Thank You Liberty Beacon!


One of my posts was featured recently on ‘The Liberty Beacon‘, an online news site:

http://www.goforwardtogether.com/2014/04/23/glaxo-smith-kline-purveyors-of-seroxat-the-mental-health-thalidomide-in-widespread-bribery-scandal/

Glaxo Smith Kline, purveyors of Seroxat, the “mental health thalidomide”, in widespread bribery scandal

GSK Bribery

It appears from this report that Glaxo Smith Line the UK drug maker has a serious corruption/bribery problem. We can’t pretend we are surprised, given the generally criminal ethic level of Big Pharma. Nor are we surprised to learn that the company has admitted the number of cases of sales and marketing misconduct it faces is “very similar to those reported by other companies in our sector”. So they are all at it then are they? Of course they are! – Editor

The Liberty Beacon UK highly recommends that you visit GSK : Licence To (K)ill (Seroxat : The Mental Health Thalidomide) for more great articles and exposes of the psychoptropic drug Seroxat. See the featured article here


Check The Liberty Beacon Out Here:

http://www.thelibertybeacon.com/about/

 The Liberty Beacon project (TLB)

Mission Statement and Project Goals

The mission of The Liberty Beacon (TLB) project is to publish pertinent websites and produce media content (podcasts, telepodcasts, videomags, blogs, internet TV shows etc…) as well as to increase access to the abundance of uncoordinated alternative source media to the liberty movement or to any and all who wish to be informed and educated as to reality in this climate of political, social, health and economic turmoil.

One thing we are all aware of is that the MainStream Media is seriously remiss in its stated mission to keep the American people informed in real time on topics of importance by presenting timely and fact based reporting of events as they occur both in this country and across the globe. So TLB will do this in earnest knowing that an informed and educated society cannot and will not be subjugated!

The Liberty Beacon project presently consists of 3 FaceBook pages (and manage over 10 more), 4 FaceBook groups (and admin over 30 more), 4 websites (with 3 more currently under construction) including international sites, a Twitter channel, 3 weekly podcast shows (with several more under development) and a YouTube channel.

Projects currently in progress include setting up a server to produce an in-house internet TV show, the launch of a social site for all of our project associates as well as a plethora of additional linked international websites spanning the globe.

TLB has a close association with approximately 500 groups and pages of like mind on FaceBook and is partnered with several alternative media and health/health tyranny websites. We also benefit from close personal contacts with professionals, authors, media personnel and journalists in at least 30 other countries across the globe that can provide us with real-time information you wont see or hear on the mainstream media.

And this is just the beginning !!!

Roger Landry (TLB)

Founder of The Liberty Beacon project

GSK under growing pressure from UK authorities, lawyers warn


http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10773265/GSK-under-growing-pressure-from-UK-authorities-lawyers-warn.html

“They should lose their License to operate, not fines, and long stretch in Jail”

(comment on the Telegraph article)


Legal experts warn recent developments will have drawn more scrutiny from the Serious Fraud Office

GlaxoSmithKline
GSK has insisted that it does not have a systemic bribery problem, and that any wrongdoing it has unearthed was by rogue salesmen working outside the company’s control processes.

British drug giant GlaxoSmithKline will come under more pressure from prosecutors in the UK and US after admitting that it is investigating bribery allegations in several countries, legal experts have said.

The drug maker has, within the last two weeks, been forced to admit it is looking into bribery allegations in four countries: Poland, Iraq, Jordan and Lebanon.

These admissions come months after the company became embroiled in a major bribery scandal in China, where it was accused of funnelling as much as £320m to doctors and government officials to boost sales. GSK has said it is co-operating with the Beijing authorities’ investigation.

If the allegations are successfully prosecuted abroad, GSK may also have breached the UK’s powerful bribery laws. Britain’s Bribery Act, which counts failure of a company to prevent bribery as an offence, can be applied to domestic companies operating abroad and foreign companies with a presence in the UK.

Reuben Guttman, a director of US law firm Grant & Eisenhofer, said GSK could also be vulnerable to prosecution under America’s anti-corruption laws.

“GSK is a company that trades on our exchanges; a determination that it had engaged in bribery of foreign officials would have implications under the US Foreign Corrupt Practices Act,” he said.

