FOR ELI LILLY - YOU MUST BE SO PROUD OF YOURSELVES...

... as must your shareholders

GUILTY - JIMMY BARNES & JOE COCKER

I FOUGHT THE LAW - THE CLASH




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ELI LILLY PLEAD GUILTY!!!

Pharmaceutical criminals [because that's what they are] Eli Lilly, pleaded guilty to a 'misdemeanor' tied to the marketing of its top-seller, the anti-psychotic Zyprexa.

Lilly pleaded guilty to introducing misbranded drugs into interstate commerce. The company must pay a fine and forfeiture totaling $615 million.

Lilly agreed to the plea earlier this month and will pay about $800 million to resolve a civil case tied to the drug's marketing.

Prosecutors say Lilly sold Zyprexa to treat Alzheimer's-related dementia and depression, among other unapproved uses.

This from the Eli Lilly website:

Since its founding in 1876, Eli Lilly and Company has been rooted in a culture that values honesty, hard work, and caring for our community.

Nice to see that the term 'misdemeanors' now means honesty, hard work and caring for the community.

Fid

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Glaxo Takes $400 Million Legal Charge Over Marketing Probe

Source WSJ

GlaxoSmithKline is the latest drugmaker to pay the price for a government investigation of off-label marketing. The company said it’s taking a $400 million hit over a Justice Department investigation of the way Glaxo marketed top drugs.

Glaxo said it would take the charge in its fourth-quarter results due to an investigation initiated by the U.S. attorney’s office in Colorado over “marketing and promotional practices for several products” from 1997 to 2004. Glaxo reports earnings on Feb. 5.

Glaxo didn’t specify whether it was moving toward a settlement, but said its decision to take the charge “reflects the current status of the investigation, and is based upon the company’s most recent evaluation of the matter.”

According to Glaxo’s most recent annual report, the company received a subpeona from the Colorado U.S. attorney’s office in 2004 around promotion of nine of its top-selling products. The government inquired about alleged off-label marketing as well as medical education programs for doctors, “other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment.”

Though the subpeona came from Colorado, the inquiry is “nationwide,” the filing says.

Part of the investigation concerns a response the company provided to an FDA inquiry of alleged off-label promotion of antidepressant Wellbutrin SR.

Other drug companies paying up over Justice Department probes of off-label marketing include Pfizer, which just took a $2.3 billion charge linked to allegations around painkiller Bextra, and Eli Lilly, which settled for $1.42 billion over marketing of antipsychotic Zyprexa.

The Colorado U.S. attorney’s office declined to comment, and a Glaxo spokeswoman declined to offer additional details.

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GSK Controvosy

Source: Nation Master

Controversy

Paroxetine (Seroxat, Paxil) is an SSRI antidepressant released in 1992 by GlaxoSmithKline. In March 2004 the FDA ordered a black box warning placed on SSRI and other antidepressants, warning of the risk for potential suicidal thinking in children and adolescents. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens have sued GSK. On January 29 2007, the BBC in the UK broadcast a fourth documentary in its 'Panorama' series about Seroxat.[4] One clinical trial indicated that adolescents were six times more likely to become suicidal after taking it.

In November 2007, a United States Congressional committee released a report [5] describing intimidation of Dr John Buse (University of North Carolina at Chapel Hill[6][7]) by GlaxoSmithKline over his concerns about the cardiovascular risks associated with the company's antidiabetes drug Rosiglitazone (Avandia).[8]

In March 2006, California Attorney General Bill Lockyer announced that "GlaxoSmithKline (GSK) will pay $14 million to resolve allegations that state-government programs paid inflated prices for the firm’s anti-depressant drug Paxil because GSK engaged in patent fraud, antitrust violations and frivolous litigation to maintain a monopoly and block generic versions from entering the market."[9]

At the AGM on 19 May 2003, GSK shareholders rejected a motion regarding a £22 million pay and benefits package for CEO, JP Garnier. This was the first time such a rebellion by shareholders against a major British company has occurred, but was regarded as a possible turning point against other so-called "fat cat" deals within executive pay structure.

The company and its shareholders have been targeted by animal rights activists because it is a customer of the controversial animal-testing company, Huntingdon Life Sciences (HLS).[10] HLS has been the subject since 1999 of an international campaign by Stop Huntingdon Animal Cruelty (SHAC) and the Animal Liberation Front (ALF), ever since footage shot covertly by People for the Ethical Treatment of Animals (PETA), which was shown on British television, showed staff punching, kicking, screaming and laughing at the animals in their care. On September 7, 2005, the ALF detonated a bomb containing two litres of fuel and four pounds of explosives on the doorstop of the Buckinghamshire home of Paul Blackburn, GSK's corporate controller, causing minor damage.

In November 2005, AIDS Healthcare Foundation accused the company of boosting its short-term monopoly profit by not increasing production of the anti-AIDS drug AZT despite a surge in demand, hence creating a shortage that affected many AIDS patients in Africa. GSK announced that it had halted clinical trials of the CCR5 entry inhibitor, aplaviroc (GW873140), in HIV-infected, treatment-naive patients because of concerns about severe hepatotoxicity.[11] In June of 2006 GSK said it was further cutting, by about 30%, the not-for-profit prices it charges for some of these medicines in the world's poorest countries.[12]

Legal

In 2003 GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the antidepressant Paxil, and nasal-allergy spray Flonase. Later that year GSK also ran afoul of the Internal Revenue Service (IRS) and was facing a demand for $7.8 billion in backdated taxes and interest, the highest in IRS history. Medicaid is the US health insurance program for individuals and families with low incomes and resources. ...

