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:
http://brodyhooked.blogspot.com/2011/11/will-brown-university-investigate.html

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:
http://finance.yahoo.com/news/glaxosmithklines-gsk-3-billion-whistleblower-154800879.html
–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.

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