Britains biggest corporate crook? – GlaxoSmithKline a clear winner

Here’s a take on the Glaxo scandal from today’s Guardian by Terry Macalister.

GlaxoSmithKline, Britain’s biggest pharmaceutical group, has been selling anti-depressant drugs in the US for unapproved uses on children, concealing critical evidence from US regulator the Food and Drug Administration (FDA) relating to a diabetes product, and offering lavish entertainment to doctors willing to promote its medicines.

The problems came to light because of whistleblowers inside the company and adds to a string of other settlements with pharmaceutical firms that lead critics to claim problems are endemic in the sector.

Last month, Abbott Laboratories was forced to pay $1.6bn over its marketing of the antipsychotic treatment Depakote, while the total cost of industry fines is over $20bn covering the last two decades.

But the GSK case has shaken even the most hardened of industry observers, as prosecutors found the company had been allotting over half a million dollars a year to its district sales representatives to offer doctors regular golf lessons, fishing trips, and basketball tickets while promoting the use of antidepressant drug Paxil in children. The GSK sales campaign also involved helping to publish an article in a medical journal that misreported evidence from a clinical trial.

Meanwhile the company was also being accused of marketing the drug Wellbutrin for sexual dysfunction and weight loss, when it had only received official consent from the FDA to treat depression. Some of its drugs reps were reportedly describing Wellbutrin as “the happy, horny, skinny pill”.

In the case of a third treatment, Avandia, the company did not report to the FDA studies it had carried out that showed there were safety concerns about heart risks. Critics had been calling for the drug to be banned four years ago yet it was only in 2010 that restrictions were finally slapped on its use.

What’s happened to the perpetrators?

GSK has agreed to pay a $3bn fine to settle criminal and civil charges with federal and state governments stemming from illegal activity over 10 years. This is the biggest-ever fine of its kind but there seem no plans at this stage to pursue executives or other individuals in positions of power at the time. Through some of the period covered by the fine, the firm was run by the highly paid Frenchman Jean-Pierre Garnier, whose entitlement to a £22m “golden parachute” payoff if he left the company enraged shareholders and caused a historic investor revolt.

In response to last week’s announcement by regulators, the pharmaceuticals company said it had changed the way its sales staff are paid by eliminating individual sales targets.

Sir Andrew Witty, GSK’s chief executive, said the settlement brought a resolution to “difficult, long-standing matters for GSK” adding: “I want to express our regret and reiterate that we have learned from the mistakes we made.”

Critics point out that other executives directly named as having been told of concerns continue in top jobs, albeit in different companies.

Whistleblower Greg Thorpe first alerted the company to the entertainment offered to doctors and the culture that allegedly put profits above ethics in 2001. He raised his concerns with David Stout, who was then head of the US business, and Bob Ingram, GSK’s chief operating officer. When he was forced out of the company, he took his case to the regulators, which spent almost 10 years investigating the issues.

Stout became a non-executive director of another London-listed pharmaceutical company, Shire, and Ingram is chairman of the biotechnology firm Elan.

What’s the public image of the industry?

Rock bottom, despite drugs firms’ best efforts. GSK’s corporate responsibility report runs to more than 100 pages, and details its pledges to improve access to healthcare in the developing world, and cut its carbon footprint. Witty insists: “We firmly believe that operating in a responsible and ethical way is essential for the success of our business.”

But after last week’s case, there can be little doubt that Big Pharma is top of the table for misbehaviour ahead of the arms industry, which has hogged the limelight for the past 100 years.

Some point to a long-running pattern of behaviour reaching back much farther than the most recent revelations. Eliot Spitzer, who as New York’s attorney general sued GSK over similar allegations eight years ago, told the New York Times that companies like GSK seem incorrigible. “What we are learning is that money [ie fines] do not deter corporate malfeasance. The only thing that will work in my view is chief executive officers and officials being forced to resign and individual culpability being enforced.”

Sidney Wolfe, a doctor and director of consumer organisation Public Citizen’s health research group, goes further: “Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients’ lives in danger.”

