Hey Emma Walmsley…As A Mother Of 4… What Do You Think Of Seroxat Study 329? And the Paroxetine Child Suicides?…Does This Make You ‘Proud’ To Be Part Of GSK?…


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Mother-of-four, 47, who says having a family is the best decision she’s made becomes the most powerful woman on the FTSE after taking the helm at drugs giant GlaxoSmithKline

  • Drugs giant GlaxoSmithKline names Emma Walmsley as chief executive

  • Mother-of-four will replace Sir Andrew Witty when he retires next March

  • Promotion means she becomes seventh female FTSE 100 chief executive

  • She says getting married and having four children was her ‘best decision’

http://www.ibtimes.com/new-paxil-warnings-teens-prompt-fury-former-patients-2108017

New Paxil Warnings For Teens Prompt Fury From Former Patients


Kaili Butin still has faint scars on her wrist from the day she tried to kill herself. A family physician had prescribed GlaxoSmithKline’s antidepressant Paxil to treat her depression. It was the fall of 2000, her sophomore year of high school, and she had stopped caring about schoolwork and lost interest in her friends.

“I wanted something to make me feel better,” she says. “I wanted to be a normal teenager. I saw my friends and none of them felt the way I felt.”

Butin was among millions of American teens who took Paxil in the early 2000s. Her doctor’s recommendation helped the antidepressant overtake the competition to garner the highest number of new prescriptions of any drug in its class in 2000. Sales of the pill increased by 17 percent to hit $2.4 billion. Butin, now a 31-year-old accountant living in Ankeny, Iowa, is angry about newly revealed information that GlaxoSmithKline withheld from the public regarding Paxil’s danger to teenagers. 

I presume you might be reading Emma …

Don’t you say in this video (here) that”

…society wants big business and big pharma to continue to close the trust deficit that has been widening up….”

Why do you think that the trust deficit continues to widen Emma?

Could it be because GSK continue to be callous and corrupt?…

Do you think that those harmed by Seroxat will ever trust GSK?

Do you think with GSK’s track record that – the public in general- will ever trust them?

I don’t think you could seriously expect them to...why would they?

 


http://davidhealy.org/study-329-continuation-phase/

Study 329 Continuation Phase

September, 27, 2016 | Reply

How Do GSK Spin A (Head-Line Grabbing Land-Mark) Study That Shows Seroxat Kills Kids?


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“The parents of an 18-year-old girl who committed suicide have called for better regulation of the drug she was prescribed.

Alfred and Stephanie Gatchell, from Newhaven, blame the anti-depressant Seroxat for the death of her daughter Sharise.

Now the couple, who moved to the UK from South Africa with their daughter in search of a better life, want doctors to be told not to prescribe Seroxat to people of Sharise’s age.”

(BBC News 2003)


“An Australian-led review of a popular anti-depressant drug has found it can tip young people into suicide and is no more effective than a placebo.

The research team also uncovered evidence that the drug’s manufacturer downplayed its deadly side-effects and exaggerated its benefits.

The study, published in the British Medical Journal, reviewed data used by pharmaceutical companies to help market the drug, which is sold in Australia under the names Aropax and Paxil. It is also known as paroxetine.

The company’s communications director, Bernadette Murdoch, told The World Today “we did provide an unprecedented level of data to the research team”.

(Sept 2015- ABC Australian News)


The restoration of GSK’s Seroxat study 329 is making head line news across the globe, and twitter has literally exploded with Seroxat/Paxil related tweets trending like wildfire. For those of us prescribed this horrific drug, this is good news, however not so much for the manufacturers GSK. So how do GSK counter such bad news? Seroxat was prescribed to millions of kids worldwide, and this study proves GSK knew it was harmful, so arguably what we are talking about here is perhaps a case of corporate manslaughter? or maybe multiple cases of corporate manslaughter and multiple attempts at corporate manslaughter? and if so, how does GSK spin an accusation of corporate manslaughter? how does their PR department spin the killing of kids from a harmful drug?