On September 12, 2006 GSK settled the largest tax dispute in IRS history agreeing to pay $3.1 billion. At issue in the case were Zantac and the other Glaxo Group heritage products sold from 1989–2005. The case was about an area of taxation dealing with intracompany "transfer pricing" determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS. Taxes for large multi-divisional companies are paid to revenue authorities based on the profits reported in particular tax jurisdictions, so how profits were allocated among various legacy Glaxo divisions based on the functions they performed was central to the dispute in this case.[13]

In February 2007, the Serious Fraud Office in the UK launched an investigation into allegations of GSK being involved in the discredited oil-for-food sanctions regime in Iraq. They are accused of paying bribes to Saddam Hussein's regime.[14]

Paroxetine

On December 22, 2006, a US court decided in Hoorman, et al. v. SmithKline Beecham Corp that individuals who purchased Paxil(R) or Paxil CR(TM) (paroxetine) for a minor child may be eligible for benefits under a $63.8 million Proposed Settlement.[15] The lawsuit won the argument that GSK promoted Paxil(R) or Paxil CR(TM) for prescription to children and adolescents while withholding and concealing material information about the medication's safety and effectiveness for minors.

The lawsuit stemmed from a consumer advocate protest against Paroxetine manufacturer GSK. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens and thousands more worldwide – have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug's side effects and addictive properties.

According to the Paxil Protest website, http://www.paxilprotest.com/, hundreds more lawsuits have been filed against GSK.[16] The Paxil Protest website was launched August 8, 2005 to offer both information about the protest and information on Paxil previously unavailable to the public. Just three weeks after its launch, the site received more than a quarter of a million hits. The original Paxil Protest website was removed from the internet in 2006. It is understood that the action to take down the site was undertaken as part of a confidentiality agreement or 'gagging order' which the owner of the site entered into as part of a settlement of his action against GlaxoSmithKline. (However, in March 2007, the website Seroxat Secrets [1]discovered that an archive of Paxil Protest site [2] was still available on the internet via Archive.org)

Gagging orders are common in such cases and can extend to documents that defendants wish to remain hidden from the public. However in some cases, such documents can become public at a later date, such as those made public by Dr. Peter Breggin in February of 2006.[17]

In January 2007, according to the Seroxat Secrets website,[18] the national group litigation in the United Kingdom, on behalf of several hundred people who allege withdrawal reactions through their use of the drug Seroxat, against GlaxoSmithKline plc, moved a step closer to the High Court in London, with the confirmation that Public Funding had been reinstated following a decision by the Public Interest Appeal Panel. The issue at the heart of this particular action claims Seroxat is a defective drug in that it has a propensity to cause a withdrawal reaction. Hugh James Solicitors have confirmed this news.[19]

In March 2008 The Medicines and Healthcare Products Regulatory Agency concluded that GSK should have warned of the possible ill effects of taking Seroxat a lot sooner[20]. GSK could not be prosecuted under the old legislation, but the law has now been changed.

Ribena

On March 27, 2007, GSK pleaded guilty in an Auckland District Court to 15 charges relating to misleading conduct brought against them under the Fair Trading Act by New Zealand's Commerce Commission. The charges related to a popular blackcurrant fruit drink Ribena which the company had lead consumers to believe contained high levels of vitamin C. As part of a school science project, two 14-year-old school girls (Anna Devathasan and Jenny Suo) from Pakuranga College in Auckland (New Zealand) discovered that ready-to-drink juice sold in 100ml containers contained very little vitamin C. Approaches by the two teens to the company didn't resolve the issue but after the matter was publicised on a national consumer affairs television show (Fair Go) the matter came to the attention of the Commerce Commission (a government funded 'consumer watch-dog'). The commission's testing found that ready-to-drink Ribena contained no detectable vitamin C.

The company was fined $217,000 for the 15 charges. The number of charges was reduced from 88 and covered a period from March 2002 to March 2006.

GSK maintains that it did not intend to mislead consumers and that the advertising claims were based on testing procedures that have since been changed. It was ordered to run an advertising campaign to provide the facts after it admitted misleading the public about the vitamin C component in its Ribena drink. Through its lawyer, Adam Ross, the company accepted Commerce Commission allegations that claims that ready-to-drink Ribena contained 7mg of vitamin C per 100ml, or 44 per cent of the recommended daily intake, were incorrect. The company also agreed television advertising claiming the blackcurrants in Ribena had four times the vitamin C of oranges, while literally true, were likely to mislead consumers about the relative levels of vitamin C in Ribena.[21]

*Hat Tip - The Truthman

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Study: Zoloft and Cipralex better than other drugs

Source: Forbes.Com


Doctors have long assumed that most antidepressants are interchangeable.

But according to a new study, Zoloft and Cipralex work slightly better than 10 other popular drugs, and should be psychiatrists' first choice for patients with moderate to severe depression.

Previous research found few differences between antidepressants. A U.S. government study in 2006 concluded that patients with major depression did equally well on different drugs.

But in a paper published online Thursday in the Lancet medical journal, two antidepressants came out on top, though only marginally.

International doctors examined more than 100 previous studies on a dozen antidepressants, which included nearly 26,000 patients from 1991 to 2007.

They found that Zoloft, developed by Pfizer Inc. and Cipralex, developed by Forest Laboratories in the U.S. and Danish drugmaker H. Lundbeck A/S in Europe, were the best options when considering benefits, side effects, and cost. In contrast, Pfizer's Edronax was the least effective.

All three drugs are now available generically.

The other drugs tested were Celexa, Cymbalta, Efexor, Ixel, Luvox, Prozac, Seroxat, Remeron, and Zyban

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PM Gordon Brown in bed with Pharma

Never mind great British institutions such as Woolworth or the ever dilapidated car industry. Forget Barratts shoe shops and Adams baby clothes. PM Gordon Brown gets his priorities in order by summoning senior industry figures, such as Andrew Witty, chief executive of GlaxoSmithKline, and David Brennan, his opposite number at AstraZeneca, to a meeting at No 10 to discuss ways of protecting pharmaceuticals and biotechnology companies, their revenues and their jobs.