“This means GSK could be subject to monetary penalties in the US and claims could be brought by the SEC or the Justice Department,” Mr Guttman added, pointing out that in the past “sanctions have been in the millions of dollars”.

Nathan Peacey, regulatory partner at law firm Bond Dickinson, said Britain’s Serious Fraud Office was likely to be considering action against the drug maker.

“The SFO is keen to create the impression that they have a number of ongoing investigations and that we can expect to see prosecutions in the not too distant future,” he said.

Mr Peacey said that if GSK was charged by the SFO, the most likely outcome would be a deferred prosecution arrangement (DPA), a new sentencing option which holds back prosecution as long as the company agrees to take certain measures to address any issues. DPAs were introduced in February as an alternative to prosecution, which under the Bribery Act could involve a ban from public contracts.

“The public interest in prosecuting and debarring GSK, one of the UK’s flagship companies, from selling medicines to hospitals the world over has got to be very questionable. If it turned out there were grounds to prosecute, GSK should surely be a prime candidate for a deferred prosecution agreement,” said Barry Vitou, corporate crime partner at law firm Pinsent Masons.

The SFO has not yet launched an investigation into GSK, a necessary prerequisite to charging the company, and will neither confirm nor deny its interest in the drug maker. However Glaxo has said it is in contact with both the SFO and the Department of Justice (DoJ) in the US “as appropriate”, and legal experts believe the authorities have been following the case with interest.

“The reality is that to all intents and purposes GSK is subject to regulatory scrutiny already. GSK is firmly in the cross hairs of the SFO and DoJ,” said Mr Vitou.

“Against this backdrop, a formal SFO investigation is more form over substance at this point. Whether or not GSK is a potential target for prosecution will, of course, be dependent on the actual conduct and not newspaper stories,” he added.

GSK has insisted that it does not have a systemic bribery problem, and that any wrongdoing it has unearthed was by rogue salesmen working outside the company’s control processes.

The company has also pointed out that the number of cases of sales and marketing misconduct it faces are “very similar to those reported by other companies in our sector”.

Legal experts, however, have said recent media attention on Glaxo could nonetheless make it more vulnerable to scrutiny from prosecutors.

“The problem GSK has is that it is a business under the spotlight. In that context, it [the news flow] is extremely unhelpful,” said Mr Vitou.

Mr Peacey added that the growing list of countries where GSK is investigating alleged bribery “makes it feel like it will be harder for them to demonstrate a single isolated incident”.

What I believe


truthman30:

Seroxat Secrets was one of the first Seroxat blogs covering the Seroxat and GSK issues, great blog, and I think this post deserves a re-post …

Originally posted on seroxat secrets...:

I believe Seroxat is defective and dangerous.

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

I believe that Seroxat is addictive.

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

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

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

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

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

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

View original

Who’s Afraid Of Sidney Wolfe? : GSK Tops Corruption Scales With 7.56 Billion In Penalties And Fines Since 1991


Corrupt and Criminal Pharmaceutical Companies

http://blogs.bmj.com/bmj/2014/04/15/the-bmj-today-gsk-and-paying-doctors-to-speak-on-its-behalf/

Not everyone is convinced by their public show of goodwill. In his regular column, Sidney Wolfe, founder and senior adviser in the Health Research Group at Public Citizen, in Washington analysed all civil and criminal penalties paid to the US federal and state governments by pharmaceutical companies from January 1991 through 18 July 2012.

“GSK topped the list of repeat offenders with total criminal and civil penalties of $7.56bn since 1991, comprised six different federal settlements and an additional number with states,” he wrote.

But it seems as though bad news follows the company as they try to build its image. Following investigations in China and Iraq, Shelley Jofre, BBC Panorama correspondent, has found that GSK is under investigation in Poland for allegedly bribing doctors there.

In a feature, she writes that it’s alleged that GSK sales reps in the region of Lodz, Poland’s third largest city, paid doctors as recently as 2012 to boost prescriptions of some of the company’s best known drugs.

A spokesman for the Lodz public prosecutor’s office, Krzysztof Kopania, said that one GSK regional manager and 11 doctors have been charged in connection with corruption allegations for offences committed in 2010-12.

In response, GSK said: “Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company,” the company added. “The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result. We continue to investigate these matters and are co-operating fully with the CBA [the anti-corruption bureau in Poland].”