What’s the reality?

Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, which provides information for the pharmaceutical sector.

The fact that the profits available from bestselling drugs dwarf the fines handed out if anything goes wrong means the kinds of misdemeanours picked up in the settlement are bound to happen, says Wolfe. His conclusion is that, for Big Pharma, “crime pays”.

What’s the UK doing about it?

All of GSK’s problems have come to light in the US, where corporate abuse is taken very seriously. Britain is different, and the FDA’s equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), appears to engage in lighter-touch regulation. The MHRA has never successfully prosecuted a company since it was established nearly 10 years ago. It did investigate GSK over alleged inappropriate use of a drug in 2008 but abandoned the case. Since then, the total amount of fines imposed on individuals engaged in counterfeiting is £73,300. Confiscation orders under proceeds of crime legislation have totalled £18.9m and the MHRA says it has issued 467 warnings and 151 cautions.

They sold us ‘happy pills’ – but all we got was suicide and misery

Slowly the mainstream media is catching up with the Seroxat scandal – but Peter Hitchins of the Daily Mail has been writing about Seroxat for a while now.

I’d guess that either he, or someone he’s close to, has been through the Seroxat experience

This is his latest commentary on GSK’s record $3 billion fine for mis-selling, bribery and hiding negative drug trial data.

I’d like to suggest that his paper starts a camapign for a judge-led investigation into GSK and the Seroxat scandal – what do you think Peter?

Here’s the article:

A scandal can exist for ages before anyone notices. Here is one such. Ten years from now we will look back in shame and regret at the  way the drug companies bamboozled us into swallowing  dangerous, useless ‘antidepressant’ pills.

You’d be far better off taking a brisk walk. The moment of truth must come soon, though most of Britain’s complacent, sheep-like media will be among the last to spot it.

I would have thought it was blaring, front-page, top-of- the-bulletin news that GlaxoSmithKline, one of our biggest companies, has just been fined £2 billion (yes, you heard that right, £2 billion) in the US for – among other things – bribing doctors, and encouraging the prescription of unsuitable drugs to children.

Its drug Paxil, sold here as Seroxat, was promoted as suitable for teenagers and children, even though trials had shown it was not.

Doctors were sent on free trips where they were treated to snorkelling, sailing, deep-sea fishing, balloon rides and spa treatments (and cash payments), to persuade them to prescribe these drugs, or to reward them for doing so.

A medically-qualified radio host was allegedly paid more than £150,000 to plug one GSK antidepressant for unapproved uses. GSK paid for articles approving its drugs to appear in reputable medical journals.

It is well known now among doctors that other drug companies have suppressed unwelcome test results on modern antidepressants. These results show they are largely useless for their stated purpose. In many cases they were not significantly more effective than dummy tablets in lifting the moods of patients. Thanks to Freedom of Information investigations, the truth is now out.

Even worse than this is the growing suggestion that, far from making their users happy, these pills can increase suicidal thoughts in their minds, perhaps with tragic results.

The Medicines and Healthcare Products Regulatory Agency undertook trials which showed that teenagers and children who took Seroxat were significantly more likely to experience such thoughts.

Sara Carlin, an 18-year-old Canadian student with everything to live for, hanged herself in 2007 despite official warnings (and warnings from her mother) that the drug could lead to self-harm.

Quite why it should magically be safe for adults, I am not sure. Nor was the coroner in the 2003 inquest on Colin Whitfield, a retired headmaster, aged 56, who slit his wrists in his garden shed two weeks after starting to take Seroxat. The coroner recorded an open verdict and said the drug should be withdrawn until detailed national studies were made.

Mr Whitfield’s widow Kathryn said: ‘We have no doubt that it was the drug that caused him to do it.’

I would also remind readers of the recent statement by Dr Declan Gilsenan, Ireland’s former Assistant State Pathologist, who says he has seen ‘too many suicides’ after people had started taking antidepressants and is sure the evidence is ‘more than anecdotal’.

The defenders of this nasty, profiteering enterprise – including doctors who ought to know better – will come up with the usual bleat of ‘correlation is not causation’.