Amazing isn't it?

Further evidence that this government is in bed with pharma.

Money talks folks.

Full story here

Fid

Hat-Tip - Steph Gatchell

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Danger: High Voltage Down Under

CHILDREN younger than four who are considered mentally disturbed are being treated with controversial electric shock treatment writes the Herald Sun in Australia.







The article cites that:

About 12,000 treatments were performed in the public health system last financial year.

Medicare statistics record 203 ECT treatments on children younger than 14 - including 55 aged four and younger.

Two of the under-4s were in Victoria.

Last financial year, 6,197 ECT treatments were given to Victorians against their will.

This on the back of a report from The Age in 2006 when it was reported that child psychiatrist, Selwyn Leeks, agreed to stop practising ECT after patients came forward and claimed they were punished for minor breaches of discipline by electroconvulsive therapy, administered by Dr Leeks.

Child shock therapy story here

Selwyn Leeks story here

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Obama battles big pharma

Tuesday, 27 January 2009

Source: The Independent

"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.

For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.

Full [hopeful] story here

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Phil Dawdy: "...emblematic pajama journalist"

Shout out to Furious Seasons author, Phil Dawdy.

If there is one journo that deserves praise for uncovering the truth, my vote goes to Phil Dawdy of Furious Seasons.

Sure, there are some excellent journo's out there, Bass, Pringle and Silverman to name but a few. But whereas the aforementioned receive acclaim through various media outlets, Dawdy plods along writing on the excellent and informative website, Furious Seasons.

His hard work, it seems, is paying off at last.

Author and journalist David Dobbs recently wrote an article on the reporting of Zyprexa by the mainstream press and, what he terms, the 'pajama press'.

He refers to The Times breaking the the uncovering of Lilly's off-label marketing of Zyprexa, for which Lilly last week agreed to pay a $1.42 billion fine. He wrote: "Such source access comes far more readily to an institution like the Times. The lawyer gives the documents to the Times because the Times can make a splash big enough to risk the leak. The Times stayed on the story, creating tremendous pressure, and so did several other papers."

Dobbs then [rightly] praises Dawdy for his work on the above case. He writes:

"However, unique and critical contributions came also from another front -- the blogger Philip Dawdy, who at Furious Seasons has reported and written extensively on Lilly's illegal marketing of this powerful antipsychotic. Dawdy, an independent one-man op working with low pay, no benefits, and minimal infrastructure, is an emblematic pajama journalist. A former journalist (he got laid off), he's open about his interest rising from his experience as someone formerly treated for bipolar disorder with antipsychotic medication. (He's off now, and seems to manage pretty well.) Though he's often accused of being antipsychiatry, he's not. He just feels, like many both outside and inside psychiatrty, that conflicts of interest within the field and hypermarketing on pharma's part have harmed both patients and the discipline. He works hard to practice an impassioned but disciplined type of journalism."

He continues with:

"Dawdy has pressed the Zyprexa story hard since early 2006 -- it's possible no one has read or written more about it -- adding, synthesizing, and commenting on tons of information, and he pulled the sheets off in February 2007 by publishing, at what would seem to be frightening legal risk, the full set of court documents relating to Lilly's Zyprexa marketing. Presumably these are the same documents that were sent to the Times a couple months earlier, but which were not easily obtainable publicly until Dawdy posted them.

How do you compare the contributions here? You can't get the scale to hold still. Yet it's clear that the combination of the Times expose and Dawdy's reporting and outing of the documents created a dual pressure that was crucial to the growing attention the case received, and ultimately to Lilly's extraordinary admission last week of criminal activity."

Slowly but surely great writers are being acknowledged for great work. Dawdy is no exception.

Phil [Dawdy] has become a friend over the years I have known him, so much so that he even went out and purchased a copy of AC/DC's Black Ice after reading about my passion for AC/DC on this blog.

It was Phil who gave me the 'Bruce Lee Award' for 'kicking ass' on his website sometime last year, a website that was featured in the MHRA's paper regarding the influence of bloggers.

Like a lot of us, Phil has faced some tough times health wise and financially. These are everyday obstacles that we all seem to come through [eventually]. Here we have a writer creating awareness about the underhand dealings of psychiatry and pharma, he does this without payment, he does this not knowing if he can afford to meet the payments of his fuel bills or rent at the end of the month.

It takes balls to keep going when everything seems to be going against you, particularly when your fight is against the money making machine that is pharma.

Phil is one of those who has stood up to be counted, he has done it right in the face of adversity. Our lives are pretty much parallel in as much as both Phil and I bang the drum loudly to guide people to the truth. Like me, Phil has his own Internet stalker, like me, Phil struggles financially. Like me, Phil Dawdy has a great passion for seeking the truth and for spreading that truth as far as he possibly can.

Phil deserves the credit from Dobbs, he deserves all the accolades coming to him. The guy should not be left on the heap to rot. There aren't many bloggers who break news stories the way Phil does. Investigative journalists are a rare breed and in Phil Dawdy we have someone keeping the pressure on the corrupt pharma industry and their collusion with psychiatry.

Your time has come buddy. Karma is knocking on your door.

The Bruce Lee Award is heading back to you.

Light one up for me.

Fid

Hat tip - Susan


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Glaxo Whistleblowers step up to the 'lucrative' plate

Whistle-blower’s perspective on Lilly case
By Miriam Hill

INQUIRER STAFF WRITER

Robert Rudolph knew he was about to end his lucrative career at Eli Lilly & Co., but he had to say something.

Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?

Why had the company violated privacy rules by culling patient lists at doctors' offices?

Why was the company counting drug samples as sales, which would boost the stock price?

He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.

"I'd just been wrestling with this stuff for so long," he said in a telephone interview today. "I was put in a position of breaking the law, in my view, or quitting."

