Category: GSK Fraudulent Data

Vaccine victims are now slowly rising up against Big Pharma


http://www.newstarget.com/2016-03-29-vaccine-victims-are-now-slowly-rising-up-against-big-pharma.html

Vaccine victims are now slowly rising up against Big Pharma

Image: Vaccine victims are now slowly rising up against Big Pharma

The 2009 swine flu panic has prompted more than 60 million people to get vaccinated against the disease. Unfortunately, thanks to the damaging effects of the vaccine, countless numbers of individuals have now developed a range of health problems, including sleep disturbances, memory impairments and even brain damage!

Pharma corporations, of course, are always quick to deny allegations against the damaging effects of vaccines. Last year, however, Big Pharma’s protective cloak seemed to have slipped quite a bit, as pharmaceutical giant GlaxoSmithKline (GSK), the manufacturer of the swine flu vaccine Pandemrix, was ordered to pay about $60 million in damages to the UK government after it was determined that Pandemrix played a significant role in causing brain damage to several individuals.

“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries — and probably in most countries,” says Emmanuelle Mignot, a sleep disorder specialist from Stanford University.

Despite numerous evidence linking health problems to Pandemrix, GSK continued to turn a blind eye on the allegations against it. Even when, in 2011, the European Medicines Agency issued a warning stating that people under 20 should refrain from getting the vaccine, GSK remained mum.

Thankfully, all hope’s not lost for those who have long suffered from Big Pharma’s neglect. After last year’s ruling against GSK, more and more vaccine victims have now been getting their rightful reparations.

Take the case of ten-year-old Josh Hadfield from Somerset, England. After being given Pandemrix in 2010, Josh developed narcolepsy, a rare neurological condition causing excessive drowsiness, and cataplexy, a condition causing abrupt temporary loss of muscle function. After years of hurdling through the initially uncooperative stance of the UK government, just this year, Josh was awarded £120,000 in damages for his ordeal.

While, of course, monetary compensation would not be enough to totally indemnify numerous families for their vaccine-caused suffering, the recent ruling against GlaxoSmithKline definitely is a positive step towards eventually beating the Big Pharma vaccine monopoly.

Sources used:

NaturalNews.com

BBC.com

TruthWiki.org

Science.NaturalNews.com

Who Will Replace His Royal-Ness Andrew Witty At GSK?


It seems to be that GSK just replace one sociopath with another..

I can just imagine the interview process for CEO…

We’ve had JP Garnier (he was a very good sociopath), then we had Witty (who was arguably even better).. very convincing , very slick…

Who next?

I bet it’s something like a tick the boxes ‘sociopath’ checklist for the selected candidates…

Something like this perhaps?…


2960020302001

 

 

 


http://news.sky.com/story/1661575/woodford-demands-outsider-to-take-gsk-helm

Woodford Demands Outsider To Take GSK Helm

The high-profile fund manager tells Sky News a “fresh pair of eyes” is needed to replace Sir Andrew Witty at GSK.

10:58, UK, Thursday 17 March 2016

GlaxoSmithKline Chief Executive Andrew Witty poses with his medal after being honoured with a Knighthood by Prince Charles

Sir Andrew Witty poses after being honoured with a knighthood

Britain’s biggest drugs-maker, GlaxoSmithKline (GSK), has been told to ignore internal candidates in its search for a new boss as shareholders intensify demands for a radical overhaul of the company.

Speaking exclusively to Sky News, Neil Woodford, the City’ s best-known fund manager, said that GSK needed “a fresh pair of eyes” to replace Sir Andrew Witty, who will step down next year.

“I have a strong preference for an external candidate,” the head of investments at Woodford Investment Management said on Thursday.

Mr Woodford’s demands will put pressure on Sir Philip Hampton, GSK’s new chairman, to appoint an executive from elsewhere in the pharmaceuticals industry to succeed Sir Andrew.

That would come as a blow to possible internal candidates such as Emma Walmsley, who runs GSK’s consumer products division, and Abbas Hussain, president of its global pharmaceuticals unit.

Sky News revealed last autumn that Mr Woodford was seeking a break-up of the £69bn company, which owns brands such as Nicorette and Horlicks.

He believes the group would be far more valuable if it separated its HIV business ViiV, its consumer healthcare division and Stiefel, its dermatology division, from its core medicines and vaccines arm.

GSK said on Thursday that Sir Andrew would step down at the end of March 2017, with a formal recruitment process now underway.

The City has grown frustrated at GSK’s lacklustre share price performance, with the stock down about 10% over the last 12 months as investors wait to see whether a pipeline of promising new products will deliver.

Under Sir Andrew, its chief executive since 2008, GSK has signalled a shift away from highly priced prescription drugs in favour of vaccines and consumer products.

Analysts at Deutsche Bank said the announcement about Sir Andrew’s retirement was unlikely to signal material strategic changes at GSK.



http://www.bloomberg.com/news/articles/2016-03-17/glaxo-chief-executive-witty-plans-to-step-down-next-year

GlaxoSmithKline CEO Andrew Witty to Retire in March 2017
Marthe Fourcade
Ketaki Gokhale
KetakiGokhale
March 17, 2016 — 7:12 AM GMT
Updated on March 17, 2016 — 12:10 PM GMT

Board will search for CEO candidate inside, outside drugmaker
Chairman Hampton also plans `board refreshment’ this year

GlaxoSmithKline Plc Chairman Phil Hampton began an overhaul of the biggest U.K. drugmaker by launching a search for Chief Executive Officer Andrew Witty’s successor and replacing a third of the board as he seeks to pacify some disgruntled investors.

Witty, 51, will retire next March, after almost a decade at the helm, the London-based company said in a statement on Thursday. Glaxo also plans what Hampton termed a “board refreshment” as directors Deryck Maughan, Stephanie Burns, Daniel Podolsky and Hans Wijers won’t stand for re-election at the annual meeting in May.

Andrew Witty
Andrew Witty
Photographer: Simon Dawson/Bloomberg

Witty, once hailed as one of the pharmaceutical industry’s most visionary managers, has faced criticism for Glaxo’s lagging share performance, sluggish sales and a pipeline lacking promising medicines. A bribery scandal in China that led to a $489 million fine last year also tarnished his image, which he had built with initiatives to develop the world’s first malaria vaccine and reform the way medicines are marketed to doctors.

“Glaxo needs a shakeup at the top,” said Gareth Powell, a portfolio manager at Polar Capital LLP in London whose holdings include Glaxo shares. “There’s a lack of truly innovative products, and that’s what they need to sort out.”
Right Time

Last year, Witty oversaw the biggest reorganization since the merger that created Glaxo 15 years ago. He sold the company’s cancer drugs to Novartis AG in exchange for the Swiss firm’s vaccines business and cash. The companies also formed a joint venture, controlled by Glaxo, to sell consumer health products.

Glaxo shares fell 1.3 percent to 1,394 pence at 12:07 p.m. in London trading. The stock has returned an average of 10 percent a year over the past five years, compared with a 17 percent average annual return for the Bloomberg Europe Pharmaceutical Index.

“By next year, I will have been CEO for nearly ten years and I believe this will be the right time for a new leader to take over,” Witty said in the statement. He began leading Britain’s largest drugmaker in 2008 after more than 20 years at the company, including postings in the U.S., Asia and Africa.
Avoiding Deals

Both internal and external candidates will be considered for the role. Glaxo investor Neil Woodford said he would like to see someone from outside the company take the top job. One of that person’s first tasks may be to slash the dividend, investors said.

Potential candidates include Emma Walmsley, head of Glaxo’s consumer-health division, and Abbas Hussain, president of its drug business, according to reports in U.K. media. Chief Financial Officer Simon Dingemans and Roger Connor, who oversees global manufacturing and supplies, may also be considered as internal successors. David Epstein, head of Novartis’s pharmaceutical unit, may also be approached, the reports said.

Witty’s views have diverged from those of his peers. He has avoided large-scale acquisitions that have consumed others such as Pfizer Inc. and Teva Pharmaceutical Industries Ltd. And in 2011, he started a program called Patient First that eliminated the link between sales targets and bonuses for Glaxo’s U.S. marketing team, following allegations of illegally promoting drugs. Few drugmakers followed his lead.
Fresh Board

Glaxo’s sales declined to 23.9 billion pounds ($34.2 billion) last year from a peak of 28.4 billion pounds the year after Witty joined. Core earnings per share will probably surge this year, the company has said, after two years of declines.