Whilst such problems arise, GSK’s ability to shake off past reputation and build one of trust and scientific integrity, might be made that bit tougher.

Deborah Cohen is investigations editor, The BMJ.

Sidney Wolfe

150 Less ‘Rogue’ Employees At GSK… : GSK Sacks Over 150 Staff In China…


http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html

GSK cuts 150 China staff for improper sales practices
By Hui Zhi | Thursday, April 17, 2014 at 7:08AM

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).
 
The mass firing came ten months after bribery allegations emerged against the company.

Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions. 

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.



The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees.

“Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)
_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.
- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

Whistleblower Greg Thorpe: GSK Have Used Dangerous Tactics To Drive Sales To Treat Kids


Drug firms have used dangerous tactics to drive sales to treat kids

By Christopher N. Osher and Jennifer Brown
The Denver Post

Posted:   04/14/2014 12:01:00 AM MDT | Updated:   about 8 hours ago
Whistle-blower. Greg Thorpe, a former sales representative for GlaxoSmithKline, sits at a desk in Florida with papers from the case in which he alleged the
Whistle-blower. Greg Thorpe, a former sales representative for GlaxoSmithKline,
sits at a desk in Florida with papers from the case in which he alleged
the company encouraged doctors to prescribe antidepressants to
children when the FDA had not approved the drugs for pediatric use.
Glaxo agreed to pay $3 billion to the federal government to settle the case.
(Brian Blanco, Special to The Denver Post)

Pharmaceutical companies wooed academic leaders, ghostwrote articles, suppressed damaging health data and lavished doctors with gifts to make prescribing powerful psychotropic drugs to children a blockbuster profit center, a trail of lawsuits over the past two decades shows.

As a Colorado Springs sales representative for GlaxoSmithKline, Greg Thorpe tried to put a stop to the practice. His manager wrote him up for not being a “team player” after he objected to the free spa treatments and pedicures, hunting trips, tickets to sports games and skiing junkets that his supervisors expected him to give out to doctors and others.

“The sky was the limit,” said Thorpe, whose whistle-blower lawsuit against his former employer ended with a $3 billion settlement with the federal government. “Those who spent more money got rewarded because they were positioning the company for more business. And it did pay off.”

It was just one part of the massive effort by the pharmaceutical industry to drive sales of antidepressants, antipsychotics and other psychotropic drugs to treat poor children, often for uses never approved by federal regulators.

The push succeeded in reaching a particularly vulnerable group: foster children, who experts say often struggle to cope with trauma that psychotropic drugs don’t heal.

A Denver Post investigation into antipsychotic use found that foster children were prescribed the potent mood-altering drugs at a rate 12 times higher than that of other children on Medicaid in Colorado in 2012. Dosages and rates of multidrug prescriptions also were high among foster children in this state.

Colorado officials knew about rising prescription rates and dosages of psychotropic drugs, which include antipsychotics and antidepressants, as early as 2007 but didn’t convene a panel to address the issue for more than five years.

High rates of psychotropic drug use among poor and foster children didn’t occur by mistake, government investigators say. Court documents filed in health care false-claims lawsuits show that drug companies closely tracked the prescribing habits of doctors in the Medicaid program, which pays the health care of the poor, including foster children.

In Colorado, nine of the top 10 most prescribed drugs for foster children in the Medicaid program are psychotropics, according to the most recently available data. In contrast, for non-foster children, only one psychotropic is among the top 10 most prescribed drugs in Medicaid.

Pharmaceutical companies in 2008 alone spent nearly $800 million on sales representatives making visits to health care professionals for antipsychotics and antidepressants, a December 2009 report from the nonpartisan Congressional Budget Office found.

And that’s not counting additional money paid to health care providers for speeches, consulting and research, some of which went to Colorado doctors.

John T. Hardy, an adolescent and child psychiatrist in Pueblo, received about $400,000 from 2009 through 2011 in travel, consulting and speaking fees and meals from drug companies, including antipsychotic manufacturers Eli Lilly and Pfizer, according to a ProPublica database.