Well, they send out people like Bernadette Murdoch (The Australian GSK Communications spokesperson). Bernadette, it seems, is perhaps GSK Australia’s version of Alastair Benbow. Benbow was carted out by GSK to defend Seroxat and its link to suicide in the early 2000’s. He once said that there was ‘a small class of suicidal children’ in his estimates. We know now that the way GSK promoted Seroxat/Paxil (off label particularly) resulted in potentially many thousands of ‘small classes of suicidal children’ prescribed this drug.

Bernadette’s recent comments (on behalf of her paymasters – GSK) alarmed me a lot so I thought I would bring attention to them, and also- for the record- I’d like to correct Bernadette, because she seems to be selectively missing some very important details about this grave Seroxat situation; she also seems to underestimate the impact that the restoration of this study has had world-wide, and indeed the impact it will have for many years to come, both in academia and public discourse.

The 329 RIAT restoration team have said on numerous occasions just how difficult and overwhelming the whole process of obtaining, logging and reading the data was in this case. This is because GSK have set up a frustrating system whereby the only way to see the data is through a difficult ‘periscope’ type method. It is a miracle that the researchers had the will and tenacity to over come this (what I think is a- deliberate) obstacle, and it is a testament to their characters that they pushed ahead despite the immensely stressful difficulties presented to them. In light of this, it is therefore ironic, that Bernadette tries to spin it that GSK somehow had a difficult time presenting the data. GSK might have been slightly inconvenienced because they had to provide data from their study which was spun at the time as positive, when in fact it was negative; kids died because of this: these situations don’t equate to each other.

They might have presented an ‘unprecedented level of data’, but the way they presented it was akin to stonewalling, and anyhow so what if they provided the data? After 20 odd years on the market, surely they should have presented the data in the first place? Does Bernadette think her paymasters should be praised for presenting data which should never have been concealed to begin with? Anyhow, it was also the researchers who had the difficulties, not GSK, and those harmed by Seroxat have had more difficulties that Bernadette could ever imagine.

Furthermore, what Bernadette fails to mention is- this study was re-interpreted by the researchers because the original one is still being cited in order to justify the prescribing of Paroxetine to kids (mainly off label). Kids died because of the original study- how does Bernadette not understand how sinister this is? There is also the fact that there are many adults harmed and damaged from Paroxetine also (Bernadette doesn’t seem to concerned with this at all). Listening to someone like Bernadette, (or any of the other GSK mouth pieces) if you didn’t know much about Study 329, you would think that this is the first time the data had been analyzed, however it is precisely because GSK spun the negative data (from the first dodgy study) in the first place that the researchers were intent on correcting the record.

Kids died because GSK lied.

Many more were harmed.

Bernadette glosses over this, but I suppose that is what she is paid to do.

“It is not an easy process,” she said.

“These studies were conducted in the ’90s, many years ago when computer systems were very different. A lot of the notes were handwritten but we did provide all of the data that was requested by the team so that they could carry out the reanalysis.”

Bernadette is correct, these studies were conducted in the 90’s however that has nothing to do with the questions of manipulating the study itself in order to provide a deceptive result. Study 329 was a fraud. Kids died because of it. Bernadette doesn’t seem to see just how sick and twisted this is. The 90’s aren’t that long ago, and anyhow, Seroxat is still prescribed to children and adults, so I really don’t see her point here. GSK still profit off long term addicts. Furthermore, despite Seroxat making depressed kids more suicidal, GSK also made billions on it- so they have effectively profited by destroying lives. I don’t see how this can be spun as a positive thing…

Ms Murdoch said it was important to remember that “when a medicine is approved for use, it’s not just the pharmaceutical company that makes that decision”.

“There are lots of checks and balances in between, so a regulator uses all of the data that’s available on a medicine before recommending it for use for a patient,” she said.

Again, we see that Bernadette is trying to deflect the seriousness of this study and its affects on kids. She seems to be trying to pass the buck to the regulator. The regulators are toothless, incompetent, and useless. That’s a fact, however, GSK did the study, GSK pushed this drug on kids, it’s GSK who are ultimately responsible for destroying these kids lives. Kids died or were harmed because of this fraud. There is no avoiding this fact. Her comment about ‘checks and balances’ is utterly meaningless. When you have a drug company intent on manipulating results and hood winking the regulator, the system itself is useless. There were no checks and balances, that’s the whole point! and what little there was- was corrupted!