“The decision will allow him to step aside at a high point following the company’s expected return to double-digit earnings growth in 2016,” Richard Parkes, an analyst at Deutsche Bank AG in London, wrote in a note to clients.

One bright spot has been Glaxo’s portfolio of HIV medicines, which the company considered spinning off in an IPO before opting to keep it. The British drugmaker also has one of the broadest drug pipelines in the industry, with more than 70 new medicines in development (though many are early-stage drugs that won’t deliver sales anytime soon), according to a Bloomberg Intelligence pipeline analysis.

A breakup of the company, favored by some investors including Woodford, might not generate that much value, according to an analysis by Bloomberg Intelligence analyst Sam Fazeli. Separating the drugs, vaccines and consumer-health units will probably increase Glaxo’s enterprise value of 83 billion pounds ($118 billion) by 10 percent or less, he estimated.

SSRI Anti-Depressants : Harmful Or Helpful?


“It is absolutely horrendous that they have such disregard for human lives.”
Professor Peter Gotzsche, Nordic Cochrane Centre

I’m blogging over 9 years (I started this blog in 2007), and in that time I have read tons of stuff about SSRI anti-depressants, psychiatry, and the pharmaceutical industry. I have focused my attention, in particular, upon the SSRI anti-depressant drug Seroxat, and the pharmaceutical company that manufactured it- GlaxoSmithKline (GSK). However, even before I started this blog, I had been educating myself about SSRI’s, the pharmaceutical industry, and ‘mental illness’ related issues. All in all, I have been reading, writing and researching about this stuff since at least 2001 (15 years). I had a particularly bad reaction to Seroxat, and I have no love for the pharmaceutical company who created it (GSK). I think GSK should have warned me about the dangers of Seroxat, and I believe that by suppressing information on Seroxat over the years, much harm was caused to me and to many many others.

The story of Seroxat is still as scandalous as ever.

I am particularly disturbed at how GSK behave generally too. They are an extremely sociopathic company, and they have absolutely no regard for patient well being, the law, or basic human values or ethics. They have been proven numerous times to be corrupt, devious and downright evil in how they behave. They have been fined numerous times for breaking ethical and legal codes in varous countries, however in their home turf of the UK it seems (because of the vast wealth that they bring there and the huge influence they have upon academia/industry etc) they are never brought to book. There are over 1000 blog posts on this blog detailing how GSK have corrupted doctors, the regulators and psychiatry, and I think my blog backs up my opinion on these subjects- ten fold. I had hoped, that by documenting GSK and Seroxat, others might not end up damaged by a pharmaceutical drug like Seroxat, I did it to bring awareness, it was that simple. I didn’t expect this blog to become the force that it has, I didn’t plan on being a blogger. I experienced an injustice from being prescribed the dangerous drug- Seroxat. I should have been warned, and I wasn’t. I met others who suffered because of Seroxat, and I felt compelled to do something about it- this blog spawned as a result of that impetus.

I have had some people e-mail me and thank me for saving their life, others have sent words of support and encouragement, or mentioned how my writing validated their experience, and I have received a lot of kindness because of my writing, and all of this has been extremely humbling for me, but none of this was planned.

(I have also had some psychos/stalkers/assholes and others who have pestered me from time to time- but those idiots will never stop me from helping others and bringing awareness).

Nevertheless, in all that time, and after digesting so much information about all this stuff, one of the most striking aspects of all this which I noticed is – just how polarized the debate about SSRI anti-depressants has been- over these years. There are those who swear blind that SSRI drugs are really helpful, and that the ‘risks’ are worth the (so called) ‘benefits’. There are people (usually biological psychiatrists) who claim that anti-depressants save lives, and they claim that SSRI anti-depressants are vital in the treatment of depression. Then there is an opposing camp who claim that these drugs are causing suicides, and that there risks far out weigh the benefits. I fall (like most reasonable people) somewhere in the middle…

I believe, or actually, in fact- I know (from my own experience, of almost 4 years on the SSRI Seroxat) that these drugs can be extremely harmful for a lot of people. I do understand that they can be somewhat helpful to others (perhaps very short term with close monitoring in extreme cases, or in a hospital setting), but I believe that the harms far out weigh the ‘benefits’. I also think that the so called ‘benefits’ are largely illusory, and often quite transient and subjective (if they exist at all). The benefit is an illusion just as much as the effect of any mind altering drug/substance is an illusion. Nevertheless, the only people who really know if these drugs are harmful or helpful are the people who take them. I don’t think that these drugs are helpful long term, nor do I think they should be prescribed as first line treatment.

These are potent, heavy, seriously addicting psychotropic/psychoactive/mind altering drugs; they are powerful and their affect on the mind is extremely difficult to predict in each individual. Some people will experience increased anxiety, increased suicidal ideation, hallucinations, distortions in their reality/perceptions/personality etc, and others might not experience these effects too badly. Most will experience some, or variations of these effects over time, and the longer you’re on them the more toxic you become. Withdrawal from them is often horrific too. However, most people will experience the physical side effects of nightmares, sweating profusely, stomach problems, irritability, tension, sexual side effects, nervous system side effects etc. The physical side effects in themselves can be extremely debilitating and disturbing. These drugs are quite toxic physically and they have been way too over-prescribed to too many people, mostly without adequate monitoring or informed consent.

It seems to me that those who defend the drugs without question are usually biological psychiatrists with a vested interest (either directly through pharmaceutical affiliation or indirectly through other means of the psychiatric profession) in keeping knowledge of the harms of these drugs as suppressed as possible.

The problem facing biological psychiatrists who defend the use of SSRI’s -almost evangelically – is- the cat is now fully out of the bag. You can’t defend these drugs in an extreme quasi-religious manner anymore without coming across as some kind of irrational zealot nutcase, because even the most eminent drug experts (the Cochrane group for example) now agree that there are serious issues with these drugs and in fact these drugs are very likely causing more harm than good. It has taken a few decades for the truth to finally become known, but the widespread consensus seems to be leaning towards the fact that these drugs are causing serious harm to a considerable number of people, and they have been for a very long time.

There will always be some biological psychiatrists who (seemingly desperate to hang on to some semblance of power and prestige in their own insecure minds) will defend these drugs like they are some kind of sacred religious iconography. They deem any criticism of the drugs as close to some kind of blasphemy. They imagine that if the drugs they dish out are undermined in any way, they themselves will be undermined also, and their beliefs and ideology will be debased as a result.  With their ego, their profession and their world view under threat of extinction from the truth, some of these psychiatrists can get very irrational and volatile indeed. Their egos just cannot take this perceived assault so they continue to deny despite the evidence rendering their denials redundant and ridiculous, because denial is all they have left as a defense.

Unfortunately, the ship of reason has sailed, and those psychiatrists are not on it.

These hell-fire and brimstone biological psychiatrists are few and far between nowadays, as most ‘clever’ psychiatrists are slowly starting to change their own discourse about SSRI’s so as to make it appear that they were never fully behind the widespread use of them in the first place (most of them really were, but at least some of them have the appearance of decency-or ‘devious intelligence’- to accept the truth and follow the tide of consensus).

It must be very difficult for some psychiatrists to accept that the drugs which they have been peddling for a very long time have perhaps harmed (and in some cases killed) many of their patients. It understandable what a hard pill of truth this might be to swallow (pardon the pun) for some of these individuals but the truth is self evident now. However continuing to deny the realities of the side effects of these drugs, and the harms that they caused, and continue to cause- is not acceptable.

Defending the drugs as a means of protecting the psychiatric ideological paradigm -at the expense of patients’ lives and public health- is utterly reprehensible- in my opinion.

There have been a flurry of articles, in the media recently, about the side effects of SSRI’s and much debate has ensued. However, instead of writing my opinion on each, I think it might be best to combine them all in one post.

The latest damning article about SSRI’s and their dangers comes from the Telegraph UK. The Telegraph article is based on a study from the Nordic Cochrane group. The Cochrane group are among the most respected (and widely cited) academics in the field of medicine.

Here are some excerpts from the article:

http://www.telegraph.co.uk/news/health/news/12126146/Antidepressants-can-raise-the-risk-of-suicide-biggest-ever-review-finds.html#disqus_thread

“…Antidepressants can raise the risk of suicide, biggest ever review finds

Antidepressant use doubles the risk of suicide in under 18s and the risks to adults may have been seriously underestimated, researchers found

Antidepressants can raise the risk of suicide, the biggest ever review has found, as pharmaceutical companies were accused of failing to report side-effects and even deaths linked to the drugs.

