to 23 units of alcohol.
A risk assessment noted a number of concerning features including alcohol abuse, social isolation, the break-up of a significant relationship, the loss of his job and recent criminal proceedings.
Nonetheless, he was assessed as not wanting to die and, rather, the overdose was considered an attempt to get his wife's attention.
A nurse unsuccessfully tried to contact the on-duty registrar, but Coroner Evans said the telephonist may have been calling the wrong doctor.
The registrar was required to be contacted in such cases but Mr Eastwood was discharged anyway.
Nurses involved in the case commented that there was considerable pressure to discharge clients within six hours due to the hospital's "six-hour rule".

I find it odd that this poor man was deemed as just trying to get his wife's attention considering he was abusing alcohol, was in trouble with the law and was feeling socially isolated. I also find it bizarre that there's a six-hour rule in place for such cases.

Overdosing on a drug such as clonazepam could have been fatal, particularly combined with alcohol.

In the US clonazepam is better known by its brand name, Klonopin.

Former lead singer of Fleetwood Mac, Stevie Nicks, had a lot to say about the drug.  “[Klonopin] turned me into a zombie,” she told US Weekly in 2001. Nicks also described the drug as a “horrible, dangerous drug,” and said that her eventual 45-day hospital detox and rehab from the drug felt like “somebody opened up a door and pushed me into hell.” [1]

In 2009, Roche, the manufacturer of Klonopin in the US, issued a warning to prescribers of clonazepam stating that, "Roche would like to advise you of a recent change to the Klonopin Prescribing Information (WARNINGS and PRECAUTIONS sections). Based on pooled analysis of eleven antiepileptic drugs (AEDs) performed by the FDA, a class warning for increased risk of suicidality (suicidal behavior or ideation) is now required for all AEDs (including Klonopin)." [2]

Yay the coroner for allowing media reporting on this, he did so to promote public safety. Maybe though he should have dug deeper, he may have found that it was quite wrong to give such a drug to a vulnerable patient, furthermore, the drug in question, as admitted by its own manufacturers, increases the risk of suicidality.

As for Capital & Coast, they are under the radar with a recent request I made to all the DHB's in New Zealand.

I've learned from the data they sent me that between the years 2007-2010 there were 40 suicides from patients under their care, 37 of whom were on medication at the time of their suicides. 10 of those 37 were, coincidentally, taking clonazepam within the six months prior to their deaths.

If a member of the public can access information like this then I'm sure coroners can.

I'm just baffled why they don't.

Bob Fiddaman

[1] Is This the World's Deadliest Pill?
[2] Klonopin® Tablets (clonazepam) WARNING

Thursday, July 04, 2013

Panorama - Antidepressant Birth Defects

Earlier this week the UK flagship programme, Panorama, exposed the link between a group of prescription medications and birth defects. The programme, "The Truth About Pills and Pregnancy", highlighted the epilepsy drug, Epilim (Sodium valporate) and the group of SSRI drugs.

"The Truth About Pills and Pregnancy" focused on two of the SSRi group, namely Cipramil (citalopram) and Seroxat (paroxetine).

Much of what was covered by investigative journalist, Shelley Jofre, has been written about before but rarely do we get the chance to see this controversy on our TV screens.

I'm left wondering if prescribing physicians will see it as putting women off taking medications during pregnancy, this has a tendency to make GP's dig in their heels because professionals hate to be told that they are wrong, they hate to be told that there is research out there that they have missed... overlooked.

Panorama, once again, showed exactly how the pharmaceutical companies, in this case, Sanoi Aventis [Epilim], GlaxoSmithKline [Seroxat] and Lundbeck [Cipramil] deny any link between their products and birth defects. Jofre, who rose to fame for investigative work on Glaxo's Seroxat, also interviewed Dr June Raine, the MHRA's Director of Vigilance and Risk Management. In the past (Panorama Seroxat expose) the MHRA mouthpiece was Alasdair Breckenridge who performed less than adequately in front of camera. Did Raine perform any better? Not really, once again it was all spin and deniability.

The yellow card was touted once again, a system designed to collect adverse reactions to medicines and to protect the public from harm. I don't even believe the MHRA think their yellow card reporting system is robust enough to be the be and end all of dodgy medicines on the market. In any event, children born with defects are just unlucky, right? They are just unfortunate because... well, because shit happens.

Shit is only happening because it's shit that is in charge. However they spin it one must always remember that one cannot polish a turd, something the MHRA have been trying to do for years, particularly where SSRI's are concerned.

The antidepressant/birth defect link has been debated for years. We have those who claim untreated depression in mothers can harm the child, maybe so but there is no evidence that mothers taking antidepressants protect their unborn children by taking these drugs. Yet health professionals globally still prescribe them.

If an illness such as depression in an expectant mother can harm a foetus, does it harm them in such a way that they are born with heart defects, cleft palate or skull deformities?

These are physical changes to the human body caused by the chemicals ingested during pregnancy, we saw it with thalidomide and have been seeing, but ignoring, it for almost two decades with SSRIs.

I don't really buy into this tough decision health professionals have to make, this nonsense about weighing up benefits against risk just doesn't wash with me any more. They should not be weighing up benefit against risk when they don't even have the full facts to compare. Facts, such as the early rat studies [1979/80] carried out on paroxetine - those rats given paroxetine gave birth to pups who all died four days after they were born, while 80% of the pups not exposed to paroxetine were still alive on day four. Surely this should have rang alarm bells or, at the very least, warranted more animal studies. Fact is it didn't, it was brushed under the carpet, seen as something minor, shit happens, right?