Rudolph and eight other whistle-blowers brought their allegations to federal prosecutors. That led Lilly to agree Thursday to a record $1.4 billion fine to settle charges of marketing Zyprexa illegally.

Zyprexa had been approved by the Food and Drug Administration for schizophrenia and bipolar disorder - but in 2001, the company began promoting it for other uses, such as treating anxiety, agitation and confusion in the elderly.

Drug companies are permitted to market drugs only for approved uses, though doctors may prescribe as they see fit. Lilly did an end run around the process by telling doctors Zyprexa could ease agitation, anxiety, and other everyday symptoms, according to the Philadelphia U.S. Attorney's Office, which brought the case.

In a statement today, Lilly insisted its employees always adhered to strict ethics. "Doing things the right way at Lilly is more important than securing a prescription," the statement said.

Rudolph and several other whistle-blowers found their way to prosecutors through their attorneys, Steve Sheller of Sheller P.C. and Michael Mustokoff of Duane Morris L.L.P., both of Philadelphia, and Gary Farmer of Florida.

Lilly's Zyprexa marketing material included pictures of composite patients such as Martha, a confused and agitated widow.

"If you looked at it, you would say this was an Alzheimer's dementia patient," Rudolph said in the interview from his home in Oregon.

Other tactics bothered him, too. Company employees were allowed into doctors' offices on weekends to collect names of patients taking certain drugs in hopes of switching them to Lilly products.

"We're not selling soap. We're selling chemicals that can be dangerous if they're not used in the right way," he said.

That was especially true of Zyprexa, which caused weight gain. And diabetes is a risk of the drug.

Rudolph, who was a pharmacist before joining Lilly in 1976, chose the company because of its sterling reputation.

But gradually, as financial markets boomed and stock options became a bigger part of executive pay, Lilly's culture began to change, Rudolph said.

Instead of the pharmacists it had traditionally hired, Lilly started bringing in recent college graduates who had no medical background and were easy to train to parrot the company line. Instead of a profit-sharing program that all employees participated in - "even the guy who swept the floor," Rudolph said - compensation shifted to rewards-based on sales.

"This new way of compensation kind of opened the door for a lot of unscrupulous practices, I felt," Rudolph said.

He warned management of his concerns. Their response: "You're not a team player."

He began talking to other sales representatives about the issue, including Hector Rosado, another whistle-blower in the case.

As he pondered what to do, Rudolph's son, then 15, provided a moment of clarity:

"He came up to me and said, 'Dad, what's wrong is wrong.' I had taught my kids that. It was wrong, and I wanted to make it right."

So he raised his hand at the Lilly district sales meeting in Sacramento, Calif., in January 2002.

The stress of the job had thrown him into a depression. Managers made it clear they wanted him to leave, so six months after he made his stand at the meeting, he retired from his $115,000-a-year job.

He and the eight other whistle-blowers will split $78 million to $100 million of the settlement. Rudolph, 60, says the settlement against Lilly will only go so far in changing business practices. He wants jail time for wrongdoing by companies and executives.

Zyprexa sales were about $39 billion since FDA approval in 1996. Lilly did plead to a single misdemeanor of misbranding of a drug.

"You have to remember, with Zyprexa," he said, "people lost their lives."

----

**Lilly will pay $800 million in civil penalties and plead guilty to criminal charges, paying an additional $600 million fine. The six whistleblowers who brought the Complaint against the drug company will share in approximately 18 percent of the federal and qualifying states' recoveries.

Quite a carrot to dangle for any whistleblower!

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PFIZER & MHRA AIR AD IN CINEMAS

It's a pretty shocking ad, once again it gets the message across.

It shows a man opening a package which contains a packet of pills, he opens the pills, swallows one then seconds later is seen pulling a dead rat from his mouth.

The voice over then states: "Rat poison, just one of the dangerous ingredients that may be found in fake medicines purchased from illegal websites."

The message, 'GET REAL, GET A PRESCRIPTION' is then shown along with the website, http://www.realdanger.co.uk/

Real danger.co.uk is brought to you by Pfizer.

Now, I'm all for stamping out fake drugs but I find it quite strange that both the MHRA and Pfizer would use rat poison as a shock tactic particularly as rat poison [sodium borate] is used in the HPV Vaccine:

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, and water for injection. The product does not contain preservative or antibiotics.

There is no advertising campaign to warn of the dangers of the current HPV Vaccine.

I wonder why?

Maybe the MHRA should GET REAL, LISTEN TO PATIENTS

Fid

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SSRI chemical imbalance theory

The following is an extract taken from a featured article called 'The Media and the Chemical Imbalance Theory of Depression' by Jonathan Leo & Jeffrey R. Lacasse.

Abstract

The cause of mental disorders such as depression remains unknown. However, the idea that neurotransmitter imbalances cause depression is vigorously promoted by pharmaceutical companies and the psychiatric profession at large. We examine media reports referring to this chemical imbalance theory and ask reporters for evidence supporting their claims. We then report and critique the scientific papers and other confirming evidence offered in response to our questions. Responses were received from multiple sources, including practicing psychiatrists, clients, and a major pharmaceutical company. The evidence offered was not compelling, and several of the cited sources flatly stated that the proposed theory of serotonin imbalance was known to be incorrect. The media can play a positive role in mental health reporting by ensuring that the information reported is congruent with the peer-reviewed scientific literature.

Before you read the full article, take a look at the following:

Lexapro - Manufacturer - H. Lundbeck A/S - Denmark – (Forest Laboratories in the US) - "Lexapro corrects this chemical imbalance andmay help relieve the symptoms of depression" [Patient Information Leaflet]

Cipramil / Marketed under the Brand Name Celexa in the US - Manufacturer - H. Lundbeck / American partner Forest Laboratories: Google search "Celexa helps to restore the brain’s chemical balance by increasing the supply of a chemical messenger in the brain called serotonin."