Just remember that this was the same sly song that Big Tobacco sang, when it first became obvious that cigarettes caused cancer. It is time for a proper investigation, with evidence on oath and the power of subpoena.

GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history

Don’t talk to me about ethics and trust. Don’t talk to me about company culture and values.

That’s one hell of a fine for Glaxo – the biggest healthcare fraud settlement in history… but in reality, it’s simply not enough – it goes nowhere near as far as it should.

There should be criminal prosecutions brought, because what we’re talking about here is not just illegal marketing of drugs – not just bribing doctors to prescribe GSK products – what we’re talking about here is dead people.

Patients have died because they were taking drugs that weren’t safe, drugs that weren’t even approved for their treatment.

In the case of Avandia, the drug is so dangerous that it can no longer be prescribed in Europe – it had to be withdrawn from the market because of high levels of heart attack, heart failure and stroke in patients.

It had to be withdrawn from the market because it killed too many people.

It makes you wonder how a drug like Avandia ever got a licence in the first place… how could the doctors running the drug trials have failed to see the dangers?

I think we should remember at this point it was GSK that paid for those very drug trials that painted Avandia in such a positive light. And Paxil. And Wellbutrin.

GSK has also admitted charges that it held back data and made unsupported safety claims over Avandia.

People have died. A fine is not enough.

Here’s the story from the BBC:

The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).

The settlement will cover criminal fines as well as civil settlements with the federal and state governments.
The case concerns the drugs Paxil, Wellbutrin and Avandia.

Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was “unprecedented in both size and scope”.

Doctors bribed
GSK, one of the world’s largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.

The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.

In addition, GSK has been found guilty of paying kickbacks to doctors.

“The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts,” said US attorney Carmin Ortiz.

As part of the settlement, GSK agreed to be monitored by government officials for five years.

GSK said in a statement it would pay the fines through existing cash resources.

Andrew Witty, the firm’s chief executive, said procedures for compliance, marketing and selling had been changed at GSK’s US unit.

“We have learnt from the mistakes that were made,” Mr Witty said. “When necessary, we have removed employees who have engaged in misconduct.”

SSRIs can give you digestive problems… and make you MORE depressed

Another hat-tip to the Truthman for this story from the Daily Mail.

As I’ve said before, the truth is slowly drip, drip, dripping out – one day I’m sure my children will be appalled that so many prescriptions were written for drugs like Seroxat that turned out to be so harmful to so many patients, much like the Thalidomide and Benzo scandals of the past.

What compounds matters for me is the role of the drug companies, like GlaxoSmithKline, that continued to aggressively market Seroxat, even when company insiders knew the drug was defective, dangerous and ineffective.

There was money  to be made and GSK wasn’t going let anything like negative trial results get in the way of profit. Especially not when Key Opinion Leaders could be relied on to say whatever a drug company told them to say – providing the KOLs were paid enough.

Anyway, I’ll get off my soapbox now and let you read the article from the Daily Mail:

Depression levels in Britain continue to spiral.

Last year alone, more than 43 million prescriptions for antidepressants were handed out — 25 per cent more than three years before.

But are antidepressants the panacea we hope them to be?

Drugs such as Prozac [and Seroxat] were hailed in the early Nineties as wonder pills that would banish depressive blues for good.

But in the past five years, growing scientific evidence has shown these drugs work for only a minority of people.

And now controversial research in a respected journal claims that these antidepressants can make many patients’ depression worse.

This alarming suggestion centres on the very chemical that is targeted by antidepressants — serotonin.

Drugs such as Prozac [and Seroxat] are known as selective serotonin reuptake inhibitors (or SSRIs).

Their aim is to boost the level of this ‘feel-good’ chemical in the brain.

But the new research, published in the journal Frontiers In Evolutionary Psychology, points out that serotonin is like a chemical Swiss Army knife, performing a very wide range of jobs in the brain and body.

And when we start deliberately altering serotonin levels, it may cause a wide range of unwanted effects.