“In relation to the findings from the team’s analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paraxetine, are not suitable for children.

“This is widely known and clear warnings have been placed on the product label for more than a decade.”

Her last comment (above) really galls me. Bernadette is trying to make out that this study is old news. The warnings were put there because of Shelley Jofre’s reporting on BBC panorama’s four documentaries about Seroxat, a decade of litigation, department of justice investigations (particularly in 2004 and 2012) and much campaigning from the Seroxat users group, bloggers like me, Fid, and Seroxat secrets, David Healy’s RIAT team, and others.

This has been 14 years in the making. This is not old news!

GSK have been forced to release data, bit by bit, drip by drip, but Bernadette fails to mention any of this. She’s trying to make it seem like GSK were being transparent. This is twisting the facts.

I don’t know how she sleeps at night…

Her paycheck must help.

Maybe she should watch this documentary, it might help her understand a little more about the drug company she works for and let me remind Bernadette, the study she is defending (Aropax/Paxil/Seroxat 329), and the company she works for (GSK) deliberately misled doctors, the public and parents of children- this led to deaths of kids.

How can you reconcile that?

These deaths were entirely preventable.

You just can’t defend the indefensible Bernadette.

BM

Contact:

Bernadette Murdoch, Communications Director Australasia

0449 950 745 or Bernadette.l.murdoch@gsk.com 

BernadettetBern


http://study329.org/

GSKstudy329

“It’s hard to think there wasn’t some mischief being done when a severe suicide attempt requiring hospitalization was coded as ’emotional liability,'” Jureidini said during the press call about one of the specific cases they reviewed and re-classified.

http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/53583

http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-wrongdoing/

Paxil
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug.

A government probe was launched in 2002, and it was discovered that Paxil, as well as several other antidepressants, were no more effective than placebo in treating depression in kids. Indeed, between 1994 and 2001, Glaxo conducted three clinical trails of Paxil’s safety and efficacy in treating depression in patients under 18, and all three studies failed to pass muster.

One clinical trial, known as Study 329, found that teens who took the drug for depression were more likely to attempt suicide attempt than those receiving placebo pills. Glaxo hired a company to prepare a medical journal article that downplayed Paxil’s safety risks, including increased risk of suicide, and misrepresented data to trump up the positive results of the study. The article was published in 2001, falsely reporting that Paxil was an effective treatment for child depression.

Prosecutors accused Glaxo sales representatives of then using the article to promote the use of the drug for depressed youth. Sales reps invited prescribing psychiatrists to luxury resorts for “Paxil forum meetings” where they were treated to fancy dinners and free entertainment like sailing trips and balloon rides.

Reports of teens committing suicide while taking Paxil began surfacing in 2003, and the FDA discovered that 10 of the 93 Paxil patients in Study 329 had attempted suicide or thought about it, versus one out of the 87 patients on placebo. In 2004, the FDA added a black-box warning on the drug’s label about the increased risk of suicidal thoughts in teens who take it.


http://www.cirmagazine.com/cir/nothing-to-sniff-at.php

In October 2009:

The latest development is the approval by the European Medicines Agency (EMEA) of two flu vaccines, Pandemrix, (GlaxoSmithKline) and Focetria (Novartis). Licenses will be granted on approval by the European Commission. These are a key part of the flu strategies of governments around the world. In the UK, the government has contracts in place to supply up to 132 million doses of vaccine.

There has been some concern, however, about the speed at which the new vaccines have appeared.

GlaxoSmithKline spokesperson, Bernadette Murdoch, explained that although the vaccine is new, a lot of the work on it took place before the pandemic was declared. “We carried out clinical studies which led to the 2008 approval of the vaccine, and we are carrying out further 16 clinical studies, involving about 9,000 people and all that data will be provided to assess that. We are still going to continue to monitor its safety as we go forward.”

Researchers link Pandemrix flu vaccinations to narcolepsy

Lawrence Steinman. (Courtesy of Lawrence Steinman)

An international team of researchers has found evidence that the GlaxoSmithKline Pandemrix flu vaccination – which was widely distributed during the 2009 swine flu pandemic – may have caused rare cases of narcolepsy. Their study, which was published July 1 in Science Translational Medicine, described that the vaccination stimulated antibodies to attack receptors in brain cells that help regulate sleep.