Pristiq - Manufacturers - Wyeth: "As an SNRI, PRISTIQ affects the levels of two neurotransmitters thought to play a key role in depression — serotonin and norepinephrine. Serotonin and norepinephrine are chemicals that occur naturally in the brain. While no one knows for sure what causes depression, many experts believe that it may occur when neurotransmitters are out of balance." Pristiq website

Aropax [Seroxat] - Manufacturer - GlaxoSmithKline: "Aropax corrects the chemical imbalance and so helps relieve the symptoms of depression." GSK Australia

Geodon - Manufacturer - Pfizer: "How GEODON Works. Doctors believe GEODON helps balance certain natural chemicals in your brain. Balancing these chemicals helps treat your symptoms of acute manic or mixed episodes associated with bipolar disorder. And that can help you feel better." - Geodon Website

There are many more. Now read the article

Fid

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An Interview with Joanna Moncrieff: The Myth of the Chemical Cure

Thanks to one of my readers, Ruth, for passing this on to me.

It's an interview with Joanna Moncrieff, author of the book, 'The Myth of the Chemical Cure: A Critique of Psychiatric Drug Treatment'

I shall re-publish the entire interview here for you all to read. The original page can be found here.

----

In this interview she responds to questions about this so – called "chemical imbalance" and the treatment of depression.

1) Dr. Moncrieff, first of all, what led you to write this about about "the myth of the chemical cure"?

What is written in textbooks about psychiatric drugs and how they work never seemed to match up to reality to me. So I started to look carefully at the research on drugs and gradually I came to realise that there was no evidence that they were acting specifically- that they were reversing the basis of a disease- as it was claimed. At the same time I was interested in how drugs came to be so highly regarded in psychiatry- how they came to be the dominant form of treatment. I realised that it was because they were believed to be specific that they were seen as so important, because the idea that they are specific underpins the idea that psychiatry is a medical activity, concerned with reversing medical diseases.

So I began to try and trace how the idea- the myth as I believed it - that they are specific treatments was constructed.

2) I would think that when people have to deal with the death of a mother/father, brother/sister, or even a pet, I think that it is natural and normal to feel depressed. When did we start giving anti-depressant medication for the normal transitions of life that we all have to endure?

The modern concept of depression, as a common condition in need of medical treatment, was invented and promoted in order to market the earliest antidepressants in the 1960s. However, it was when the market for benzodiazepines collapsed in the late 1990s that the pharmaceutical industry turned to depression to create a mass market.

It was during the 1990s that the idea that depression affects up to 1 in 4 of the population and other such figures were publicised and the motive was to create a market for the new and profitable antidepressants known as SSRIs.

3) How exactly do psychiatrists find out if there is a real chemical imbalance in the brain? Or are they just experimenting with patients?

Psychiatrists have no way of telling that someone has a chemical imbalance. The idea that depression is caused by a chemical imbalance is simply a hypothesis. There is no consistent evidence that there is any biochemical abnormality in people diagnosed as depressed. The idea has been promoted by drug companies and professional organisations, but the evidence base for it is almost non existent. Most experts say that the fact that people improve when you give them antidepressants is the strongest evidence that there is a chemical imbalance. But there are other ways of explaining this- antidepressants are psychoactive drugs, that may suppress emotional feelings, or just sedate people.

Anyway, as recent research shows, people improve barely more with antidepressant than they do with a placebo.

4) The number of pills for a wide variety of so- called " mental illnesses " seems to have skyrocketed. Someone is making a lot of money pushing these pills. Is it all about money?

Partly, but it is also about professional status. Psychiatrists push pills because it bolsters their position as doctors. Also governments have supported medical interventions like drugs because they look like simple solutions to otherwise complex and intractable problems. Also we live at a time when big business is very powerful, and governments are unwilling to reign it in.

5) I know there are some violent, aggressive, assaultive patients who either have to be physically restrained, or put in a special room, or a straight jacket. In such instances, are we simply sedating the patient or are we really treating them?

I think everyone would admit that at times like these we are simply sedating them, or using chemical restraint. What is more open to dispute is what we are doing to people whose behaviour is chronically antisocial, disturbing and maybe irrational. People like this are usually diagnosed as having chronic schizophrenia, or some other mental disorder. In this case, the drug treatment they are inevitably given on a long-term basis is dressed up as a treatment, but is often aimed at controlling their behaviour.

6) Are there germs, bacteria, viruses, and things that can be seen under a microscope that cause "mental illness"?

No- there are no proven physical causes of any mental illnesses.

7) We all have to deal with anxiety- we have to work, take tests, deal with disgruntled people- why do some people need anti-anxiety pills for the problems that we all have to face---and do these folks have some type of chemical imbalance?

Everyone is different and some people find stress harder to deal with than others.

This is partly due to upbringing and environment, but some of it is probably due to the variation in our biological makeup. However, I don't think it is something you can pinpoint, like a chemical imbalance.

It's just that we are all different, biologically as well as psychologically. You can't "correct" these differences (assuming you could identify them, which I don't think you will ever be able to do) without eradicating individuality itself.

8) Is there really such a disease as attention deficit disorder or is this just a bunch of symptoms that have been lumped together in some fashion?

Its not my specialist area, but child psychiatrists I know say that they can always find a better explanation for a child's behaviour than calling it ADHD. ADHD is a label that locates the problem in the individual child, whereas I suspect the problem really often lies in the family and the wider environment. The only reason for giving someone the label of ADHD, of course, is in order to justify giving the child stimulants. There is a big debate about whether these are useful- and if so whether they are worthwhile. They can make a child pay attention at first, but whether this is really beneficial is unclear. Also their effects probably wear off (like most drugs taken for long periods)- and the latest 3 year follow up of the biggest randomized trial of stimulants shows no benefits over non drug treatment at three years.