These can include digestive problems, sexual difficulties and even strokes and premature deaths in older people, according to the study’s lead researcher Paul Andrews. 

‘We need to be much more cautious about the widespread use of these drugs,’ says Andrews, an assistant professor of evolutionary psychology at McMaster University in Ontario, Canada.

Previous research has suggested that the drugs provide little benefit for most people with mild and moderate depression, and actively help only a few of the most severely depressed.

Eminent psychologist Irving Kirsch has found that for many patients, SSRIs are no more effective than a placebo pill.

Two years ago, the Canadian Medical Association Journal reported a 68 per cent increase in risk of miscarriage in women on antidepressants.

Drugs such as Prozac [and Seroxat] are known as selective serotonin reuptake inhibitors (or SSRIs). Their aim is to boost the level of this ‘feel-good’ chemical in the brain

And research in 2009 on Danish children found a small, but significant, increase in the risk of heart defects among babies whose mothers had used SSRIs in early pregnancy.

There is also growing evidence that long-term use in adults is linked to bleeding in the gut and increased risk of stroke.

The key to understanding these side-effects is serotonin, says Andrews. Serotonin is also the reason why patients can often end up feeling still more depressed after they have finished a course of SSRI drugs.

He argues that SSRI antidepressants interfere with the brain, leaving the patient vulnerable to a ‘rebound’ depression of even greater intensity than before.

‘After prolonged use [when a patient stops taking SSRIs], the brain compensates by lowering its levels of serotonin production,’ he says, adding that it also changes the way receptors in the brain respond to serotonin, making the brain less sensitive to the chemical.

These changes are believed to be temporary, but studies indicate that the effects may linger for up to two years.

Relapsing is not exclusive to SSRI drugs — it is, in fact, seen in all the classes of antidepressant medications — but Andrews believes that the risk is particularly strong with SSRI drugs.

Moreover, he warns that antidepressants can disrupt all the physical processes that are normally regulated by serotonin, adding that animal studies show only about 5  per cent of the body’s serotonin resides in the brain. Most is housed in the gut.

It is used, among other things, to control digestion, form blood clots at wound sites, and regulate reproduction and growth.

So a drug that interferes with serotonin may cause developmental problems in infants, problems with sexual stimulation and sperm development in adults, digestive problems such as constipation, diarrhoea, indigestion and bloating, and abnormal bleeding and stroke in the elderly.

The drugs may also raise the risk of dementia.

Most disturbingly of all, Andrews’ review features three recent studies which, he says, show that elderly antidepressant users are more likely to die prematurely than non-users, even  after taking other important variables into account.

One study, published in the British Medical Journal last year, found patients given SSRIs were more than 4 per cent more likely to die in the next year than those not on the drugs.

‘Serotonin is an ancient chemical,’ says Andrews.

‘It is intimately regulating  many different processes, and when you interfere with these things, you can expect that it is going to cause some harm.’

Stafford Lightman, professor of medicine at the University of Bristol, and a leading UK expert in brain chemicals and hormones, says Andrews’ review highlights some important problems, yet it should also be taken with a pinch of salt.

‘This report is doing the opposite of what drug companies do,’ he says.

‘While drug companies selectively present all the positives in their research, this selectively presents all the negatives that can be found.

Both approaches are simplistic. And while SSRIs might possibly cause rebound depression, it is also sadly natural to expect that people with severe depression will see their illness come back, and often in a worse state.

‘Nevertheless, the study is useful in that it is always worth pointing out that there is a downside to any medicine.’

Professor Lightman adds that there is still a great deal we don’t know about SSRIs — not least what they actually do in our brains.

‘It’s a bit embarrassing, but the bottom line is that we don’t really know how they work,’ he says.

‘Basically, we started using these drugs before we understood what they do, because they showed some effectiveness.’

When it comes to understanding why the drugs work only for a limited proportion of patients, U.S. scientists think they might now have the answer.

They think that in many clinically depressed patients, it’s not only the lack of feel-good serotonin causing their depression, but also a failure in the area of the brain that produces new cells throughout our lives.