Lawrence Steinman, a professor of pediatrics and of neurology and neurological sciences at the Stanford University School of Medicine, and his collaborators sought to determine why the Pandemrix vaccine

According to the study, Pandemrix, which was given to more than 30 million Europeans, strongly suggested to trigger an autoimmune reaction that led to narcolepsy in some people who are genetically at risk.
The researchers propose a “hit-and-run” mechanism where high levels of the H1N1 protein stimulate the production of large amounts of antibodies, which may remain in the blood for months, to both the virus and the hypocretin receptor. Under certain conditions, the blood-brain barrier can be altered, allowing the antibodies to enter the brain where they latch onto hypocretin receptors, possibly targeting these brain cells destruction by the immune system.

BM


http://www.thejournal.ie/pandemrix-narcolepsy-link-study-1447040-May2014/

“Our study found a significant, 13.9-fold higher, risk of narcolepsy in children/adolescents vaccinated in Ireland with Pandemrix compared with unvaccinated children/adolescents,” said the researchers.


So far 31 million doses of Pandemrix have been administered in 47 countries, GSK said. It has received 335 reports as of Jul 6 of narcolepsy in people who were immunized with Pandemrix, of which 68% were from Finland and Sweden.

http://www.cidrap.umn.edu/news-perspective/2011/07/ema-narcolepsy-review-restricts-pandemrix-use-kids-teens

(2012) GlaxoSmithKline Bribes..


http://www.theguardian.com/commentisfree/2012/jul/04/glaxosmithkline-big-pharma-not-working?CMP=share_btn_tw

GlaxoSmithKline’s bribes are evidence that Big Pharma isn’t working

Philip Ball The inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink

Wednesday 4 July 2012 14.45 BST Last modified on Wednesday 21 May 2014 05.11 BST

Comments 132

Perhaps the most shocking thing about the latest GlaxoSmithKline drug scandal is that malpractice among our overlords still has the ability to shock at all. Yet despite popular cynicism about doctors being in the pockets of the drug companies, there remains a sense that the people responsible for our healthcare are more principled and less corruptible than expenses-fiddling politicians, predatory bankers, amoral media magnates and venal police.

If this were a junk food company lying about its noxious products, or a tobacco company pushing ciggies on schoolkids, we’d be outraged but hardly surprised. When a major pharmaceutical company is found to have been up to comparable misdemeanours – bad enough to warrant an astonishing $3bn fine – it seems more of a betrayal of trust.

This is absurd, of course, but it shows how the healthcare industry benefits from its proximity to the Hippocratic oath. “Do more, feel better, live longer” GSK purrs. How can we doubt a company that announces as its priorities as “improving the health and wellbeing of people around the world” and “being open and honest in everything we do”?

Now GSK admits that, in effect, it risked damaging the health of people around the world, and was secretive and fraudulent in some of what it did. Among other things, it promoted antidepressant drug Paxil, approved only for adults, to people under 18. It marketed other drugs for non-approved uses; it suppressed scientific studies that didn’t suit (for example over the heart attack risks of its diabetes drug Avandia), and over-hyped others that did. It also hosted outings for doctors in exotic locations and showered them with perks, knowing that this would boost prescriptions of its drugs.

 

Prescription for Glaxo: A New Boss? (Bloomberg)


http://www.bloomberg.com/news/articles/2015-05-05/prescription-for-glaxo-a-new-boss-

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5:01 AM BST
May 5, 2015

Incoming Chairman Of GlaxoSmithKline Plc Philip Hampton

Incoming Chairman Of GlaxoSmithKline Plc Philip Hampton, is no stranger to big challenges or high-profile roles. He led the board at Royal Bank of Scotland Group Plc after the biggest taxpayer bailout in U.K. history.
Incoming Chairman Of GlaxoSmithKline Plc Philip Hampton, is no stranger to big challenges or high-profile roles. He led the board at Royal Bank of Scotland Group Plc after the biggest taxpayer bailout in U.K. history. Photographer: Jason Alden/Bloomberg

Philip Hampton is taking over as chairman of GlaxoSmithKline Plc as Chief Executive Officer Andrew Witty struggles to win back investors’ favor.