9) I have read some crazy stuff on the Internet about statins being given to 8 year old children. Is there any sane, reasonable, rational, realistic reason to give an 8 year old child a statin?

I don't know about the wisdom of giving children statins, but childhood obesity (not a nice word) is certainly an indication that there is something very wrong with our society. It is also caused of course by drugs like the new antipsychotics, which are being more commonly prescribed to children. So some childhood obesity is being caused by drugs in the first place.


10) Here in the United States, we once had a commercial that said " relief is just a swallow away". Have the pharmaceuticals taken this mass drugging way too far?

Everyone is looking for a magic bullet for everything nowadays. The pharmaceutical industry have certainly helped create this situation, but again I think it is the broader political climate that has encouraged this to happen. Popping pills to solve your problems is a perfect consumerist activity, and it helps keep people so worried that they don't have time to challenge the system. Accepting life's ups and downs is not a good recipe for keeping people working their guts out to buy more stuff.

11) I often see individuals who seem to have no coping skills, low frustration tolerance and a lack of thinking skills. Should not these people get training and counseling, rather than some pill for their alleged " chemical disorder"?

Yes, these would be better, but often there is no individual solution. We have to ask why some people get this way, and what changes we can make to society to prevent it happening and to help them when it does.

12) Are there any psychiatric diagnosis which in your mind, are true "chemical imbalances" for example chronic schizophrenia?

No. Organic conditions like dementia and learning disability have a physical basis (but not a simple chemical imbalance). For mental illnesses like schizophrenia, manic depression and others, no physical cause has ever been proven. It is often said that we have evidence that they are genetic- but this evidence is much weaker than presented (Jay Joseph gives a good deconstruction of this). It is said that people with schizophrenia have different shaped brains- but again the evidence is weak and inconsistent and drug induced effects have not been ruled out.

13) Do you have a web site where we can get more information?

The Critical Psychiatry Network has a website where there are many interesting papers posted and other information. The address is www.criticalpsychiatry.co.uk

14) What question have I neglected to ask?

Whatever mental illnesses consist of, and we do not know, but have no good evidence at present to think they are caused by specific brain diseases like real neurological conditions, when we treat them with drugs we are merely drugging people. This may suppress the symptoms, which may be helpful for a while, but obviously there are adverse consequences. If you are drugged you are usually slower and less emotionally sensitive than if you are not under the influence of drugs. Psychiatrists need to be more honest about this- but so do politicians and society as a whole. We are pretending to treat or cure people with mental illness because that makes us feel alright about controlling them. Sometimes we need to control them but we should at least be honest about what we are doing. Pharmaceutical companies are cashing in on our dishonesty.

Published August 7, 2008

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New song about SSRi's

I'm not really into the rap genre but this song is pure quality.

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Pfizer team up with the Medicines and Healthcare Products Regulatory Agency

Well, it's been a while since I had a pop at the MHRA. They gave me my meeting in September last year and as I understand 'wheels are in motion' as a result of that meeting.

However...

News just in that the MHRA have teamed up with Pharma giants, Pfizer, in a bid to stop men from buying prescription medicine over the Internet. Although the article does not state exactly what drug they are referring to one can hazard a guess that it is Viagra.

And who, might you ask, is the leading manufacturer for Viagra?

You got it... PFIZER!!!

Mick Deats, group manager of enforcement at the MHRA said: "The MHRA will not hesitate to take action against those who undermine public health."

Just like they took action against GlaxoSmithKline for hiding data that undermined public health. What was it now? Ah, yes... they sent GSK Chief Garnier a warning letter.

What next for the MHRA?

Will they team up with GlaxoSmithKline in an attempt to stamp out St John's Wort?

Maybe they would like to team up with a whole bunch of people that are addicted to their SSRi medication or team up with family members who have lost loved ones as a result of SSRi medication?

I'm all for better regulation of medicines, Christ knows I've been banging the drum loudly enough for nearly three years - I got a meeting - Pfizer get an advertisement campaign with the help of the regulators!

The advertisement is basically telling men not to buy erection pills online, I'm sure the MHRA will argue that there are a range of medicines online but we've all had the 'PENIS EXTENSION' emails hit our spam filters haven't we?

Good old Pfizer no doubt stumped up a huge part of the money for this campaign, a campaign that will no doubt bring them financial reward as 'punters' turn to their product.

What a disgrace. What a collusion. What a massive conflict of interest!

Fid

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GLAXOSMITHKLINE'S 'SHOCKING' VAGINA AD

Whilst I agree that the ad gets to the point, I find it distasteful to say the least.

Here is GlaxoSmithKline's new TV campaign in the Netherlands for their product, Lactacyd Femina.

From the Glaxo site:

"Lactacyd Femina is a range of feminine intimate care products which not only cleanse, but also help protect against sources of irritation."

Now watch the advertisement!

Fid

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Glaxo's Secret Emails - This time Avandia

Most of us are aware of Glaxo's secret emails regarding Seroxat. Basically, GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. They are still trying, it seems, to gain a licence in Japan.

Earlier this week news broke of yet another collection of secret emails, this time concerning the drug, Avandia.

In 2007, a Cleveland Clinic study conducted by prominent cardiologist Dr. Steven Nissen and published in the New England Journal of Medicine (NEJM) found that patients taking the diabetes drug experienced a 43-percent higher risk of suffering a heart attack. At that point GlaxoSmithKline argued against the findings.

According to the Wall Street Journal, the Glaxo emails prove its own researchers were worried its findings echoed that of Nissen’s. Glaxo’s senior consultant wrote in an email, “The numbers are the numbers, the analysis is very similar to our own.” He added that Glaxo couldn't "undermine" the figures but might find a way to explain them.