A variety of psychotropic drugs — some simultaneously — are used by many children in the foster-care system. Olanzapine, sold under brand names

A variety of psychotropic drugs — some simultaneously — are used by many children in the foster-care system. Olanzapine, sold under brand names including Zyprexa, is used to treat schizophrenia and acute mixed or manic episodes, while Seroquel, or quetiapine, is used to treat nervous, emotional and mental conditions such as schizophrenia and symptoms of bipolar disorder, or manic-depressive illness. All of these drugs are atypical antipsychotics. (Helen H. Richardson, The Denver Post)

A Colorado panel studying the high use of psychotropics among foster children in Colorado reviewed Medicaid drug prescriptions and found that in 2012, Hardy was one of the highest volume prescribers in the state of mental health drugs.

“I do what’s best for my patients,” said Hardy, adding that pharmaceutical money doesn’t influence his prescribing decisions. The number of psychotropic prescriptions Hardy wrote could not be obtained by The Post.

Lucrative drugs

Far from the niche market they originally served, antipsychotics these days are some of the most lucrative drugs, with sales topping $18 billion in 2011, more than sales of vaccines and triple the amount spent on antipsychotics in 2002, national drug-sales data show.

More than 1 million children in America take antipsychotics annually, and tens of thousands of those are younger than 5, a 2009 Food and Drug Administration advisory committee study found.

One in 25 children in the nation between the ages of 12 and 17 took antidepressants in 2011, according to a study by the Centers for Disease Control and Prevention that also found that use of the drugs in Americans of all ages increased by 400 percent in the past two decades.

Pharmaceutical firms say the explosive growth has filled an important need and deny that the growth was driven by inappropriate marketing. Officials with those companies say many more people whose symptoms haven’t yet been addressed and aren’t taking the drugs could benefit from taking antidepressants and anti-psychotics.

But many child health experts warn that the increase comes at a tremendous cost to public health programs and at great risk to children. Antipsychotics have been linked to weight gain and diabetes in children and growth of breasts in boys. The FDA has warned that antidepressants increase suicidal behavior and thinking in children and adolescents.

“We really don’t know enough about the safety and effectiveness of these drugs,” said Dr. Tobias Gerhard, an assistant professor at Rutgers University who has studied the growth in prescribing antipsychotics to children and adolescents.

While antipsychotics’ effectiveness and safety remain hotly debated, the prescription of them has become standard practice for treating children for “off-label” uses that have never been approved by federal regulators.

At least three-quarters of the children prescribed antipsychotics through Medicaid took them for issues beyond FDA-approved uses for the drugs, a Rutgers University study found. The drugs often are prescribed for attention-deficit hyperactivity disorder, conduct disorder, anxiety or depression, none of which is a condition the FDA has approved for treatment by antipsychotics in children, the study found.

“It’s an issue that’s getting a lot of attention, but it’s very difficult for payers to impact the prescribing behaviors of clinicians in America,” said Dr. Stephen Crystal, who led that research team. “Major manufacturers of these drugs have paid fines in the hundreds of millions of dollars for alleged improper marketing, in some cases for use in kids.”

Doctors are free to prescribe drugs for any symptom, even if that results in a drug use that has never been approved by the FDA. But it’s against the law for pharmaceutical firms to encourage doctors to prescribe off-label.

$13 billion paid

Since 2008, pharmaceutical companies have agreed to pay more than $13 billion to resolve U.S. Department of Justice allegations of fraudulent marketing practices. Among the cases:

• Eli Lilly distributed videotapes to doctors titled “The Myth of Diabetes” when marketing its antipsychotic Zyprexa, despite being aware of studies showing those taking the drug had a higher rate of diabetes, government investigators say. The government accused the company of pressing doctors to prescribe Zyprexa to children and collected a $1.4 billion fine.

• Pfizer, which paid a $2.3 billion fine to settle a whistle-blower lawsuit, hired 250 child psychiatrists to help market its antipsychotic Geodon despite there being no approved pediatric use for the drug from the FDA. As part of the settlement, Pfizer denied any wrongdoing.

• AstraZeneca paid a fine of $520 million to resolve allegations that it promoted the antipsychotic Seroquel to treat aggression, sleeplessness, anxiety and depression when the FDA had approved the drug only to treat schizophrenia and, later, bipolar mania. Government investigators said the company targeted child physicians.

• Johnson & Johnson targeted what it called key opinion leaders to help promote the use of anti-psychotic Risperdal in children, the government alleged in another lawsuit that resulted in a $2.2 billion fine to resolve criminal and civil allegations.