Witty, who’s led Britain’s largest drugmaker since 2008, is facing criticism for Glaxo’s lagging share performance and a depleted pipeline of promising medicines. A bribery scandal in China that led to a $489 million fine last year and sluggish U.S. sales also eroded support.

“Mr. Witty is running out of time,” said Stephen Bailey, a fund manager at Liontrust Asset Management Plc in London, which holds Glaxo shares. “He’s either got to deliver in the next 12 months or step aside.”

Hampton, 61, previously led the board of Royal Bank of Scotland Group Plc, where he presided over some 90,000 job cuts and a partial dismantling of the firm following the U.K.’s biggest bank bailout. Before that, he oversaw a turnaround as chairman of retailer J Sainsbury Plc.

He replaces Christopher Gent as Glaxo’s chairman on Thursday, a day after the company reports first-quarter results and holds a meeting for investors. Both Hampton and Witty declined to be interviewed through Glaxo’s press office.

Glaxo is trailing its 11 biggest rivals in annual revenue growth, data compiled by Bloomberg show. Its stock sank 7 percent in the past year, compared with a 30 percent increase in the Bloomberg Europe Pharmaceuticals Index. Only about a quarter of analysts rate Glaxo a buy.

Building Value

Hampton joins as Witty, 50, is undertaking the biggest reorganization since the merger that created Glaxo 15 years ago. He sold its cancer drugs to Novartis AG in exchange for the Swiss firm’s vaccines business and cash. The companies also formed a joint venture, controlled by Glaxo, to sell consumer health products.

The deals bring more predictable revenue and lessen Glaxo’s dependence on patented drugs, where sales suffer when generic substitutes reach the market. They also turn the London-based giant away from drug development at a time when investors are embracing it, said Bailey. “That’s where you can add value and build value,” he added.
GlaxoSmithKline Plc CEO Andrew Witty

GlaxoSmithKline Plc Chief Executive Officer Andrew Witty. Under Witty, Glaxo settled a marketing probe in the U.S. by paying a $3 billion fine in 2011, and a bribery investigation in China that concluded last year with a $489 million penalty.

Hampton will have to evaluate the performance of Witty and other senior executives, as any new chairman would, and won’t act rashly, said Justin King, who served as CEO of Sainsbury during Hampton’s tenure as chairman.
Pragmatic Approach

He’ll also have to recruit directors at Glaxo, where at least three will leave in the next 18 months. At Edinburgh – based RBS, where he served as chairman starting in 2009, Hampton revamped the board after nine members left in his first year.

In interviews with three board members and executives who worked with Hampton at Sainsbury and RBS, he was described as inquisitive, pragmatic, and down to earth.

“He’s not the slightest bit interested in the trappings of office,” King said. It’s no coincidence Hampton finds himself running companies in trouble, he added. “He has the appetite for challenge — he’s not a sinecure kind of guy.”

Hampton should reinvest in research at Glaxo, which is failing to produce drugs capable of boosting earnings, said Laura Foll, a fund manager at Henderson Global Investors Ltd. in London, which owns about 7.6 million shares in Glaxo.
Chart: Glaxo’s Bleak Prognosis

Profits are still tied to the aging asthma drug, Advair, while demand for two new respiratory medicines, Breo and Anoro, remains sluggish. The company is considering a spinoff of its HIV medicines, although it has few compounds capable of replacing them. Foll recommends cutting the dividend to fund research, a move some investors might resist.
Leading Change

Glaxo paid out 3.8 billion pounds ($5.7 billion) to shareholders last year, the most among major pharma companies relative to their market capitalization. It also pledged to return 4 billion pounds in proceeds from the Novartis deal to shareholders.

Shares of Glaxo have recovered some ground after the worst annual performance in more than a decade in 2014. The stock rose 10 percent so far this year after sales in the U.S. stabilized and the company in December announced 900 job cuts in North Carolina as part of 1 billion pounds in cost reductions.

