What I believe

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 Seroxat is addictive.

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

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 doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

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.

Believe me – I know what I’m talking about.

RxISK – Making medicines safer for all of us

This is good.

Here’s a new website that Prof David Healy’s involved with. RxISK is a free, independent drug safety website where you can research a prescription drug to see what side effects have been reported and also share your experience and get a free RxISK Report to take to your doctor if need be.

This from RxISK:

A Good Drug is a chemical + Good Information. Most of the information on what drugs actually do is missing. Only you can provide it. Using RxISK will tell you more about the drugs you are prescribed than anything else will. By reporting to RxISK you can help make Good Drugs. Less than 5% of drug side effects are reported. Your voice has been silenced – globally.

Little is known about the effects of drugs on our hair, sex and relationships, violent and other extreme acts or thoughts, and our skin and nails, because these effects are not considered medically significant and are not tracked.

We have created the RxISK Zones with two purposes in mind:

  1. To enable you to easily search for prescription drug side effects on hair, sex, violence, suicide, and other aspects of our every day lives in the more than three million adverse drug event reports filed with the FDA since 2004, as well as our expanding RxISK database.
  2. To make it even easier for you to report these types of prescription drug side effects on RxISK.org and with your country’s drug regulator or the FDA if we don’t yet have your country’s form.

Just imagine — by reporting your experiences, you can help make RxISK the most comprehensive source of independent information on drug side effects in these important personal areas.

How it works

At the bottom of any Zone page, simply enter a prescription drug and click Continue. On the following summary page, check the box next to any side effect you are experiencing, and click the Report a drug side effect button to quickly create your personalized RxISK Report with your RxISK Score to take to your health care professional to help them help you.

The page is here if you want to add to the real world knowledge available about the drugs you take.

Seroxat litigation in the UK – important news

The High Court action against Glaxo isn’t quite over.

There were 500 litigants to start with. This number dropped to about 150.

These 150 people received a letter recently.

And today, I have been sent a copy of this email:

Hi All, If you haven’t already, please can you get in touch with Sarah-Jane Richards at Secure Law to confirm you want to continue in the action and you are happy for her to represent you.  You need to do this and previous correspondence will not count as this involves the instruction of a new law firm…we really need strength in numbers.  Please can you also confirm if you are happy for your email to be added to her list and advise if you are still taking Seroxat and if you are on benefits.

If you’ve got the letter, you’ve got the link.

Use it.

Should we trust GlaxoSmithKline – and Andrew Witty…?

Trust GlaxoSmithKline?

Trust GSK? – you must be mad.

Sarah Boseley in The Guardian writes:

“The British drugs company GlaxoSmithKline is to open up the detailed data from its clinical trials to the scrutiny of scientists in a bid to help the discovery of new medicines and end the suspicions of critics that it has secrets to hide.

In a speech today [11 Oct] to the Wellcome Trust in London, the chief executive, Andrew Witty, will say openness to the public and active collaboration with scientists and firms outside GSK are essential to finding new drugs to treat the diseases plaguing the world, from novel antibiotics to cures for malaria and tuberculosis.

He told the Guardian GSK had already done much to advance transparency in clinical research, including publishing a summary of every drug trial – whether a success or not – on its website

Said Sir Mark Walport, director of the Wellcome Trust – “In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today.”

But hold on a minute – Dr Ben Goldacre’s not sure about GSK :

“But we should judge drug companies by their actions, not by their promises, especially when similar promises have been made in the past, and then broken.

In 1998 GlaxoWellcome promised to set up a clinical trials register, amidst outcry over withheld trial results. But when the company merged with SKB to create GSK, in 2002, this register was unceremonially deleted from the internet. This tragic story is described in an excellent open access article on this history of attempts to get access to hidden data, by Iain Chalmers.

Then, in 2003, GSK were caught withholding clinical trial data showing that their drug seroxat increases the risk of suicide in young people. As part of the settlement on fraud charges, in the US in 2004, GSK were forced to promise to post all trial results on a public website. But in 2012 GSK paid a new $3bn fine for criminal and civil fraud: this included charges over withholding data on the diabetes drug Avandia, as late as 2007, well after this earlier promise of transparency was made”.

That’s a pretty poor record, I’m sure you’ll agree.

As far as GSK is concerned, talk is cheap and promises are routinely broken with no compunction whatsoever.


Inside Paxil Study 329, Courtesy the Justice Department

This is from Dr Howard Brody’s blog – Hooked: Ethics, Medicine, and Pharma

It sums up the story of Study 329 (with links to the original DoJ documents) and dovetails with the current scandal over Glaxo’s record $3 billion fine for witholding negative drug trial data for Avandia, the illegal marketing of drugs and bribing doctors to prescribe Glaxo products.

Remember, Study 329 was not covered by the latest $3 billion fine – Study 329 was yet another example of Glaxo’s lying and cheating to sell its drugs.

Now read on:

I’ve previously discussed the now-infamous Study 329, which took discouraging data on the efficacy and safety of paroxetine (Paxil) in kids and spun it into an article claiming excellent results:

Thanks to the U.S. Justice Dept. complaint in the suit recently settled by GlaxoSmithKline for a record $3B: http://www.justice.gov/opa/documents/gsk/us-complaint.pdf
–we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes.

Study 329, directed by Dr. Martin Keller of Brown University, was one of 3 clinical studies in children and adolescents that were all interpreted by GSK scientists between August and October, 1998 to be discouraging. Study 329’s protocol specified two primary endpoints, and on neither measure did Paxil do better than placebo. The study also logged in 11 serious adverse reactions to Paxil, much more than in the placebo group, including 5 with agitated or suicidal behavior, the major risk for which eventually the FDA issued a black-box warning for the SSRI class of antidepressants.