The GlaxoSmithKline whistle-blower case in which Thorpe was a plaintiff included allegations the company encouraged health care providers to prescribe antidepressants to children when the FDA had not approved the drugs for pediatric use. Glaxo agreed to pay $3 billion to the federal government to settle the case, the largest health care false-claims act settlement ever.

Government investigators found that Glaxo aggressively marketed Paxil off-label as curing everything from depression to shyness in children. Increasing pediatric prescriptions of the drug was a key business strategy for the company, one that helped propel Paxil to $2.7 billion in sales in the United States in 2003, documents show.

Between 1994 and 2001, the company conducted three trials using Paxil to treat depression in those under 18. None of the trials showed the drug helped depressed children, the government asserted. But the trials showed that Paxil had harmful effects and increased the likelihood of suicidal thinking and behavior in children.

Despite those damaging findings, the company hired a firm to help it publish a favorable article about Paxil in the Journal of the American Academy of Child and Adolescent Psychiatry.

It wasn’t until 2006, two years after the FDA ordered all manufacturers of antidepressants to provide cautionary warnings on their labels, that Glaxo changed Paxil’s label to note the suicidal risk and sent letters to doctors alerting them of the risk.

Glaxo officials say the company has made broad changes to its drug-marketing policies. It no longer provides bonuses to sales representatives for increasing prescription volume. Glaxo also has begun publishing all drug-trial results and says it will stop offering to pay doctors to give speeches touting drugs.

Industry trade groups also have adopted new policies restricting the gifts that drug sales representatives can offer physicians.

But Thorpe said the changes come too late. The public still is left struggling with high prescription rates to treat the very young, he said.

“An off-label script is a script that keeps giving whether you stop promoting the drug or not,” he said. “A doctor will keep prescribing the drug if he’s become comfortable with it. The patient likes the drug, so they will want it. It becomes a profit for life.”

Thorpe said he became disgusted with Glaxo’s all-expense-paid trips to Jamaica and Hawaii for physicians and their guests to train them how to give speeches touting the drugs.

Some speakers were paid more than $500,000 annually to talk up the benefits of treating children with antidepressants when the FDA had never approved the drugs for such uses, documents show. The company budgeted as much as $6.8 million annually to entertain doctors in luxury sky-box suites at sporting venues, according to the documents.

Thorpe left the company where he had worked 24 years and later filed his lawsuit. It took nine years for government prosecutors to join the suit.

In 2012, Glaxo agreed to settle. Thorpe’s cut for helping the government recuperate money drained from the Medicare, Medicaid and veteran programs was $20 million.

Off-label uses pushed

Glaxo was not the only company to use such tactics. Other firms pushed for off-label uses of newer antipsychotics, known as atypicals, contending they worked better than older versions.

During the 1990s, Johnson & Johnson received FDA approval for its new antipsychotic drug, Risperdal, to treat schizophrenia in adults. But the agency repeatedly rejected J&J’s efforts to obtain approval for children.

The company had not proposed any child or adolescent psychiatric disorders that Risperdal would treat, the FDA noted in one denial letter. In one meeting, FDA officials worried that using the drug to treat conduct disorder in children would amount to creating a “chemical straitjacket.” It was not until 2006 that FDA officials approved the drug for the limited use of treating autism in children.

Still, the company trained its sales force to market the drug to primary-care doctors and child psychiatrists well before that 2006 approval. More than 1,500 child psychiatrists, targeted due to their antipsychotic prescribing history, each received at least 12 calls from J&J sales representatives in 2000 , documents show.

In 2003, when Risperdal still had no FDA-approved use for children, the company developed a “Back to School Bash.” The marketing plan aimed to increase prescriptions of Risperdal to children and adolescents with ice-cream parties and free snacks and lunches.

One district manager praised a sales representative for promoting a new, faster-dissolving version of Risperdal by providing starter kits to child psychiatrists. The kits included free Risperdal samples, coupons for the drugs, lollipops and small toys, a performance review shows.

Other initiatives that J&J launched for Risperdal created problems for the company.

A research partnership with a prominent child psychiatrist backfired when it was revealed that the psychiatrist and two others had accepted $4.2 million from pharmaceutical companies from 2000 to 2007.