 

An analysis of 70 trials of the most common antidepressants – involving more than 18,000 people – found they doubled the risk of suicide and aggressive behaviour in under 18s.

 

Although a similarly stark link was not seen in adults, the authors said misreporting of trial data could have led to a ‘serious under-estimation of the harms.’

For years families have claimed that antidepressant medication drove their loved ones to commit suicide, but have been continually dismissed by medical companies and doctors who claimed a link was unproven.

The review – the biggest of its kind into the effects of the drugs – was carried out by the Nordic Cochrane Centre and analysed by University College London (UCL) who today endorse the findings in an editorial in the British Medical Journal (BMJ).

After comparing clinical trial information to actual patient reports the scientists found pharmaceutical companies had regularly misclassified deaths and suicidal events in people taking anti-depressants to “favour their products”.

Experts said the review’s findings were “startling” and said it was “deeply worrying” that clinical trials appear to have been misreported….”

Tarang Sharma of the Nordic Cochrane Centre, Copenhagen, Denmark admitted: “The analysis suggests that clinical study reports, on which decisions about market authorisation are based, are likely to underestimate the extent of drug related harms.”

Four deaths were misreported by one unnamed pharmaceutical company, who claimed they had occurred after the trials had stopped.

One patient strangled himself unexpectedly after taking venlafaxine but because he survived for five days, he was excluded from the results because it was claimed he was no longer on the trial while he was dying in hospital.”


 

Leonie Fennell is a dedicated patient advocate, and genuine mental health activist, who has done stellar work in bringing awareness to the dangers of SSRI medications (her focus is on the SSRI Cipramil in particular, and Lundbeck the pharma who makes it). Her latest post explores some of the themes which I have mentioned in my post thus far. You can read her full post here, but in the meantime here are some very poignant excerpts from it :

“...Yesterday’s BMJ article that found antidepressants double the risk of suicide and aggression in young people, made headlines worldwide. From America, Australia to india, caution was advised when prescribing in this age bracket. Not so in Ireland. The one newspaper article referring to the BMJ article can be found in today’s Irish Examiner here, entitled ‘Drug link to child suicide queried by expert’. So did it warn prescribers of the suicide and aggression risks, advise stricter guidelines or just advise caution when prescribing to children? None of the latter. Instead the Irish Examiner published an article allowing Professor Patricia Casey to question the findings of the Nordic Cochrane Centre..”


Both the Cochrane group’s report on the doubling of aggression side effects, and suicidal side effects etc, and Leonie’s excellent commentary upon it, is no surprise to me because I experienced these side effects directly from GSK’s notorious Seroxat SSRI. I know just how dangerous these drugs are. Leonie Fennell also knows just how dangerous these drugs are because Cipramil killed her son Shane, and tragically also Cipramil caused Shane to be violent- and as a result of this side effect of SSRI induced violence came the death of Sebastian Creane too. Anyone on an SSRI could end up in Shane’s altered state of mind, I’ve been there, and I know of many others, who have expressed similar experiences. These drugs can make people violent and volatile, they can literally snap your mind. Shane should have been warned and monitored properly for emerging suicidal ideation/akathisa/aggression etc. He wasn’t warned, and neither was his family, and the tragedy that followed could have been prevented had they been.

Although I have been drawing attention to these issues for a long time, it is heartening to see my views legitimized by studies from a group as prestigious and respected as the Nordic Cochrane group. It’s high time the public knew just how dangerous these drugs are for all age groups. The studies highlighting the dangers in adolescents and the young show very clear dangers, however this is the proverbial ‘canary in the coal-mine’. All ages, adults and younger, can experience the same deadly side effects of SSRI’s.

I’m not a huge fan of Peter Hitchens (I preferred his brother- Christopher), however he has been good at covering the dangers of SSRI’s and his latest article on the Cochrane study on SSRI’s pulls no punches in that regard.

http://hitchensblog.mailonsunday.co.uk/2016/01/time-for-some-serious-thought-about-antidepressants.html

Here are some excerpts:

28 January 2016 4:26 PM

Time for Some Serious Thought about ‘Antidepressants’

I expect to have more to say about this, but today’s BMJ? UCL/ Nordic Cochrane Centre analysis of research on ‘antidepressants’ should surely change the terms on which we debate this subject.

I should say that all intelligent people should draw lessons about the difference between what they think is happening, and what is actually happening,  from two major Hollywood films – The Big Short’ and ‘Spotlight’. In both cases – the sub-prime mortgage disaster and the widespread unpunished sexual abuse of children by priests – complacency prevented serious concern for years. In both cases the alarm was raised by outsiders, and most people refused to believe what was being said.

I believe that psychiatric medication contains a similar problem, which in a few years, everyone will acknowledge as fact. But at the moment, it is still difficult to raise it without being accused of being a crank. Complacency rules.

For some years now I have been more or less begging my readers to obtain the book ‘Cracked’ by James Davies’ and to study two clearly-written and straightforward articles on the subject by Dr Marcia Angell, a distinguished American doctor, and no kind of crank, in the New York Review of Books. I link to them (yet again) here. They are devastating, not least because of their measured understatement. The alleged scientific theory (the Serotonin theory) which underpins the prescribing of such drugs is, to put it mildly, unproven. The drug companies themselves have kept secret (until compelled to disgorge them by FoI requests) research results which suggest their pills are, again to put it mildly, not that effective.

http://www.nybooks.com/articles/2011/06/23/epidemic-mental-illness-why/

http://www.nybooks.com/articles/2011/07/14/illusions-of-psychiatry/

Dr Angell’s articles are themselves reviews of important recent books on the subject.

I have also drawn attention to the huge sums of money involved, and to a recent case in which a major drug company was fined *three billion dollars* for (amongst other things) mis-selling ‘antidepressants’.

http://www.theguardian.com/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals


Hitchens is astute in his analysis of the Cochrane study. He draws attention to what I have been drawing attention to on my blog for 9 years. The reason why these drugs have been so widely promoted boils down to one thing- money.

The pharmaceutical industry makes billions on them, that’s why they have got away with all these years of cover-ups, lies, death and destruction. Psychiatry would lose its status (and its profitability) as a ‘legitimate medical specialty’ without the drugs- that’s why they deny the problems- even in the face of overwhelming evidence against their use. For psychiatry – raising awareness of the dangers undermines the profession… and we all know how highly paid some psychiatrists are don’t we?…

Nobody likes their bread and butter threatened do they?…

Nope..

Money, it’s a crime
Share it fairly but don’t take a slice of my pie
Money, so they say
Is the root of all evil today
But if you ask for payrise it’s no surprise
That they’re giving none away
Away, away, way
Away, away, away

(Pink Floyd – Money)

GlaxoSmithKline’s $3 Billion Hit: Deterrent or Business Expense? (from Forbes)


http://www.forbes.com/sites/robwaters/2012/07/12/glaxosmithklines-3-billion-hit-deterrent-or-business-expense/

PHARMA & HEALTHCARE 7/12/2012 @ 10:55AM 11,740 views

GlaxoSmithKline’s $3 Billion Hit: Deterrent or Business Expense?

Eight years ago, I wrote a cover story for the Sunday magazine of the San Francisco Chronicle. It began with the story of a teenage girl I called Angela Reich who became depressed after enduring months of grueling chemotherapy for leukemia. She resisted suggestions that she try antidepressants and saw a therapist for a while but her sadness and despair didn’t lift. So she relented and saw a psychiatrist, who started her on Paxil, an antidepressant made by the British pharmaceutical company GlaxoSmithKline.

The doctor increased the dose a little at a time, even after Reich told him she was feeling strange in her body and worse than she had before. She became increasingly anxious and jittery, with a relentless discomfort inside her body that caused her to constantly shake her leg. Finally, one morning, she attempted suicide by trying to swallow multiple doses of Ativan, Paxil and other medications she found around her house. Her father broke down the door of the bathroom, interrupting her pill-binge and rushed her to the hospital. His action may have saved her life.

Other teenage Paxil users were not so lucky. Jake Garrison, a 15-year-old who suffered from acne, was prescribed Paxil by his dermatologist for “body dysmorphic disorder,” a condition that leaves people feeling preoccupied with their own perceived physical defects. He took the medicine for a while, then stopped, and then, in September 2002, began taking it again. Three days later, he shot himself to death.

As I looked into the story at the time, several things became clear: GlaxoSmithKline was promoting the drug for use by teenagers even though it had never been cleared by the FDA for anyone under 18. The company also knew—but hadn’t revealed to doctors and patients—that, in some children, Paxil seemed to magnify their distress and increase their risk of thinking about or attempting suicide. GSK also seemed to be manipulating data from its clinical trials to minimize the number of suicides or attempts that might be blamed on its pills—“cooking the books,” in the words of a former Navy lawyer who took on the British pharma giant.