Sen. Chuck Grassley of Iowa, has been pushing the FDA to ask Glaxo to withdraw Avandia. He is apparently preparing a report that may be released soon containing excerpts from Glaxo documents about the company's efforts to defend its drug from the New England Journal study.

Steven Haffner of the University of Texas had already agreed to read it as part of the peer-review process for the New England Journal of Medicine but later went on to tell Glaxo of the 'confidential' paper before it was actually published. Haffner had been a Glaxo consultant on Avandia since 2000 and received $433,000 from Glaxo between 2000 and August 2007. Remarkable loyalty to his paymasters!

Nissen was paid a visit top Glaxo scientists, including the chief medical officer, just days before publication, they tried to get him to rethink his concerns. "They never revealed that they had obtained a copy of our manuscript and had concluded that our findings were irrefutable," he says. "Instead, they attacked the validity of the study and the motives of both the authors and the NEJM."

The Wall Street Journal hasn't yet viewed the full emails but one excerpt shows:

"There is no statistical reason for disregarding the [Nissen] findings as presented."

Why did Haffner show GlaxoSmithKline? Well, in his own words:

“Why I sent it is a mystery”

“I don’t really understand it. I wasn’t feeling well. It was bad judgment."

GlaxoSmithKline, as you would expect, have played it all down with some wonderful spin.

Nancy Pekarek, of GlaxoSmithKline, said:

Dr. Haffner had sent the article to the company on May 3, more than two weeks before the article was published in the New England Journal. He expressed concerns and questions regarding the methodology of the analysis, and sent the article to GSK for advice from experienced statisticians.

She added “We believe GSK acted appropriately and responsibly in responding to the situation.”

Here's what Alistair Benbow said when Glaxo were found to have withheld information on safety concerns for Seroxat:

""We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme..."

I'll leave it up to the readers of this blog to draw their own comparisons.

Fid

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Glaxo - Turning Japanese!

Read more here & here

Fid

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Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Dear Sir/Madam,

May I bring to your utmost attention an undergoing recruiting campaign by pharmaceutical giants, GlaxoSmithKline, in your country.

GSK Japan are recruiting children from the ages of 7 to 17 "To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents..."

This is surprising as by GSK's own admission they have already stated that "Paroxetine is not approved for the treatment of patients younger than 18 years of age." - http://www.gsk.com/media/paroxetine.htm

One has to beg the question why they are recruiting in Japan to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) - http://clinicaltrials.gov/ct2/show/NCT00812812?intr=paroxetine&rank=2&flds=Xabcg

As far as I am aware, Japanese human beings aged 7 to 17 have the same make-up as human beings of that age range from the UK, USA etc.

A few news stories regarding paroxetine, GSK and efficacy in children may broaden your mind. These can be found here:

BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil) - http://www.newsinferno.com/archives/1409

MHRA Investigation into Glaxosmithkline/ Seroxat 6 March 2008 - http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON014155&RevisionSelectionMethod=LatestReleased

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolecents - http://www.healthyskepticism.org/documents/PaxilStudy329.php

----

I would be grateful if you could acknowledge receipt of this email and tell me of your intentions.

Thank you for reading.

Yours sincerely

Bob Fiddaman

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Concerned Canadian Citizen [Email to Health Canada]

I've just been copied in on an email sent to Health Canada from a very concerned Canadian citizen. They have given me permission to post the email on my blog. The person's name and email address have been redacted at their request:

Dear Health Canada,

It is very obvious that Paxil poses a serious threat to the life and liberty of children and adults in Canada. It seems equally as obvious that there is an overprescribing issue. Tonight I found a website created by GlaxoSmithKline. The sites intended purpose is pre-screening for shyness which they feel their drug is suited well for. I find that extremely difficult to believe. (Both the fact that shyness is a mental illness at all and that the benefits of Paxil would outweigh any risk)


I'm not going to sit here and try to convince you of Paxil's mounting death toll and the 16 yr wake of needless suffering. I know you know about it so let's not debate the obvious.


I did some research on the side effects of other known disasters you have pulled from the shelves such as Vioxx and Thalidomide. I am wondering why, in spite of the fact that SSRI drugs have a much higher number of reported severe side effects than either drug mentioned above; you have done very little about it.

I would suggest Paxil be removed from the shelves but someone is making far too much money for that request to be realistic.


1) When you are going to demand GlaxoSmithKline to make their warning labels more visible? I have seen the warning label and it does not stand out at all which was also reported on the evening news which focused on the senseless death of Sara Carlin and Ontario Chief Corners office. I don't think that this is an unreasonable request especially considering a more visible label could have saved some of the Canadian lives we have already lost and will save some in the future which should be Health Canada's main focus.

2) When can the public (Paxil addicts) expect a withdrawal program?

You, along with doctors have been made aware of how difficult it is to withdraw from Paxil. Leading experts suggest greater than 40% of users will experience severe withdrawal complications. This is hardly a number to ignore. I am also wondering how many people have been forced into poverty and live off of disability as a result of this health care disaster that is out of control and has been for many years.

After corresponding with world experts on SSRI withdrawal it is my understanding there is no withdrawal program in place and that you have never requested one in spite of how debilitating withdrawal can be and the threat to one's life. GlaxoSmithKline suggests a two week tapering period. Experts like Dr. David Healy have regarded this as nearly an impossible challenge for patients and a very dangerous one at that. After being prescribed Paxil for PMDD (bad PMS) and spending two years getting off these drugs, I can assure you that the experts are not exaggerating. I don't know how I survived it. A child with an uninformed doctor and ignorant parent or caregiver does not stand a chance. Don't reply to me and tell me that Paxil is not licensed for children. It is being prescribed off label every single day for children and we both know it.