This area, the hippocampus, is also responsible for regulating mood and memory. Research suggests that in patients whose hippocampus has lost the ability to produce new cells, SSRIs do not bring any benefit.

But why the hippocampus should do this — and how it should be treated — is not clear.

And even if those answers were found, they might still not produce a cure for many cases of depression, because the condition varies so widely in its causes and is so little understood.

What should be sure is that the days of doctors habitually prescribing SSRIs to all and sundry on the basis that they might work, and won’t do any harm anyway, really should be behind us.

Can you really believe they said this – 2012 reprise

They say hindsight is 20/20 vision.

Well, here are a bunch of quotes I’ve posted over the years for you to consider with the gift of hindsight.

 

It’s not possible really to measure total serotonin. We do not know with absolute certainty about how any of the antidepressants work. 
Alan Metz 
Glaxo Vice President for Clinical Development
source: Generation RX

No, we are not misleading them [patients]. The information in the patient leaflet and in the information we supply to doctors, is based on fact. 
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline
10/13/02

….there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/19/2000

Physical and Psychologic Dependence: PAXIL has NOT been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic…
GSK Patient Information Leaflet

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

Drugs like Seroxat [Paxil] have been around for almost a decade and help millions of people fight depression. There’s no reliable scientific evidence to show they cause withdrawal symptoms or dependency. 
Alan Chandler 
GlaxoSmithKline spokesperson

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

The side effects [of Paxil “discontinuance”] are things like dizziness, nausea, headache, um, and are clearly labeled in the information made available to doctors and patients. 
Dr. Alastair Benbow 
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

I think patients have nothing to fear from taking Seroxat. 
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
6/13/2002

Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming. 
David Stout President
US Pharmaceuticals
GlaxoSmithKline
10/10/2002

It was quite clear from talking to patients and as a doctor that’s very, very important to me, it’s quite clear that the phrase “Seroxat is not addictive” was poorly understood by them. 
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline
5/11/03

I think you have to develop a culture where if there is bad news you don’t sit on bad news. Bad news does not get any better. It can only get better if it’s admitted, understood and addressed.
Robert (Bob) Ingram
Vice Chairman, GlaxoSmithKline Pharmaceuticals
8/25/2002

We’re reviewing every single process at the company. The environment of the business has changed after Enron. I believe that there was a lack of trust [on the part of] the public for big business, and that lack of trust has been amplified by a few bad apples in the cart. And because of that, there has been a tremendous loss of trust in all big business not just pharma and that has implications to me as a CEO.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
10/4/2004

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

We don’t want to be accused of anything about the way we deal with trials.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/21/2004

As a knowledge-based industry we understand full well the value of information, and we want to create a climate of openness where the evidence for prescribing our products is clear.
Richard Sykes
Chairman of Glaxo Wellcome
6/19/2004

I think if, if we’ve been guilty of anything over the past few years, perhaps, um, emphasizing entertainment over education, um, we know that’s what patients really want.
Christopher Viehbacher
GlaxoSmithKline U.S. President
8/16/05

Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
10/13/02

My wife thinks J.P. [Garnier] is the best thing since sliced bread. 
Christopher Viehbacher
GlaxoSmithKline U.S. President
7/21/03

We are a high-integrity company. We know what the rules are and we follow them.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/6/2004

The vast majority of drugs more than 90 per cent only work in 30 or 50 per cent of the people, I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody. 
Dr. Allen Roses 
GlaxoSmithKline Senior V.P.
Genetics Research
12/8/2003

If anyone thought drugs were without side-effects, hopefully that’s over. All drugs have side-effects. We are having to spend hundreds of millions of dollars on lawyers.
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline
4/23/2005

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

This is a company that is reinventing itself … possibly creating a model for pharma companies. 
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline
7/21/03

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm. 
Dr. Alastair Benbow 

GlaxoSmithKline’s European Medical Director
10/3/2004

So we always want to make sure we are serving the good, the right purpose…. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
9/9/2004

I’ll be a hero in three years. 
Jean-Pierre Garnier 
Chief Executive Officer GlaxoSmithKline
4/5/2004