When a pharmaceutical company carries out tests on animal subjects they sing from the rooftops when they see a benefit. When they see a risk they bury such data. They do not choose to weigh the two against each other, why would they wish to do something that could harm sales? Harming babies is okay though, just a small price to pay in this billion-dollar market.

Informed Decision

The phrase "informed decision" has been used many times throughout the past 10 years or so that I actually think we have got to the stage where it means nothing, it's just a phrase associated with campaigners, activists or conspiracy theorists. Many won't even know what it means or will accept information given to them by healthcare professionals as everything that needs to be known on the subject. Healthcare professionals tend to quote published studies to concerned patients, studies that have either been funded by the pharmaceutical industry or written by the pharmaceutical industry who later disguise that work as being written by somebody else, usually an expert. Experts who put their names to papers written by the pharmaceutical industry take the back-slaps, along with big payments for being a good sport. It's these weasels who convince doctors that taking antidepressants during pregnancy is quite safe.

One can only make an informed decision when one has all the facts. Truth is, patients never get all the facts - how can they when their own doctors don't?

"The Truth About Pills and Pregnancy" highlighted that almost 20,000 children could have been effected by the epilepsy drug, Epilim. Given that an estimated 1,000 were effected by thalidomide I think it's high time regulators removed their fingers from their backsides and grew a pair. Alas, this is just not going to happen. The MHRA rely on funding from pharmaceutical companies, they rely on expertise from pharmaceutical companies and, in many cases, employ ex-pharmaceutical employees, case in point Alasdair Breckenridge and Ian Hudson, both, at some point in their careers worked for GlaxoSmithKline, or Smith Kline Beecham as they were known then.

Doctors, for their part, maybe have a 10 minute window. A patient will present them with evidence, the doctor will tick boxes and then make a dignosis based on the number of ticks.

In New Zealand, for example, most doctors use PHQ-9, a patient health questionnaire, which carries 9 opportunities for doctors to tick boxes. The patient never gets to see this. Most of the questions relate to if the patient has a poor appetite to if they are overeating, if they are having trouble sleeping or sleeping too much, if they are having trouble concentrating etc. Most, if not all, the questions relate to all of us, probably even the doctor who is running the test on you.

So your doctor allocates you points based on your answers and his observations.

What may surprise many is that the PHQ-9 (patient health questionnaire) is copyrighted to pharmaceutical giants Pfizer, the company that manufactures and markets the antidepressant Zoloft (Sertraline)

Antidepressants are advertised on TV in New Zealand, the only other country that allows this is the United States. The 'other' types of adverts run on TV in New Zealand are letting the public know that it's okay to talk about depression. These ads have a famous face. Ex All Black John Kirwan being the most recent voice/face. Kirwan was, in 2007, appointed as an Officer of the New Zealand Order of Merit for services to mental health and I'm sure, whether he knows it or not, has helped the sales of antidepressant medication.

Taking antidepressants during pregnancy is a hot potato. For expectant mothers it's akin to playing Russian roulette. Their child may be lucky and be born defect free but this does not mean they are out of the woods.

Sudden Infant Death Syndrome (SIDS)

SIDS, more commonly known as cot death or crib death, is not a medical cause of death, rather a statement that the cause of death is unknown. In fact, SIDS, is yet another of those hot potatos as nobody can pinpoint why infants suddenly die when there is, apparently, nothing wrong with them. Some of the theories that exist have been debated and disproved. Bacterial infections, bed sharing, inner ear damage, Nitrogen dioxide exposure, toxic nerve gases emitted by mattresses, high levels of vitamin C have all been used as an explanation or reason for SIDS.

So, most of us know how horrific withdrawal can be on these drugs. We, as adults, have had to endure the electric zaps, tremors, akathesia, suicidal feelings when withdrawing from these drugs - do babies exposed to these drugs during pregnancy experience the same? It would be ridiculous to say that they don't given that smoking and drinking is not recommended during pregnancy because both these substances can harm your child.

The MHRA are having their cake and eating it folks. On one hand they have a clear conscience because they have already told doctors that SSRIs should not be given to children or adolescents because they may induce suicidal thinking in this population. In other words, the risk outweighs any benefit. They are failing miserably in protecting expectant mothers. What the MHRA seem to be forgetting here [conveniently] is that it's not just one person ingesting the medication, it's two and one of them falls into the very same category (population) that the MHRA, after many years of thumb-twiddling, found that the risk of antidepressant exposure far outweighs any benefit.

Now, tell me again, what benefit does a child growing inside its mother receive from an antidepressant, indeed, tell me, if you will, what benefit a newborn receives from breast feeding when traces of antidepressants have been found in breast milk?

If you are an expectant mother and still undecided about antidepressant use during pregnancy then this simple test should help you arrive at your decision. If you feel the need to bathe your unborn child in serotonin then drop a bronze coin into a glass of Coke and see what happens.

"The Truth About Pills and Pregnancy" can be viewed below. It may only be available on YouTube for a short period as the material belongs to the BBC. I made the decision to upload it for the benefit of viewers outside the UK who cannot access the BBC IPlayer.

Bob Fiddaman

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