Considering the number of people taking SSRI drugs I feel strongly that these issues should have been addressed carefully long before now. It seems to me that Health Canada has demanded the bare minimum from a company guilty of tax evasion and collusion in the United States, Half a billion dollars worth of bribery in Italy, Illegal drug trials in New Jersey, ghost writing, and faced criminal charges for knowingly promoting a drug proven ineffective and extremely dangerous in children. I'm sure I have missed a few but surely you get my point. With the latter in mind it has come as a shock to me and other consumer advocate groups that GSK is planning on a second attempt at a pediatric license in Japan.

If I were to pull any one of those stunts would you continue to do business with me and bend the rules in my favor or would I be behind bars? If I were your neighbor would you trust me to watch your child?

Of course you would not trust me with your child. But you have been telling Canadians to trust GSK with their children knowing the company is promoting an unsafe drug for our most vulnerable members of society and the very people that will be running this country one day.

GlaxoSmithKline has been selling life saving drugs for a very long time. However, this does not give them a license to intentionally deceive Health Canada, Canadian doctors and consumers.

It has always been your job to protect and defend the health and safety of Canadians. I feel that in regard to Paxil, you have failed us.

I would really like a reply to this but not a cut a paste of a standard reply. I intend to report on this as it will be the focus of a paper I have been working on.

Regards,

Name redacted

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Mental Health Screening, Psychiatry & Pharma Marketing Scam

Fid

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GSK Target Teenagers?

GSK Target Teenagers?

How I think GSK's online Social Anxiety Disorder [SAD] Test targets teenagers.

Let's go through GSK's SAD Test [Remember the SAD Test is online, the website has pictures of Paxil plastered all over it]


1. Are you afraid of people in authority. "Adolescents are extremely reluctant to confide in adults or authority figures. Many teens fear their concerns about relationships will be ignored, belittled, or ridiculed because adults tend to underestimate the intensity of adolescent relationships." 1

2. Are you bothered by blushing in front of people. "Statistically, teenagers blush more often than adults." 2

3. Parties and social events scare you. "By labeling shyness and other human traits as mental conditions with a biological cause, the doors were opened wide to a pharmaceutical industry ready to provide a pill for every alleged chemical imbalance or biological problem." 3

4. Do you avoid talking to people you don't know. See 3

5. Being criticized scares you a lot. "The better teenagers feel about themselves, the higher their self-esteem and ability to cope with these temporary problems." 4

6. Fear of embarrassment causes you to avoid doing things or speaking to people. See 3

7. Sweating in front of people causes you distress. "Research shows that 48 percent of teens sometimes think that their sweating is a problem." 5

8. You avoid going to parties. See 3

9. You avoid activities in which you are the center of attention. See 3

10. Talking to strangers scares you. See 3

11.You avoid having to give speeches. See 3

12. You would do anything to avoid being criticized. See 4

13. Heart palpitations bother you when you are around people. "Fear is a habit, and it is developed within you just as other habits are." 6

14. You are afraid of doing things when people might be watching. See 6

15. Being embarrassed or looking foolish are among your worst fears. See 6

16. You avoid speaking to anyone in authority. See 1

17. Trembling or shaking in front of others is distressing to you. See 6

This 'test' does nothing but play on human emotions and it plays on the mind of teenagers who are at an age where their bodies are changing. We have all been through it, we have all dealt with it in our own ways. Shyness is a natural human emotion. It does not need pills to cure it as it is not an illness.

The test is a brilliant marketing tool. Give a teenager a spot [acne] overnight and they wake in the morning, frantically searching for the spot cream, if they can't hide the spot, they may squeeze it until the pus shoots out onto the bathroom mirror, often making the spot look worse. It is something they don't want, something they wish to hide. Same goes for shyness. Nobody wants to be put into situations they don't want to be in. Even as adults we fret at night, tossing and turning in bed because we have that important interview in the morning, because the good looking girl/guy will be working alongside you and you just don't know what to say.

It's a human emotion that we were all born with. It rears its head when we are teenagers, when we think we know it all.

I'd go so far to say that if we didn't feel shyness then that would be some form of illness. Alas that is not profitable for pharmaceutical companies such as GlaxoSmithKline. There are far more shy people than there are people who are not shy.

And what exactly is shyness? Wikipedia defines it as: "In humans, shyness (also called diffidence) is a social psychology term used to describe the feeling of apprehension, lack of confidence, or awkwardness experienced when a person is in proximity to, approaching, or being approached by other people, especially in new situations or with unfamiliar people."

I'm guessing here but my money is on the fact that every single one of us have experienced feelings of apprehension, a lack of confidence, a feeling of awkwardness etc.

As we have grown older we have learned to deal with our fears. Cast your minds back to when you was a teenager experiencing the above. It was all new to us wasn't it?

It's part of life, a life, it seems, that Pharma want to take control of because it will make them a huge amount of money.

The online test carries the disclaimer "This site is intended for US residents only, 18 years and older." But it's plainly obvious, to me at least, that this test is aimed at teenagers who are experiencing life as it is, how it will always be.

Fid


1. Teenagers - http://www.yakimacounty.us/PA/DomVio/Teens.pdf

2. Why Do Some People Blush? - http://www.wisegeek.com/why-do-some-people-blush.htm

3. How shyness and other normal human traits became sickness - http://www.physorg.com/news111222013.html

4. Common teenage problems - http://www.bbc.co.uk/parenting/your_kids/teen_problems.shtml

5. Sweat Solutions - http://www.sweatsolutions.org/SweatSolutions/Article.asp?ArticleCode=60713936&EditionCode=88906227

6. Mastering Your Mind Power - Recognize How Fear Controls You - http://www.articlesbase.com/motivational-articles/mastering-your-mind-power-recognize-how-fear-controls-you-641973.html

For more reading on shyness read Christiphor Lane's 'Shyness: How Normal Behavior Became a Sickness' or view his website here

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