Even so, Hampton’s appointment should be the catalyst for a re-examination of strategy, Foll said.

“There needs to be some sort of change — whether that’s under a new management team or not,” she said. “Phil Hampton may be able to lead the change from the top.”

http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11456163/Rainmaker-A-new-chairman-may-help-sugar-the-pills-for-GSK.html

When Sir Philip Hampton was named as the new chairman at GlaxoSmithKline, investors breathed a sigh of relief. After last year’s annus horribilis they wanted a fresh pair of hands to steer Britain’s biggest drug manufacturer.

Having had a seat at boardrooms including Sainsbury’s, Lloyds, British Gas, BT and latterly the Royal Bank of Scotland, Hampton is donning a white coat to tour GSK’s laboratories in an attempt to learn about the sprawling company.

He will start in May with a lot on his plate. Last year, GSK was fined a record £297m by Chinese authorities for its part in a huge bribery scandal. Hampton’s experience of highly regulated industries will no doubt help navigate the groups’ reputational challenges in Asia, but there are potentially even bigger issues lurking.

A boardroom shake-up might be a first course of business, industry sources suggest. Board members Tom de Swaan and Jing Ulrich have already signalled they are stepping down.

But questions are beginning to be asked of the chief executive, Andrew Witty, who has been at the helm throughout the slowing sales and bribery controversies.

Witty has resisted calls to stand down and instead agreed to take a bonus cut two years running. But there are growing suggestions that he is on borrowed time.

Sources believe that while he is a dynamic character, and has overseen some impressive deals including the $20bn (£13bn) asset-swap with Novartis, there aren’t many rabbits left for him to pull out of the hat.

GSK investigating alleged corruption in Iraqi division (RTE News/Telegraph UK April 7th 2014)


http://www.rte.ie/news/business/2014/0407/607262-gsk-iraq-probe/

GSK investigating alleged corruption in Iraqi division

Monday 07 April 2014 12.53

Staff at the pharmaceutical company's Chinese division are already accused of bribery offences
Staff at the pharmaceutical company’s Chinese division are already accused of bribery offences

British drugmaker GlaxoSmithKline is investigating alleged corruption by staff at its pharmaceuticals division in Iraq, the group has announced.

GSK, which already faces a bribery probe in China, stressed that it would not tolerate illegal behaviour by staff.

“We are investigating allegations of improper conduct in our Iraq business. We have zero tolerance for unethical or illegal behaviour,” a spokesman told AFP.

London-listed GSK employs fewer than 60 people in its pharmaceuticals operation in Iraq, while the allegations relate to a “small number” of individuals, he added.

“However, we are investigating whether there has been any improper conduct and these investigations are ongoing.”

The Wall Street Journal had reported that a person familiar with GSK’s Middle Eastern operations had emailed the drugs firm to report alleged misconduct and corrupt practices in Iraq dating from 2012 and 2013.

The spokesman added that GSK remained committed to improve healthcare in emerging nations like Iraq.

“Operating in emerging markets is challenging given the issues many of these countries face with funding and maturity of their respective healthcare systems,” he said.

“However, we continue to believe that with robust compliance systems and, by working closely with local governments, our presence in these markets can help improve access to medicines and broader healthcare.”

GSK is currently in the process of overhauling how it markets and sells products around the world, he added.

“We … continue to make fundamental reforms to our sales and marketing practices.

“Following successful roll out in the USA, we are globally changing how our sales representatives are paid and we are also stopping the practice of paying doctors to speak on our behalf.

“We believe these changes will eliminate any perception of conflict of interest and ensure incentives for our employees are aligned with the best interests of patients.”

On Friday, GSK revealed that it had dismissed a small number of workers at its Chinese division as part of the routine monitoring of travel expenses.

However, the move was not linked to Beijing’s ongoing bribery probe, the spokesman said.