Last week, the U.S. Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion in criminal and civil fines for its misdeeds in inappropriately marketing Paxil and another antidepressant, Wellbutrin; for withholding information on the cardiovascular risks of Avandia, a diabetes drug that has been shown to cause heart attacks; and for promoting Advair, an inhaled lung drug, to patients with mild asthma even though it wasn’t approved or appropriate for them. The fine was the largest ever imposed by the U.S. on a pharmaceutical company and settled both civil and criminal charges.

The settlement agreement and the attached documents were full of juicy details that have now been widely reported: How GSK orchestrated the publication of a “misleading,” ghost-written study purporting to show that Paxil helped children when evidence suggested the opposite. How the company paid doctors, including “Dr. Drew” Pinsky, to promote Wellbutrin and how sales reps pitched Wellbutrin to doctors as the “happy, horny, skinny drug,” claiming it was also good for obesity and sexual dysfunction although it was approved only for depression.

As I read through company documents released by government lawyers, I began thinking about some of the victims I’ve interviewed during two decades of reporting on the pharmaceutical industry and its marketing of flawed, sometimes dangerous drugs—people like Angela Reich and the anguished parents of other children who died. I also thought about the statements made by Sir Andrew Witty, Glaxo’s chief executive officer, who expressed “regret,” said the company had learned from “the mistakes that were made” and asserted that under his leadership the company was now “putting patients first, acting transparently…and displaying integrity in everything we do.”

I wanted to talk to some of the people who had been harmed by taking GlaxoSmithKline’s drugs and the lawyers who represented them to see how they felt about the company’s admission of guilt and its $3 billion fine. First, I connected with Angela Reich, who was back in the Bay Area from an eastern school where she is now pursuing a PhD in literature. (She again asked that her name be changed, as it was when I first wrote about her in 2004.)

She recalled her Paxil experience and her subsequent effort to wean herself from the drug as a nightmare, and was outraged that the company failed to warn patients about the dangers.

“I think it’s despicable what they did and I think a $3 billion fine is pathetic,” when the company’s earnings are considered, she told me. “No specific individual executive has been prosecuted or punished or fined; there’s nothing to take away the incentives for huge drug companies to commit fraud. I’m infuriated.”

In fact, Glaxo’s legal and financial liability goes beyond the DOJ settlement. The company has been hit with jury verdicts and settled thousands of cases alleging that Paxil caused suicides, addiction and birth defects in babies whose mothers using the drug during pregnancy. A couple of years ago, my former colleagues at Bloomberg News estimated that Glaxo had paid out about $1 billion to settle Paxil-related cases. That was before a raft of birth-defect cases had been settled or tried.

Michael Baum, a partner at Baum-Hedlund, a Los Angeles firm that handled some of those cases, told me about 1500 had settled and a few remained. Both he and Sean Tracey, the Houston attorney whose firm handled most of the birth-defect cases, declined to estimate the value of the settled cases because they were made secret under the terms of the settlements.

Then there’s Avandia. Baum thinks that GSK’s apology and partial admission of guilt may make it harder and more expensive for the company to settle a number of still-unsettled Avandia cases. He estimated the number at about 1800 and says his office is involved in 180 of them. About 50,000 Avandia cases have been settled.

“Their admissions in the plea agreement and the information (the criminal complaint) puts GSK’s experts and corporate representatives in a corner,” Baum said. “It makes it difficult for them to say they did not hide information from physicians.”

As part of the plea agreement, the company made a commitment: it had to pledge that its executives won’t lie in the future. That requirement, Baum said, “is going to make it difficult for them.”

So will the penalties imposed on GSK really deter nefarious behavior in the future? Baum agreed with his former client, Angela Reich, that while the fine itself is serious money, it doesn’t compare to the revenue the company made from fraudulent marketing. “The public exposure of the conduct may be more of a deterrent than the fines,” Baum said.

Last year, GSK had a net profit of 5.3 billion pounds ($8.2 billion) on revenue of 27.4 billion pounds ($42.6 billion). Paxil, which entered the U.S. market in 1993, had sales of $11.7 billion in the nine years starting in 1997. Avandia came on the market in 1999, reached peak annual sales of $3 billion in 2006, then fell to $1.2 billion in 2009, two years after a study in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attack.

“If pharma companies can flout the law and then simply write a check when they get caught, they’re never going to stop,” said Sean Tracey. “The money is too large. Until and unless someone’s liberty comes to jeopardy, they simply consider this the cost of doing business.”

The full set of documents relating to GSK’s suppression of information on the cardiovascular risks of Avandia has still not come to light and GSK is still working to keep those documents under wraps, Baum said.  “They’re fighting us on releasing these documents that show what really happened,” he said. “They should allow the press and the public to see them.”

Tracey, meanwhile, is gearing up for another battle. Two years ago, he won a $2.5 million judgment against GSK for the family of a three-year-old boy, Lyam Kilker, whose mother took Paxil while she was pregnant. He subsequently settled 35 other cases. Now, on behalf of 150 clients, he is preparing to take on Pfizer, the maker of Zoloft, an antidepressant that came on the market around the same time as Paxil, and has also been alleged to cause birth defects. Stay tuned.

FBI Interviews Glaxo Employees


http://online.wsj.com/articles/fbi-interviews-glaxo-employees-1406319760?mod=rss_whats_news_us

Federal Bureau of Investigation agents have been interviewing current and formerGlaxoSmithKline GSK.LN -3.16% PLC employees in connection with bribery allegations made against the drug maker in China, according to a person familiar with the matter, as fresh claims of corruption surfaced against Glaxo’s operations in Syria.

The interviews have taken place in Washington, D.C., in the past few months and are part of a Justice Department investigation into Glaxo’s activities in China, the person added.

The U.S. Securities and Exchange Commission also is investigating the company’s business in China, according to people familiar with the matter. Spokeswomen for the SEC and FBI separately declined to comment.

Chinese authorities have accused Glaxo’s former top executive in that country, U.K. national Mark Reilly, of “large-scale” bribery. Mr. Reilly couldn’t be reached for comment and hasn’t commented in the past.

Glaxo said it is cooperating with the Chinese authorities, and has informed the Justice Department and the SEC of the Chinese investigation. A spokesman for the company declined to comment on the FBI interviews and said Glaxo’s discussions with regulators were confidential.

The U.K.’s Serious Fraud Office also is investigating Glaxo for possible criminal violations in its commercial practices, the company said in May.

Last week, Glaxo received an anonymous email claiming its employees in Syria bribed doctors and pharmacists over the past five years to promote products including painkiller Panadol and toothpaste Sensodyne.

The bribes took the form of cash payments, speaking fees, trips, free dinners and free samples, said the email, which was reviewed by The Wall Street Journal. The email cited names and dates.

Doctors promoting Glaxo’s cold and flu products were paid $2,500 in cash in December 2010, the email says, while $2,500 was paid to a national dental association in return for getting Glaxo’s Sensodyne logo on dentists’ prescription notepads.

Syrian health officials allegedly received bribes from Glaxo employees to fast-track registration of its Sensodyne dental products, including cash payments and a trip to a 2011 conference in Rome, the email maintains.

Glaxo employees also were involved in smuggling a narcotic product from Syria into Iran, the email alleges.

The product in question, pseudoephedrine, is a raw ingredient of Glaxo’s congestion medicine Actifed and can also be used in the production of methamphetamine. The Syria allegations was reported by Reuters on Thursday.

Glaxo’s consumer-health operations in Syria—where the bribery allegations are being made—were closed in 2012 as the country’s civil war worsened. Glaxo retains its prescription-medicine operations in Syria.

Glaxo said it would thoroughly investigate all claims made in the Syria email, and said it has asked the sender for more information. The company said it has zero tolerance for unethical behavior, adding, “We welcome people speaking up if they have concerns about alleged misconduct.”

The SEC has recently started giving whistleblowers a cut of any settlement reached as the result of allegations detailing securities-law violations—providing a financial incentive for anyone with concerns to step forward.

Under the U.S. Foreign Corrupt Practices Act, which falls under the SEC whistleblower program, it is illegal for companies with significant U.S. operations to bribe foreign officials in exchange for business. In 2010 Glaxo disclosed it had been contacted by the Justice Department and the SEC about its overseas operations as part of a wider FCPA investigation into pharmaceutical-industry business practices abroad, including in China. The agencies also began investigating the more recent allegations in China last year, according to people familiar with the matter.