I am sure it happens because academics are very, very busy people, and they prefer to do research than spend a lot of time writing papers. If the industry puts forward a method of relieving them of that chore, then I am sure that that does happen throughout the industry. That would be true generally. Is it a good idea? I think it can be, as long as everybody is in agreement with what is written at the end of the day, the results and what they are. 
Sir Richard Sykes 
former Chairman of GlaxoSmithKline
On the industry practice of “ghostwriting medical reports” and “gift authorship.” 12/7/2004


We have acted responsibly in conducting clinical studies in pediatric patients and the dissemination of the results. We would strongly disagree with any allegation that we have done otherwise. 

Dr. Tadataka Yamada 
Chairman of Research and Development
GlaxoSmithKline
6/19/2004

You can experience symptoms, as you can with other SSRIs and as you can with other kinds of medicines as well. 
Mary Anne Rhyne
GlaxoSmithKline spokesperson
12/13/2003

What we have seen in terms of the anecdotal reports [of Paxil withdrawal] is that it happens very rarely. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
8/25/2000

While GlaxoSmithKline strives to produce medications that safely and effectively treat medical conditions, we’re also committed to protecting the environment. 
Dr. Anne Phillips 
Chief Medical Officer of GlaxoSmithKline
source: GlaxoSmithKline

As you can see here, few numbers of patients experienced any adverse event after being randomized off [Paxil] into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population in our attempt to systematically assess a discontinuation syndrome. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services Excerpt from a transcript of the FDA Review of Paxil
10/5/1992

I have my iPod and my Bose headphones. You can run anywhere. I’m in a bubble. When I go home I don’t talk about my job. It drives my wife crazy because when we go out she doesn’t know anybody. Socially we see politicians we have to and she knows nothing about the issues. But that’s the way I like it. I want to go home and say, ‘hey what happened to you?’ I have a very demanding job and I don’t want to go home and discuss the same stories. 
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline
4/23/2005

We feel strongly that we have an obligation to speak up both for the millions of patients that Seroxat allows to lead a normal life, and for our employees whose commitment to this important medicine has made such a positive difference to so many people. 
Eddie Gray 
General Manager
GlaxoSmithKline UK
10/10/2002

My mum, you know, she thinks her son walks on water….. 
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
4/23/2005

….recognize that in the final analysis success rests on selecting the right people to work with. If you have the right people, the rest will follow. 
Jan Leschly 
Former CEO of SmithKline Beecham

It’s becoming too easy for many people to attack the pharma industry and hold the pharma industry to standards that are higher than anywhere else. I don’t have a problem with the standards….

Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline
6/6/2004

Of course we didn’t follow this advice. Of course we didn’t selectively publicize the data. This is not a smoking gun. It’s a stupid memo and there are lots of stupid memos in every company’s file and it is really unfair to look at the company’s action through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist but I’m not going to lose sleep over the fact.
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline
6/6/2004

I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing.
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline
6/15/2003

Corporate responsibility is not just a job for selected people at GSK, it defines the way we do business. Our ten corporate responsibility principles set thestandard for everyone, since responsible business is only a reality if it is practised by all employees at all times. 
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago. 
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline 10/10/2002

Human behavior is we know so little about it, and therefore, to try to speculate on a mechanism for human behavior is very difficult. 
Dr. Tadataka Yamada 
Chairman of Research and Development GlaxoSmithKline 1/24/2001

Sometimes a system indeed hinders your rise up the ladder but you also have to accept personal responsibility. That translates into realizing that it’s not always someone else’s fault that you didn’t get promoted. You have to ask some serious questions of yourself before you point the finger at someone else. Ask yourself, `What have I done?’ ‘What is my role in this?’ ‘What am I willing to do?’ 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/26-27/1995

If we meet the test of our highest purpose nothing less than making historic contributions to human welfare then we will surely meet our important responsibilities to other GlaxoSmithKline stakeholders, to the investors who put their trust in our performance, to the communities in which we operate, to our colleagues and to ourselves. 
Dr. Tadataka Yamada 
Chairman of Research and Development
GlaxoSmithKline from GSK’s web site