In July 2013, GSK admitted that senior employees at its China business appeared to have breached Chinese law, after authorities alleged that employees had bribed government officials, pharmaceutical industry groups, hospitals and doctors to promote sales.

http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10749796/GSK-investigates-bribery-claims-in-Iraq.html

GSK investigates bribery claims in Iraq

British drugmaker, already embroiled in corruption scandal in China, looking into allegations against its Iraqi unit

A GlaxoSmithKline logo

GSK employs fewer than 60 people in its pharmaceuticals operation in Iraq and company spokesman says allegations relate to a small number of individuals in the country Photo: Getty Images

GlaxoSmithKline is investigating allegations of corruption against the company’s Iraqi arm, just nine months after becoming embroiled in a major bribery scandal in China.

The British drug giant is looking into claims the company hired government-employed doctors and pharmacists in Iraq as paid sales representatives, to boost sales of its products.

GSK launched the inquiry as soon as it was made aware of the allegations a number of weeks ago, the Telegraph understands.

“We are investigating allegations of improper conduct in our Iraq business. We have zero tolerance for unethical or illegal behaviour,” said a company spokesman.

He also said GSK employed fewer than 60 people in its pharmaceuticals operation in Iraq and that allegations relate to a small number of people in the country.

Glaxo received the allegations from a whistleblower who was familiar with GSK’s Middle East operation, according to the Wall Street Journal, citing emails from this person.

The whistleblower accused Glaxo of hiring 16 government-employed doctors and pharmacists as sales representatives for the company.

The person also claimed the practices make GSK vulnerable to prosecution under the UK Bribery Act and the US Foreign Corrupt Practices Act.

GSK is also facing allegations that sales staff in China paid as much as £320m in bribes to win market share.

The company has admitted that its own investigation into the allegations, made last year, unearthed evidence of wrongdoing by a handful of sales staff, but maintains they worked outside GSK’s control systems. It has called the allegations “shameful” and said it is cooperating with the ongoing Chinese investigation. The scandal has hit sales of GSK products in China, where it makes around 3pc of global revenues.

Despite GSK’s compliance problems in emerging economies, it continues to see these markets as crucial for the business. Last week it unveiled a $200m (£120m) investment in sub-Saharan Africa.

“We continue to believe that with robust compliance systems and, by working closely with local governments, our presence in these markets can help improve access to medicines and broader healthcare,” said a company spokesman.

Man dies after incident at GSK Waterford pharmaceutical plant


http://www.thejournal.ie/man-dies-incident-1279704-Jan2014/

Man dies after incident at Waterford pharmaceutical plant

The man at first thought to be a worker was actually a member of the public.

2 hours ago 23,076 Views  9 Comments

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Image: Lewis Whyld/PA Wire

AN INVESTIGATION IS underway after a man died following an incident on the grounds of the GlaxoSmithKline plant in Dungarvan, Co. Waterford this afternoon.

The death was at first believed to be the result of a workplace accident at the pharmaceutical plant but it has since been confirmed that the man was a member of the public.

The incident happened about 3pm this afternoon with the man subsequently taken to Waterford Regional Hospital by ambulance where he was subsequently pronounced dead.

A spokesperson for GSK said that gardaí had attended the scene and that the Health and Safety Authority has been notified.

The incident is currently under investigation and the company has extended its sympathies to the family of the deceased.

GSK Bribery Allegations Continue


http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10424869/GSK-likely-to-avoid-company-wide-bribery-charge-in-China.html

GSK likely to avoid company-wide bribery charge in China

Chinese executives at GlaxoSmithKline set to face charges over bribery allegations – but company itself and British staff to avoid charges

Photo: Reuters

By Denise Roland, and Reuters

12:07PM GMT 04 Nov 2013

Comments1 Comment

GlaxoSmithKline, the British drug company at the heart of a bribery investigation in China, is likely to avoid a company-wide charge for allegedly funnelling up to £300m in kickbacks to doctors and government officials.

Instead, police are likely to charge some of its Chinese executives, according to reports citing legal and industry sources. Such an outcome would see Chinese police drop claims made in September that corruption was co-ordinated at a company level.

In avoiding a corporate charge, GSK is far less likely to face investigations under the US and UK’s tough bribery laws, which could have resulted in major fines and even disruption to its operations in China.

Police are also unlikely to lay criminal charges against Briton Mark Reilly, GSK’s former head of China operations, it is understood.

Mr Reilly is understood to be under a travel ban in China after voluntarily returning to assist authorities investigating the bribery claims, which allegedly date back to 2007.