The Syria email follows allegations of bribes paid by Glaxo employees in China, Iraq,Jordan, Lebanon and Poland in the past 12 months.

The tens of thousands of dollars in bribes allegedly paid in Syria are on a much smaller scale than the allegations in China, where officials last July alleged Glaxo had funneled bribes totaling $480 million through travel agencies.

Glaxo said it takes all bribery allegations in any country seriously. Last year, it announced an overhaul of its marketing practices, including stopping all payments to doctors to attend conferences or speak about its drugs. Earlier this week, Glaxo cut its full-year earnings outlook after second-quarter profits were hit by weak U.S. sales of its respiratory drugs, currency headwinds and falling sales in China.

Glaxo’s shares are down almost 12% for the year to date.

GSK Corruption and Criminality Has Been Going On For Decades..


 Corruption in China and Iraq, Defective Drugs...
GSK criminality and corruption has been
going on for decades before these 
current scandals..

The following are but a small sample..
...they don't call them the 'Global Serial Killers'
for nothing you know...

http://www.whale.to/v/gsk3.html

GlaxoSmithKline
GlaxoSmithKline

[Satanic is the only word that does justice to this outfit (see Lucifer symbol over Wellcome building, below), one example:  After their Trivirex MMR vaccine was withdrawn as dangerous in Canada, in 1988, they managed to get it on the UK market with a government indemnity, under another name: Pluserix (see MMR timeline).   When that had to be withdrawn they then sold it to the third world (causing an outbreak of meningitis in Brazil), while they have done their best to suppress the fact it caused autism and bowel disease, along with the present MMR vaccines. Sir Nigel Davis, who dismissed the appeal over the removal of funding for the MMR litigation by the Legal Services Commission, was the brother of Lancet proprietor Crispin Davis who at the time had also recently become a non-executive director of Glaxo SmithKline. The Times group (whose CEO is James Murdoch, appointed in 2009 a non executive director with GlaxoSmithKline) through it’s journalist Deer, is leading the attack on Dr Wakefield that culminated in the GMC Kangaroo court.
Of course the big poison in their history is AZT which they are still trying to kill Africans with.  Recently caught suppressing adverse effects with Avandia.  One psychiatric poison is Paxil/Seroxat.  God willing, this one is going to crash and burn on its way down to hell . Sell your shares now.]

Interestingly, this way of covering up the reality of deaths and damage caused by pharmaceutical corporations is becoming more common — In the UK, the case against Dr Andrew Wakefield, the whistleblower in the case of MMR (manufactured in part by GSK), was presented to the public as one of ethics, while the real issue of a damaging vaccine which harmed thousands of children was completely sidelined. If Witty and GKS did learn anything from this case, it was how to get away with culling the population of thousands, this part of their operation went very well but next time they might hope to dodge the fine for undeclared safety data. It makes me sick to my stomach, that while every high school shooting, every soldier killed in a foreign country, every notorious murder is religiously reported by the US media, GSK gets away with killing thousands without a single adverse word. And where are our gallant reporters in all this, whose going to sue them for fraudulent reporting, nothing could be a clearer sign that the media and it’s feather bedded journalists have crossed to the other side of the corporate tracks.
    
Getting away with murder II.(in two parts) Because of clever media manipulation, most people don’t understand what this ‘fine’ involved in the GSK mass murder case. It has been presented to the public as a case of fraud. Every news item makes clear that GSK failed to disclose certain safety data for three drugs which they produced. The penalty for this fraud, however, was only a portion of the overall ‘settlement’, the great majority of it was a straightforward claims settlement for deaths and injury caused to people who took the drugs after they had been licensed on fraudulent safety data (I know only about Avandia, for one of the other drugs see Fiona Hackman’s question below).It’s a little like an automobile company knowingly producing cars with faulty brakes, which ultimately kill thousands of people, being fined for failing to alert industry regulators to an apparent production fault. The reason why all media have reported this settlement as one of fraud is clear, had it been reported as a claims settlement even the most docile of the public would have raised eyebrows, asking the question, ‘How can a company falsify safety data, obtain a license for a drug and watch it kill and maim thousands of people?’ Mr ‘witty’ Witty, the Chief executive of GSK was able to brush off the whole settlement with the aside ‘We’ve learned from our mistakes’, when the sad fact is that it was thousands of others who learned by GSK’s criminality.Martin Walker MA  Martin Walker

“Three months ago we announced a partnership with the Wellcome Trust to invest over £1 billion to re-equip university science in Britain, the largest ever investment in Britain’s science base. Having received an overwhelming response from universities to our new University Challenge Fund we are now inviting further private sector involvement.”—Chancellor’s statement Nov 4, 1998

What is not commonly known is that the developers of the “dye”, Kodak, knew it would cause CIAA before they licensed it (May 1944).Today, there are 80 medical conditions or symptoms that have been recognised as a “cause or effect” of exposure to this “too toxic” chemical dye (NIH, 1994). Many of the drugs now used to treat these secondary conditions or symptoms of CIAA have been developed or patented by those who developed the original formula (for some, with slight changes of said formula; later, for instance, Myodil by GlaxoSmithKline).
    I will go on the record to state the following: the developers of the diagnostic radiographic contrast medium knew before they applied for an NDA (new drug application) that it would cause arachnoiditis, and furthermore were aware of some of the other found reactions to this “dye” that were also not reported to the authorities.
    I will go further and also place on the record that the collection of “secret studies” shows such; however, none was ever submitted to the FDA when applying for the NDA. Copies of all these “secret studies” are held in a bank safe on my behalf; these can be made available to any person who is willing to publicly publish such. [Letter Nexus Dec 2006] Arachnoiditis Awareness

The files containing the licensing history of Myodil have been ‘mislaid’ by the Medicines Control Agency. After pressure from the Myodil Action Group, which fought for an investigation, the Parliamentary Ombudsman recommended a release of the documents. However, the Permanent Secretary to the Health Department refused to release the major part of the Myodil licensing documents.
    On the 19th September 1988 Glaxo notified the Department of Health that Myodil was to be discontinued in the UK for commercial reasons, but they wished to retain the product licence issued in June 1987 as the product was not being discontinued worldwide. Myodil is thus still manufactured and sold overseas – it has found new markets in countries that are vulnerable to the marketing strategy that made Glaxo one of the largest pharmaceutical companies.
    Glaxo has always maintained that the links between Myodil and adhesive arachnoiditis have not been proven. But in an out of court settlement in 1995, whilst denying liability Glaxo Laboratories Limited paid out, on average, £16,000 to each of 425 claimants suffering from Myodil Adhesive Arachnoiditis. A further 3,000 claimants had to withdraw because of what many of them felt to be Glaxo’s solicitors’ bullying tactics. Settling out of court meant that Glaxo effectively closed the door on any further litigation in the UK.[2000] Toxic drugs are good for you (Myodil)

The Daily Telegraph has documentary proof the Federal Government, state health authorities and doctors sanctioned the use of the dye even though they knew the devastating effects of the chemicals in it. ……“You’ve seen the chemical make-up of the substance – it contains benzene, hydrochloric acid and sulphuric acid,” he said. “How could they ever think that injecting those chemicals into somebody’s back would not be harmful?” Doctors were warned not to spill the chemical on rubber because it destroys it and dissolves polystyrene cups. [2002] Medical cover-up

“Dr. Samuel Katz of Duke University  has served as chair of both the ACIP and the Red Book committees. He co-chairs a group called the Vaccine Initiative, which is an information and advocacy group that benefited from start-up funds from at least six vaccine manufacturers. He is listed as an advisory board member to the Immunization Action Coalition (which includes the Coalition for Hepatitis B), an advocacy group that receives funding from several vaccine makers, including SmithKline Beecham, Merck and Wyeth-Lederle……..Dr. Neal Halsey of Johns Hopkins University http://www.vaccinesafety. Like Katz, he is a vaccine pioneer and served on ACIP and the Red Book committees. He, too, is an advisor to the Immunization Action Coalition and the Hepatitis B Coalition. Halsey is also director of the Institute for Vaccine Safety, which he founded at Johns Hopkins to provide a forum on vaccine safety, among other things. According to a Johns Hopkins’ spokesperson, the institute receives funds from Merck, SmithKline Beecham, North American Vaccines, Connaught/Pasteur Merrieux and Wyeth-Lederle.”—-Nicholas Regush ABCNEWS.com