J&J hired a marketing firm to ghostwrite articles attributed to academicians who had done little to no work, according to a report from Dr. David Rothman, a Columbia University professor who studies medical industry ties. Rothman was an expert witness for the Texas Attorney General’s Office in a lawsuit against J&J.

Along the way, the company kept from the public key health data showing troubling risks of Risperdal.

In the pediatric market, the company downplayed the risk that the drug would cause the growth of prolactin in boys, which can cause them to develop lactating breasts, said David Kessler, a former FDA chief who was an expert witness in personal-injury lawsuits filed against Janssen Pharmaceuticals Inc., a J&J subsidiary.

Kessler found the company was responsible for medical-journal articles that gave misleading information about the results of studies into the prolactin issue.

In fact, the company’s studies showed breasts developing in about 10 out of 100 children taking the drug, Kessler reported.

“Janssen’s promotion of Risperdal, a powerful drug, for nonapproved uses in the most vulnerable children is deeply troubling,” Kessler stated in his report.

Janssen officials said those activities are in the past.

“Janssen is committed to ethical business practices and has policies in place to ensure its products are only promoted for their FDA-approved indications,” said spokesman Robyn Reed Frenze. “In fact, the company’s policies meet and often exceed the legal requirements of all jurisdictions it operates within and all local industry codes of which it is a member.”

While the court settlements seem big, they don’t compare to the profits the sales of the drugs generate, said Stephen Sheller, a Philadelphia lawyer who worked with the justice department on a whistle-blower lawsuit involving Risperdal.

J&J generated $4.55 billion in annual sales of Risperdal, 18 percent of its pharmaceutical sales, according to financial reports the company filed with federal regulators in 2008.

Meanwhile, lawsuits against pharmaceutical firms alleging violations of the federal false-claims act continue to be filed at a rapid pace. The justice department says 500 health care fraud act lawsuits were filed last year, the most ever in a year.

“Nothing is going to change significantly until a few top people go to jail,” Sheller said. “There is too much money to gain by marketing the drugs illegally.”

Christopher N. Osher: 303-954-1747, cosher@denverpost.com or twitter.com/chrisosher


About the drugs

Psychotropics: A broad class of medications made of chemicals that alter brain function, including mood and behavior; these include antidepressants, anti-anxiety drugs and attention-deficit-disorder drugs.
Antipsychotics: The most powerful drugs in the broader class of psychotropics; have been linked to diabetes and weight gain in children, and growth of breasts in boys.
Atypicals: The latest generation of antipsychotic medications, with brand names such as Abilify, Zyprexa and Risperdal.


About the seriesThis investigation by The Denver Post into psychotropic drug use by foster children stems from The Post’s “Failed to Death” series on Colorado’s child-welfare system that ran in 2012.
The overprescription of powerful psychotropic medication to foster children is a national epidemic — yet in Colorado, efforts to curb the problem lag some states.
The Post obtained unpublished state data and reports, interviewed foster families and children, reviewed other states’ efforts and examined promising new therapies.

Sunday: Foster kids are prescribed powerful drugs that alter brain function at rates far higher than other children. A growing number of experts say this is not only unnecessary, but harmful.

Monday: Over decades, the pharmaceutical industry pushed aggressively to market psychotropics to children and tap into the lucrative Medicaid system.

Tuesday: New therapies to repair developmental delays in children’s brains caused by abuse and neglect are taking hold. Proponents advocate for more therapy and fewer medications.

Wednesday: Other states have been more aggressive and more effective than Colorado in establishing policies to reduce prescriptions of psychotropics to foster children.


Read more: Drug firms have used dangerous tactics to drive sales to treat kids – The Denver Post http://www.denverpost.com/investigations/ci_25561024/drug-firms-have-used-dangerous-tactics-drive-sales#ixzz2zHEJfrM5
Read The Denver Post’s Terms of Use of its content: http://www.denverpost.com/termsofuse

Silly Man Of The Day (or possibly of the year): Stephen Whitehead of the ABPI (Association of the British Pharmaceutical Industry)


stephen-whitehead-200

SWJust watching Panorama’s recent documentary (for the second time) on how the pharmaceutical industry influences doctors and the medicines they prescribe, and I think that Mr Stephen Whitehead (of the ABPI)- speaking on behalf of the UK pharmaceutical industry- definitely deserves the accolade of Silly Man Of The Day..