Undaunted, GSK contracted in April 1998 with Scientific Therapeutics Information, Inc. to prepare an article for journal publication based on 329. As we know from other sources, STI writers basically wrote the paper and later did revisions, with minimal input from the supposed scientific authors, meaning that the paper was largely if not completely ghostwritten. As part of the laundering process, STI decided to downplay the primary endpoints and instead inserted 8 “efficacy measures,” none of which had been specified in the original study protocol. By what’s called data-dredging, STI was able to show that Paxil was statistically better than placebo on 4 of the 8 newly invented measures.

Initially the purported authors sent the paper to JAMA, claiming in the abstract that Paxil was “a safe and effective treatment for major depression in adolescents.” In December, 1999 JAMA rejected the paper, and reviewers’ comments indicated that the scientific reviewers had seen through the fog and realized that there were no solid data to show the superiority of Paxil. One internal memo then indicated that GSK and Dr. Keller agreed to send the manuscript to “a less demanding journal.”

Even the less-demanding Journal of the American Academy of Child and Adolescent Psychiatry originally couldn’t swallow the revised manuscript that Keller and company sent them in June 2000. Their reviewers detected some of the same problems as the earlier JAMA review.  GSK had STI go back to work responding to the reviewers’ comments and eventually JAACAP accepted the manuscript in February 2001.

According again to the Federal complaint, even with the recommended changes, GSK and STI (with the willing acquiescence of Dr. Keller and his co-authors, we presume) managed to slip in a number of incorrect and misleading statements. The abstract stated that the drug “is generally well tolerated and effective for major depression in adolescents.” The article mentioned the primary endpoints but failed to make clear that by neither was Paxil statistically superior to placebo. The article falsely implied that Paxil was superior on one of the primary endpoints by deliberately conflating one of the later “efficacy measures” with that endpoint. The article consistently downplayed all the measures where Paxil failed to show superiority to placebo and focused on the few, invented-later measures where a statistically significant result had been found.

More important, the 11 patients with serious adverse reactions due to Paxil, and the 5 of them with specifically suicidal or agitated symptoms, magically disappeared. In the revised manuscript the investigators suddenly decided that only one of the reactions (headache) was actually caused by Paxil, and the other bad outcomes were unrelated to the drug. When the FDA got its hands on the raw data from 329, it eventually determined that 10 of 93 patients taking Paxil had experienced a potentially suicidal reaction–a far different and scarier picture than that portrayed in any of the drafts or in the final manuscript.

To be sure that child psychiatrists heard the correct marketing message, GSK sponsored 8 “Forum” meetings at lavish resorts such as Rio Mar Beach Resort in Hawaii and Renaissance Esmerelda Resort in Palm Springs, CA. The psychiatrists who attended had their airfare and hotel paid plus a $750 honorarium, and in many cases their spouses were also paid for (a practice supposedly prohibited in the 2002 PhRMA code of conduct). The hired speakers who told them how wonderful Paxil was for treating kids received $2500 honoraria in addition.

Talking of speakers’ bureaus, another media summary of the complaint:
–reported that GSK had enrolled 49,000 health professionals to be on its speakers’ bureau for Paxil and other drugs. Two conclusions are possible: 1) there are 49,000 really excellent and scientifically informed speakers out there whose talents are needed to inform their fellow practitioners; or 2) a “speaker’s bureau” is really nothing but a disguised bribe to get all those docs to prescribe a lot of the drugs they are paid to speak about.

Hat tip to Dr. Roy Poses of Health Care Renewal blog for sending me the link to the full complaint (all 76 pages, for anyone who wants some fun reading).

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.

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

….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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

We follow the law, and we follow government guidelines. 
Mary Anne Rhyne 
GlaxoSmithKline spokesperson

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

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

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

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

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

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

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

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

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

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

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

….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

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

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

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

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

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

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

….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

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

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

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

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


Family double death horror

I’ve just seen this terrible story in the Daily Mirror:

A father is believed to have returned home yesterday evening to find his two young children murdered and his wife with her wrists slit.

Emergency services were called to the home in Wandsworth, south west London, but the 10-week-old baby boy and one-year-old girl were pronounced dead at the scene.

A post mortem is due to take place today although reports have suggested the children showed no signs of injury and may have been smothered.

A woman in her mid-30s, believed to be the man’s wife, was arrested over the deaths and is being questioned by detectives today.

She is understood to have self-harmed but did not require hospital treatment.

Police are believed to be investigating the possibility that the mother was suffering from post-natal depression.

In cases like this, I believe one of the first things to establish is what (if anything) the woman was being treated with for her depression…

The authorities simply must start to take notice about this issue and the public deserves to know if there is a connection between acts of extreme violence and drug treatment – I believe that antidepressants can cause extreme violence.

All too often in the past, it seemed that the only other people in the world who would ever begin to entertain the possibility were people such as Michael Moore and Dr Peter Breggin in the USA – and in England David Healy, Andrew Herxheimer and David B. Menkes, who co-authored a paper on the subject in 2006 – Antidepressants and Violence: Problems at the Interface of Medicine and Law.

If you want more information, then you can read follow up with these links (or just type ‘Violence’ in the search box on the left of your screen:

What made Raoul Moat do it

Nebraska shooting – antidepressant connection yet again?

Lost in translation – were Anti-Depressants Involved In Finland School Massacre?

A brief history of school shootings

The Finland Massacre

SSRI stories

Antidepressants and violence

As I’ve said, there has to be a proper investigation into this issue – and I believe that the drug companies (such as Glaxo) know the problem exists, but have done nothing about it as it would have affected their profits.



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