“NCK & GHCWaters pointed out that the confidential study’s lead author, Thomas Verstraeten, has since left the Centers for Disease Control and is now employed by GlaxoSmithKline, a manufacturer of thimerosal containing vaccines for many years that is a defendant in numerous suits pending nationwide.  “We have asked GlaxoSmithKline to provide Mr. Verstraeten’s deposition in order to understand if conflict of interest issues may have played a role in the CDC’s decision to keep this report confidential, and specifically, their failure to reveal it to the Institute of Medicine.”–AUTISM DAILY NEWSLETTER Thursday January 3, 2002

“In the latest annual report for the “Medicines Act 1968 Advisory Bodies”, she (Miller) lists five “non-personal” interests — payments which benefit her department rather than herself personally. They are grants from Baxter Healthcare, Wyeth Lederle Vaccines, Chiron Biocine, and SmithKline Beecham and “CMI testing in adolescent sera”, courtesy of Aventis Pasteur.”–Private Eye

“Professor  David Elliman, whose study said fears of a link between the MMR vaccine and autism were unfounded, admitted that he and Dr Helen Bedford had been given money by drugs giants SmithKline Beecham and Pasteur Merieux Merck Sharp & Dohme. Their report, MMR Vaccine – Worries Are Not Justified, is published in the current issue of the medical journal Archives of Disease in Childhood, and was used by the government to reiterate its view that the vaccine is safe.”–Media  

“Wyeth Lederle had paid Dr. Edwards $255,023 per year from 1996 to 1998 for the study of pneumococcal vaccines (i.e. Prevnar). Edwards is also one of fifteen full-time members of FDA’s Vaccines and Related Biological Products Advisory Committee, the committee that advises the FDA on the licensing of new vaccines……Rennels was instrumental in getting RotaShield to market and is now involved in Prevnar. Her university receives a total of over $2.5 million from various drug and vaccine companies including Wyeth Lederle, Prevnar’s manufacturer. She is also one of the twelve members of the Committee on Infectious Diseases, the committee that makes vaccine recommendations as part of the American Academy of Pediatrics…..This doctor (Dr. Jerome Klein) has been employed by the major vaccine manufacturers to testify against vaccine injured children. He is also chief editor of pneumo.com the website paid for by Wyeth Lederle to sponsor Prevnar. Furthermore, Klein holds a position on the National Vaccine Advisory Committee, the committee that recommends products for universal vaccination.”–Michael Horwin, MA

“A Sunday Express investigation has found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA) committees are linked to GlaxoSmithKline, Aventis Pasteur or Merck, Sharpe and Dohme.”–Sunday Express

“Currently, 37 members of the CSM have a total of 188 separate financial links with the pharmaceuticals industry, inc the vacc manufacturers, including 82 separate personal declared links. These include shares, fees, consultancies, research grants and non-executive directorships. Also further 106 non-personal declared links. Source: Neill Committee on Standards in Public Life). Vaccine companies directly linked to members of CSM through personal declared financial links include SmithKline Beecham (NB), Merck Sharpe Dohme (NB), Lilly Industries, Pfizer, Glaxo Wellcome (NB), Bayer, Proctor 7 Gamble, British Biotech, Medeva Pharma. Members with personal financial links with MMR manufacturers are Messrs Blenkinsopp, Dargie, Donaghy, Evans, Forfar, MacGowan, Smyth, Wilkie. (Source: Neill Committee on Standards in Public Life).”–David Thrower Flawed UK Regulatory and Monitoring Systems (2001)

“A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed the following declared interests within the JCVI membership (NB – the PWQ related only to a limited range of pharmaceuticals companies, so the full list will be greater than this): Professor Lewis Ritchie (Glaxo Wellcome), Dr. Barbara Bannister (Glaxo Wellcome and SmithKline Beecham),  Dr. David Goldblatt (SmithKline Beecham), Dr. Diana Walford (Glaxo Wellcome and SmithKline Beecham), Professor Roy Anderson (Glaxo Wellcome and SmithKline Beecham), Dr. Karl Nicholson (Glaxo Wellcome)”–David Thrower Flawed UK Regulatory and Monitoring Systems (2001)

“The MCA is of course headed by a former top executive at SmithKline, Dr Ian Hudson.”–Private Eye

“5 out of 6 members of the (UK) Joint Committee on Vaccination and Immunisation had interests with Glaxo Wellcome, 4 with SmithKline Beecham (ref: May 1999 Secretary of State for Health)

AMERICAN ACADEMY OF PEDIATRICS http://www.cspinet.org/integrity/corp_funding.html
“Friends of Children Fund” Annual Report, July 1, 1996 – June 30, 1997, indicates $2.085 million in funding from corporations. Donors include Procter & Gamble, Gerber, Infant Formula Council, McNeil Consumer Products Company, National Cattlemen’s Beef Association, Johnson & Johnson Consumer Products, Abbott Laboratories, Wyeth-Lederle Vaccine & Pediatrics, Mead Johnson Nutritionals, SmithKline Beecham Pharmaceuticals, Schering Corp., Rhone-Poulenc Rorer, Food Marketing Institute, Sugar Association, International Food Information Council, Merck Vaccine Division, and others. Also gets foundation support (RWJ, Pew, etc.).

“Lemon S, Thomas DL. Vaccines to prevent viral hepatitis. N Engl J Med 1997;336:196-204. Dr. Lemon received grants from SmithKline Beecham Pharmaceuticals.“–NEJM

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1boringoldman Blog: ‘The Whole Industry’… (If Glaxo’s CEO wants to be Mr. Clean, he needs to pick up a broom )


Great post from the retired psychiatrist from his blog 


1boringoldman
Always astute and wise,

 very insightful blog

 and very much appreciated writing..

Great to see that there are  other people out there who see

 through
 
GSK's lies..

 http://1boringoldman.com/index.php/2014/04/07/the-whole-industry/

the whole industry…

Posted on Monday 7 April 2014

Fierce PharmaMarketing
By Tracy Staton
April 7, 2014

GlaxoSmithKline [$GSK] says it’s rolling out sales and marketing reforms around the world. Apparently, the changes come none too soon. The British drugmaker opened another bribery investigation, this time in Iraq, to check out allegations that it paid government-employed physicians to promote its products. And Glaxo hasn’t yet finished working through the scandalous Chinese bribery allegations that kicked off an industry-wide corruption crackdown.

So, CEO Andrew Witty and his team sound a bit … conflicted. On the one hand, Witty sounds the perfectly contrite corporate leader. He apologized for the marketing allegations that ended with a $3 billion Department of Justice settlements. He’s promised good behavior and touted those worldwide sales reforms. But on the other, the company is digging into at least two sets of corruption accusations, and faces related repercussions at home and in the U.S. Two bribery probes in two different geographic divisions? That’s a systemic problem.

When the Chinese bribery scandal hit, Glaxo’s U.K. headquarters was quick to say that head-office executives didn’t know about any malfeasance in its China subsidiary. That may be so. But if HQ didn’t know, that means HQ was either turning a blind eye or failing to pay enough attention. Either way, that’s not a good thing for a company trying to clean up its image.

If Witty really wants to reform GSK, then he and his top managers need to move beyond plausible deniability. They can’t just launch new quota-free sales-rep compensation and promise to stop paying speaking fees to doctors in the U.S. and beyond. Painful follow-through has to happen.

We need to see Glaxo execs take out their brooms, and move into global operations to sweep out misbehavior. If they don’t, whistleblowers and government investigators will. And that makes all those the sales-and-marketing changes look like little more than window-dressing.
Just a fluff piece to fill a column? I don’t think so. I think Tracy Stanton is on to something that Sir Andrew Witty and others need to listen to carefully. I don’t think the time honored method of putting a few platitude band-aids on a problem and waiting for the news cycle to pass is going to work very well. We’re onto that maneuver – a lesson learned in the school of hard experience. I was looking over some old posts and ran across any number of excuses, press releases, and statements in response to accusations in years past, and most of them would be laughed at these days or at least send eyes rolling. And plausible deniability is on top of the list of worn out spinning wheels. Two early versions came from my favorite bad example, Dr. Charles Nemeroff, when he was busted for leaving out conflict of interest declarations:
New York Times
By MELODY PETERSEN
August 3, 2003

Two scientists are raising concerns about an article in a medical journal that described experimental treatments for depression because an author did not disclose his significant financial ties to three therapies that he mentioned favorably. The executive editor of the journal said it had not required disclosure of the potential conflicts, but was considering changing its policy in light of the criticism. The ties between pharmaceutical companies and researchers have come under increasing scrutiny in recent years.