We are all in favour of this being scrutinized all the time, because it is not in our interests to have a product on the market that is not safe or effective. 
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline 2/15/2002

I think fundamentally the public needs to be reassured that multinational companies and globalisation are not bad quite the reverse. 
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
2/18/2003

We take the safety of our medicines extremely seriously…. 
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
1/31/2001

Great [GSK] products, however, are not the whole story society expects companies to act responsibly in their pursuit of success. If anything, the fact that our business is about human health makes it even more important that we operate to the highest standards.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

I think to focus on safety is important.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
3/01/05

….my experience is that most physicians don’t look at the [a drug safety] label very carefully. And I’m not certain. I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section….
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
1/24/2001

Responsible business practices are also the key to a good reputation. In 2004, the pharmaceutical industry and GSK continued to come under public scrutiny on how medicines are developed, tested and marketed. To meet this challenge we must act with integrity and be open about our approach to these important issues.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

Our concern is people’s safety.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
3/1/2003

Anybody who suffers side effects of any sort I feel every sympathy for….
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
5/11/03

Everybody who has looked at this the FDA, American Psychiatric Association, National Mental Health Association all those groups agree that SSRIs, like Paxil, are not addicting and not habit forming.
Andrew T. Bayman
attorney for GlaxoSmithKline
King & Spalding

GSK strongly stands behind the safety and efficacy of Paxil. Physician organizations, like the American Psychiatric Association, have stated that antidepressants are not habit-forming.
David Stout
President of U.S. Pharmaceuticals, GlaxoSmithKline

GlaxoSmithKline is proud to offer physicians Paxil CR the latest treatment advance in the SSRI class.
David Stout
President, US Pharmaceuticals, GlaxoSmithKline
4/19/2002

We missed something big we missed the fact that the public wasn’t going to necessarily trust us.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
8/13/2005

 

Glaxo – a simple challenge for you…

It’s been a while since I wrote anything as I’ve been very busy with my day job.

Happily, others have continued to write – I’ve just read a post over at Seroxat Suffers about Glaxo in New Zealand and the Patient Information Leaflet that comes with Aropax (Seroxat).

According to Glaxo (only in New Zealand, though):

Depression is longer lasting or more severe than the low moods that everyone has from time to time. It is thought to be caused by a chemical imbalance in parts of the brain.

AROPAX corrects the chemical imbalance and so helps relieve the symptoms of depression.

Sorry, but I have to throw the gauntlet down to Glaxo on this one… I think in 2012 it’s fair to say that the chemical imbalance story has been discredited completely.

But, Glaxo, if you can tell me what the correct level of Serotonin is in a human brain, then I’ll listen.

If you can measure how much Serotonin I currently have in my brain, then I’ll listen.

If you can then demonstrate how much 20mgs of Seroxat will raise my brain serotonin level by, then I’ll listen.

But the problem is that Glaxo can’t do any of those – the idea of a ‘chemical imbalance’ causing depression – and even the term ‘SSRI’ – was invented by marketing and PR companies, simply to sell a drug.

To use a technical term, it’s complete bollocks.

 

 

If you don’t want to believe me…

I think we all know the internet is overflowing with all kinds of dubious sources of ‘information’ sources.

I’m a patient who suffered greatly at the hands of GlaxoSmithkline and decided to tell my story by creating this blog. As such I freely admit that I am not, by any stretch of the imagination, unbiased.

I see what I do as trying to counter (in some small way) the spin and lies that Glaxo routinely produces every week of the year.

I also hope I may be able to help some people understand what’s happening to them if they are suffering from Seroxat addiction and are trying to withdraw from the drug.

But if you don’t want to believe me, then can I suggest you look at the new blog written by Dr David Healy – Dr Healy being the internationally respected psychiatrist, pyschopharmacologist, scientist and author. I can’t recommend this blog enough. Go there now!

And for the record:

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of Seroxat.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Maybe you should believe me – I do know what I’m talking about.

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