There are many other adjectives which others might use to describe Stephen Whitehead, but personally I think he is just a very silly man. His comments in defense of the corruption of doctors by pharmaceutical companies are absolutely ridiculous and you would have to wonder who was coaching Whitehead? Did he not get advice? Did he not watch previous BBC  Panorama documentaries? Did he not know he was dealing with Shelley Jofre? (One of the best investigative journalists of the pharmaceutical industry in the UK).

How about this for a dialogue?

(from appox the last 10 mins of “Who’s paying your doctor?”)

Stephen Whitehead :”We should never fool ourselves that doctors will be overly swayed by some of this commercial activity given that they have seen a lot of other information”..

Shelley Jofre: “Why on earth would these drug companies spend all this money on doctors if it didn’t sway their prescribing?”

Stephen Whitehead:  “Well..  that’s an interesting question isn’t it..

Shelley Jofre: “But why would they?”

Stephen Whitehead : “Well…My view is.. it should sway their prescribing”.. “and I will absolutely categorically say that”…It’s absolutely appropriate for doctors to prescribe medicines for patients that need them.. .it is up to the doctor to decide what is right… “

What exactly is Stephen Whitehead on about? He seems to be contradicting himself..

Basically it seems that Mr Whitehead begins by saying that doctors would not be ‘overly’ swayed by drug company symposiums (or sponsored conferences, exhibits, lectures etc)

but then in the next breath he says that they should be swayed and that drug companies should be able to influence their prescribing!… So which is it Whitehead?… Are doctors not influenced by drug companies? Or are they? (I think we all know the answer to that one)

At least get your script right before you are interviewed.. Whitehead you Silly Man!…

It seems that Whitehad is so far indoctrinated into the greedy industry he so eagerly defends, that he has lost the ability to make sense..  he absolutely failed to defend the industry on Panorama and his gibberish proves that he doesn’t know his arse from his elbow!…

We all know the pharmaceutical industry is corrupt, we all know that doctors have been corrupted by the industry that the ABPI supports, so stop with the silly PR crap Stephen, nobody believes it- it’s getting boring- and your lame attempt at defending the industry was thoroughly pathetic, not to mention -incoherent.

http://www.quitam-lawyer.com/sites/quitam-lawyer.com/files/02.03.12%20-%20GSK%20–%20Exhibits%20to%207AC%201-752.pdf

People often say that, 1% of the human population are sociopaths and that it is these callous, devious individuals, with no empathy, or regard for others- who rise to the top of multinationals, banks, politics etc…  I am inclined to agree somewhat in the sociopath theory( how else could you explain GSK for example?), but I also reckon that there is a sizable percentage of the population who are just silly, idiotic, moronic, easily led, and utterly gormless, and it’s these individuals who also end up in jobs which require them to be just that…

… mindless corporate minions to the cleverer sociopaths further up the greasy ladder…

Stephen Whitehead You Are A Very Silly Man!…

And once again, you have missed the point completely!…

From Seroxat Secrets 2012 :

 

http://seroxatsecrets.wordpress.com/2012/10/22/stephen-whitehead-abpi-missing-the-point-completely/

Stephen Whitehead, ABPI – missing the point completely

I read this article in the New Statesman today and made me really quite annoyed…

It featured a letter written to the New Statesman by the CEO of the Association of the British Pharmaceutical Industry (ABPI), Stephen Whitehead, as a response to issues Ben Goldacre’s new book, Bad Pharma.

It’s amazing just how stupid a response it is – in fact I have to ask if Stephen has actually bothered to read the book at all or if the’s just gone into classic big Pharma knee jerk mode (after all, Stephen did spend 10 years of his career working at Glaxo and Eli Lily).

But no matter, as the New Statesman has printed Ben’s reply to the response.

However the comment I really found strange from Stephen Whitehead was this “…references to companies (GSK, Lilly, Pfizer) being fined are all examples from the US and simply not relevant to the UK market…”

GSK’s fine was, to remind you, the largest healthcare fraud settlement in history at $3bn.

How it isn’t relevant to the UK is beyond me – because what we’re talking about here is not just illegal marketing of drugs – not just bribing doctors to prescribe GSK products – what we’re talking about here are dead people.

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

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

How’s that “simply not relevant” to patients in the UK, Stephen?

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