The lead author of the article, Dr. Charles B. Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory School of Medicine in Atlanta, said he would have reported the conflicts of interest, which include owning the patent on a treatment he mentioned, if the journal had asked him to. ”I have always been totally compliant, probably gone overboard, with disclosure,” Dr. Nemeroff said. ”If there is a fault here, it is with the journal’s policy.”
The Wall Street Journal
By David Armstrong
July 19, 2006

Charles Nemeroff, one of the nation’s most prominent psychiatrists, edits the journal Neuropsychopharmacology, which this month favorably reviewed a controversial new treatment for depression. But Tuesday, the journal said it plans to publish a correction because it failed to cite the ties of the article’s eight academic authors to the company that makes the treatment, including the article’s lead author: Dr. Nemeroff.

The journal’s nondisclosure of the financial ties of its own editor as well as those of the other authors highlights the failure of many respected medical journals to identify relationships between academic researchers and medical companies that may benefit from positive research reports. A spate of recent lapses is prompting calls for more journals to ban offending authors from publication. In addition, medical schools are being urged to regulate relationships between their researchers and industry more closely…
His excuse that second time – clerical error. It didn’t work so well as the first one and he decided to step down as editor shortly thereafter. We can thank Drs. Bernard Carroll and Bob Rubin for both of those exposures. They came early and got the ball rolling. The investigations of Senator Grassley and Paul Thacker came next, and then the epidemic of suits against the Pharmaceutical companies with the release of enough incriminating documents to convince any doubters. So we’re now veterans of ten years learning that plausible deniability simply equaled a lie, and we’re not likely to buy such things anymore, almost by reflex.

I was a retired person before I was capable of believing that Doctors, Academic Department Chairmen, and Pharmaceutical Companies named after long-dead men with handle-bar mustaches were capable of the kind of deceit we’ve all seen in recent decades – but our naivety has given way to, at the least, a careful suspiciousness, even paranoia about such matters. And GSK has placed itself in a goldfish bowl that’s going to be hard to escape.

So when Tracy says, “We need to see Glaxo execs take out their brooms, and move into global operations to sweep out misbehavior” she’s not just moralizing, she’s giving GSK an appropriate heads up they really need to hear – not just GSK, the whole industry. We’re veterans now…

GlaxoSmithKline and Roche won’t disclose their results (2013)


A year ago GSK announced that they would give access to their clinical trial data, and pundits like Ben Gold-acre praised them to the public,  for ushering in this so called ‘new era’ of transparency…

But astute observers are aware that GSK are playing this data game only on their terms… and transparency is determined strictly by their definition… they control the game…

and of course, ultimately this game will all play out to the tune of their agenda…

2014 should be intriguing…

 

 

http://www.bmj.com/content/346/bmj.f819/rr/633959

 

GlaxoSmithKline and Roche won’t disclose their results

5 March 2013

GlaxoSmithKline (GSK) and Roche have declared they are willing to disclose their trial data. But not like the European Medicines Agency, which from January 2014 will provide public access to the full clinical study reports for all new drugs, the corresponding protocols, and the raw data in statistical programmes and the codes – without conditions.

If we shared our data, it would lead to tremendous progress for public health (1). But this is not what GSK (2) and Roche have announced (3). The companies will establish committees of “experts” that will decide whether people can get access to patient level data. And GSK will only allow access after it has published the trials. What about trials that never get published?

Does anyone really believe that the companies will allow access to the data if the research could potentially show that one of their blockbusters is so dangerous that the drug agencies will withdraw it? Or that Roche is willing to run the risk that governments won’t buy any more Tamiflu after they have seen the data?

Instead of providing the full clinical study reports, GSK will take the trouble to strip out all patient level data. This means we won’t be able to detect when GSK has manipulated their analyses, which they and other companies often do. Here are some examples related to GSK:

1) Not only GSK, but also Eli Lilly and Pfizer, added cases of suicide and suicide attempts to the placebo arm of their trials of antidepressants, although they didn’t occur while the patients were randomised to placebo (4-8). Professor David Healy pointed this out, and it wasn’t denied by the companies but GSK instead called Healy’s analysis “scientifically invalid” and “a disservice to patients and physicians” (9).

2) Cases of suicidality were coded as hospital admission, drop-out, worsening of depression or emotional lability by several companies (4). In the BBC Panorama series about paroxetine, Glaxo’s spokesperson, Dr Alastair Benbow, denied in front of a running camera that paroxetine could cause suicidality or self-harm but one month later he sent trial data to the UK drug regulator that showed exactly this, which immediately led to a ban on using the drug in children. GSK stated that they “detected no signal of any possible association between Paxil and suicidality in adult patients until late February 2006,” but US government investigators found that the company had the data back in 1998 (10).

3) GSK denied for years that paroxetine was habit forming, although paroxetine led to withdrawal reactions in 30% of the patients in the original licence application (11). In 2003, GSK quietly and in small print revised its previous estimate of the risk of withdrawal reactions in the prescribing instructions from 0.2% to 25% (12), a 100 times increase.

4) Glaxo’s trial 329 of paroxetine in children and adolescents was negative for efficacy on all protocol specified outcomes and positive for harm but data massage produced four statistically significant effects after splitting the data in various ways (13,14). The paper falsely stated that the new outcomes were declared a priori. At least eight children became suicidal on paroxetine versus one on placebo, but in the published paper, five cases of suicidal thoughts and behaviour were listed as “emotional lability” and three additional cases of suicidal ideation or self-harm were called “hospitalisation.” The abstract of the paper concluded that “Paroxetine is generally well tolerated and effective.” Trial 329 was widely believed and cited (184 times by 2010), and it lured many doctors into using paroxetine for childhood depression, although the drug is harmful. The trial has not been retracted despite repeated calls on the journal to do so. The Attorney General of New York State sued GSK in 2004 for repeated and persistent consumer fraud in relation to concealing harms of paroxetine, and GSK was required as part of a legal settlement to make the individual patient level data from that trial available, but they didn’t do so. Only when Dr Peter Doshi contacted the New York Attorney General’s office in 2012 and said that the data weren’t there, did the data get posted. The clinical study report is now available on GSK ‘s home page (http://www.gsk.com/media/resource-centre/paroxetine/paroxetine-paediatri…) and it contains revealing narratives of serious adverse experiences. For some unexplained reason, the four authors of GSK’s study report have been replaced by xxxxx x xxxxxx, B.S.*, xxxx xxxxx, Ph.D.*, xxxxx x xxxxxxxxxx, B.S.*, xxxxxxxx xxxxx, M.S.**.

5) An FDA scientist found that the adjudication of cardiovascular events in the RECORD trial of rosiglitazone was seriously flawed. He found many missing cases of cardiac problems that favoured rosiglitazone four to one (15,16) and that rosiglitazone increased cardiovascular risk, in contrast to Glaxo’s results. He concluded that the case report forms are essential for understanding a study and noted that, “even with blinded adjudication, biased referral for adjudication of cases and data by unblinded investigators and site monitors may lead to biases in event rates” (16). In 1999, the company, then known as SmithKline Beecham, completed a trial that found more cardiac problems with rosiglitazone than with pioglitazone, but according to an internal email, “These data should not see the light of day to anyone outside of GSK” (15,17). The company spent the next 11 years trying to cover them up (17).

6) Because of concerns that long-acting beta-agonists might increase asthma-related deaths, the FDA asked GSK to carry out a large trial of salmeterol, the SMART trial. The trial period was 28 weeks, but the investigators could – if they wanted – report serious adverse in an additional 6 months period. The FDA assumed that the data they reviewed stemmed from the trial period, and only when the agency asked, did GSK reveal it had included the follow-up data. There was no statistically significant increase in asthma-related deaths in Glaxo’s analysis, whereas the risk was four times higher for the trial data, which was statistically significant (18).

7) In 2008, Professor Jens Lundgren received a death threat at the international AIDS congress in Mexico City in an SMS before he presented data showing that Glaxo’s £600 million drug, abacavir, almost doubles the risk of heart attacks (19,20). As soon as Lundgren had finished his talk, he was escorted to the airport with eight body guards. It was not possible to trace where the death threat came from.

Right now, the drug industry fights tooth and nail against access to trial data. In relation to the proposed revision of the EU Clinical Trials Directive the industry argues that a summary of the results is all that is needed, although we know we cannot trust summaries. We cannot trust the industry either when it says it’s committed to full transparency (3):

“Roche is supporting the European Medicines Agency (EMA) in its commitment to the proactive publication of data from all clinical trials supporting the authorisation of medicines.”

If Roche was serious about this, then why the obstacles?

References

1 Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12(1):249.

2 Kmietowicz Z. GSK backs campaign for disclosure of trial data. BMJ 2013;346:f819.

3 Roche launches new process for accessing clinical trial data. Press release 2013 Feb 26.

4 Healy D. Let them eat Prozac. New York: New York University Press, 2004.

5 Healy D. SSRIs and deliberate self-harm. Br J Psychiatry 2002;180:547.

6 Healy D. Did regulators fail over selective serotonin reuptake inhibitors? BMJ 2006;333:92-5.

7 Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry. 2003;183:22-7.

8 Lenzer J. FDA to review “missing” drug company documents. BMJ 2005;330:7.

9 Rockhold F, Metz A, Traber P. Response from GlaxoSmithKline. Br J Psychiatry 2002;180:548.

10 Grassley CE. Paxil. Speech at the US Senate 2008 June 11.

11 Herxheimer A, Turbulence in UK medicines regulation: A stink about SSRI antidepressants that isn’t going away. Chapter 10. In: Glavanis K, O’Donovan O (eds). Power, Politics and Pharmaceuticals: Drug Regulation in Ireland in the Global Context. Cork University Press, 2008.

12 Medawar C, Hardon A. Medicines out of control? Antidepressants and the conspiracy of goodwill. Netherlands: Aksant Academic Publishers, 2004.

13 Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008;20:73-81.

14 Jureidini JN, McHenry LB. Conflicted medical journals and the failure of trust. Accountability in Research 2001;18:45-54.

15 Cohen D. Rosiglitazone: What went wrong? BMJ 2010; 341:530-4.

16 Psaty BM, Prentice RL. Minimizing bias in randomized trials: the importance of blinding. JAMA 2010; 304:793-4.

17 Harris G. Diabetes drug maker hid test data. New York Times 2010 July 13.

18 Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet 2005;366:1261-2.

19 Glaxo ‘downplayed’ warning on heart-attack risk from AIDS drug. The Independent 2008 May 12.

20 Brix SM. [Researcher receives death threats]. Universitetsavisen 2008;14:5.

Competing interests: None declared

http://1boringoldman.com/index.php/2013/03/08/cat-and-mouse-mice/

Ben Goldacre [AllTrials], Fiona Godlee [BMJ], and the Peter Gøtzsche [Nordic Cochrane Group] seem to be in a fairly intense cat and mouse game with Roche, GSK, and by proxy everything PHARMA over the meaning of the term data transparency. They mean “all of it” – the protocols, the raw data reports, everything the people doing the study have the opportunity to see themselves – including the data for studies not slated for publication – including the studies going back for thirty years. While it seems a bold request, the behavior of the pharmaceutical companies has been so regularly egregious that complete data transparency has moved from the level of a request to a requirement. At least in psychiatry, it would be unethical to practice just relying on the kind of information that has been available to us in the last several decades now that we know how far off the mark it has actually been – both in terms of efficacy and adverse effects, particularly the latter.

There is little question that these measures will negatively impact the profitability of pharmaceuticals, but those are clearly ill-gotten gains. The only rational alternative would be to dramatically tighten the FDA/EMA approval processes. And it seems a better solution for medicine itself to assertively assume the watchdog role. Medical ethics are neither the domain of pharmaceutical companies nor the government. That contract needs to be between physicians and patients. If we physicians are to be the gatekeepers and the dispensers of medications, then it’s our collective responsibility to do the checking so we know what we’re talking about. We can’t do that without access to those raw data sets.

On the other hand, no matter how well justified, the odds that the pharmaceutical industry will voluntarily agree to these conditions are about as good as those of that mouse on the right voluntarily walking out through the mouse-hole. The drug industry sees this campaign for Data Transparency as an invitation to commit suicide on Wall Street.

In psychiatry, there is a larger problem. Psychiatry has redefined itself over the last thirty years under the influence of the third party carriers, the pharmaceutical industry, and the body of organized and academic psychiatry to become clinical neuroscience [meaning psychopharmacology]. To further complexify things, the American Psychiatric Association is set to release its DSM-5 in May, a diagnostic manual created under the over-riding influence of the clinical neuroscience meme. So we have yet another cat and mouse scenario.

One might ask, “Who is the cat and who is the mouse?” Certainly the power base seems to be on the side of the pharmaceutical industry, the third party carriers, academic and organized psychiatry, and a still deluded populace who have been led to believe that these medications are more powerful and safer than they really are. Is this one of those times when a bunch of do-gooders can finally go against that kind of power and prevail? Sure. Look who’s on the run…
  1. Annonymous
    March 8, 2013 | 10:03 AM

    Let’s be clear, alltrials and Goldacre are explicitly NOT demanding patient-level stat access across the board.
    The new BMJ publication rule does speak to this, and it will be much much harder for researchers to deny access to patient level data when a problem is apparent from the clinical trial reports.
    I think alltrials needs to be backed wholeheartedly.
    But, I think it is important that it be clearly understood that alltrials is leaving out patient level data out of its main demand. Likely to start with a broad tent. And, to strip Pharma of its main counter-strategy.

  2. Annonymous
    March 8, 2013 | 10:11 AM

    There is also the question of whether or not the campaign’s longterm success depends on the awareness of clinicians in the US. 1BOM, how many of your compatriots have read the book?

  3. March 8, 2013 | 10:50 AM

    “Hear experts give oral evidence @commonsSTC about clinical trials next Wednesday 13th March http://www.parliament.uk/science/ #ALLTrials”

    My compatriots in Parliment have…

  4. Annonymous
    March 8, 2013 | 12:57 PM

    Those kind of compatriots will not show the ongoing vigilance needed to assure more than another set of “fake fixes.” We need a more fundamental understanding of the problem, and of the stakes, among physicians in order for 2013 to be different than 2008. If most of your fellow physicians have not heard of Goldacre’s book, much less read it, then that is a concerning state of affairs indeed.

  5. wiley
    March 8, 2013 | 6:46 PM

    I read about Dr. Drew and how his “patients” are killing themselves under his “tough love” approach to drug addiction that televises their withdrawal and profits from it, and I wondered whence the AMA? Can they not threaten this man’s licence for torturing his patients with Folk Psychology? He is not practicing medicine, he’s practicing the third-rate morality of an Elmer Gantry type huckster.

  6. berit bj
    March 9, 2013 | 9:06 AM

    BMJ has interviewed Andrew Witty, CEO of GSK, the British pharma giant recently fined 3 bn dollars in USA for criminal actions, off label promotion of dangerous drugs the most serious, most profitable, global sales around 10 bn pr year for the drugs in question.
    Witty looks his part, youngish, clean, a prince – fighting for the kingdom with weapons at his disposal. The power of charm, deception, money is set to postpone necessary changes for transparency, honesty, accountability as far into the future as politically possible.
    But governments footing the greater share of the pharma bill must – sooner or later – have to side with their populace – if democracy is to be their game. Tyrants come in unfamiliar guises, the pretty princes hard to unmask, a tale repeatedly told in the theaters of life, in private as in public.
    Nothing scared me more than having to realize our fundamental insecurity, always potentionally at the mercy of dark forces yet unseen, hiding in benevolent world figures, and in the doctor, nurse, MP, PM, CEO, father, brother, mother. Jaspers warned of the everpresent danger of fascism.

Remembering Seroxat Causing Self-harm (2004)


http://www.network54.com/Forum/281849/thread/1097319908/1097337553/%26quot%3Bless+than+a+small+class+size+would+have+these+suicidal+thoughts+or+attempts%26quot%3B

just 16 but within a week of starting seroxat had began self harming.

October 9 2004, 4:59 PM 

Sarah Thompson says she
self harmed on Seroxat

Sarah Thompson was prescribed Seroxat for depression three years ago. She was just 16 at the time.

She had never had suicidal thoughts before taking the drug, but within a week had began self harming.

She told the programme: “I’d never thought about suicide before I took Seroxat and when I was taking it. I was obsessed about death it was part of my every day life.

“I would cut myself mainly and then I started to burn myself and found other methods, but it was mainly cutting myself to start with.

Three years on, she has strong views about the regulation of the drug: “Looking back at what happened to me because of Seroxat, and the great affect it has had on my life and to my relationships with my family and my future.

“I don’t think that the regulators are doing their job properly, because they allowed me to take a drug that has in effect taken away part of my childhood.”