The accusations are the most serious made against a multinational in China in years. GSK’s sales in China, one of its most important emerging markets, dived 61pc in the third quarter after hospital staff shunned visits by its sales teams in the wake of the probe.

The investigation has coincided with stepped-up Chinese scrutiny of how foreign firms do business in the world’s second biggest economy, with the spotlight especially on graft and pricing in the pharmaceutical and infant milk formula markets.

The police investigation into GSK is likely to be concluded around the end of November or in December, said a person with direct knowledge of the probe.

The sources noted it was difficult to predict what Chinese authorities would ultimately do.

But the most likely legal scenario was that they would charge Chinese GSK executives, said the person with direct knowledge of the investigation and two other sources familiar with the matter. The sources declined to be identified because of the sensitivity of the case.

Indeed, the Ministry of Public Security had tried to find evidence tying GSK as a legal entity to the alleged wrongdoing, but it was unlikely authorities would be able to prove its involvement at a corporate level, said the person with direct knowledge of the investigation.

“There will likely be big fines, but it’s unlikely GSK will be thrown out of the country,” the person said.

The Ministry of Public Security, which is spearheading the investigation, did not respond to requests for comment.

GSK has said some of its senior Chinese executives appear to have broken the law. It has also said it has zero tolerance for bribery, calling the allegations in China “shameful”.

“The investigation is ongoing and we are fully cooperating with the authorities. The investigation is subject to Chinese law and GSK respects this. As such, we are unable to comment further at this stage,” said a spokesman for GSK.

Lawyers said it would be extremely rare for the Chinese government to pursue a criminal case against a foreign company, but if one was charged, the result would likely be significant fines and disruption to its operations in China.

The State Administration of Industry and Commerce (SAIC) issues all firms in China a business license, which under extreme circumstances can be revoked.

“It would be unprecedented frankly. I don’t know any previous case in which the Chinese government has laid criminal charges against a foreign company,” said Daniel Chow, professor of law at Ohio State University.

Four executives from mining giant Rio Tinto were jailed in March 2010 for taking bribes and stealing commercial secrets in the most serious previous case against a multinational firm. The company was never charged.

Individuals found guilty of serious bribery can face 10 years to life in prison, according to China’s criminal code. A voluntarily confession can result in a sentence reduction.

If allegations of bribery are not found to be criminal but administrative in nature, authorities can fine individuals up to Rmb200,000.

Under Chinese law, action may be also be taken against managers with responsibility over a region or sector, although lawyers said this would also be unusual.

“For senior management to be charged you have to prove that this person has awareness or knowledge of the criminal act, or at least should have known but did not exercise his duty of care,” said the second source, a China-based lawyer with knowledge of the investigation.

“I’m not sure the government has the evidence supporting these allegations.”

Lawyers said any fines levied against GSK would depend on the severity of the charges against its executives.

___________________________________________________________________________

GSK’s Extensive and Long History of Corporate Misconduct… Bob Fiddaman Investigates..


And this is just the tip of the iceberg where GSK and bad deeds are concerned… 
Scary..

http://fiddaman.blogspot.ie/2013/09/gsk-runaway-trainrunning-right-off-track.html

Saturday, September 14, 2013

GSK – A Runaway Train…Running Right Off The Track

If there is one corporate company still operating when it really shouldn’t be that company that stands head and shoulders above any other I know is British based GlaxoSmithKline.No sooner had they been found guilty for a whole host of violations in the US [Resulting in an estimated $3 billion fine] they are back in the news again for yet more violations, this time in China.The Chinese violations are currently under investigation. GSK head honcho, Andrew Witty, has denied knowing about the shenanigans going on in China which include:

  • Bribing doctors with cash payments
  • Bribing doctors with sexual favours
  • Using a network of more than 700 middlemen and travel agencies
  • Inventing meetings that required travel payments (these payments were given to doctors to persuade them to prescribe GSK products)
Glaxo’s $3 billion fine in the US is just another piece of the jigsaw. Before this they have made settlements in and out of US Courts, paying defendants compensation and slamming down gagging orders as part of the settlements… in other words nobody can go public with amounts paid to them.
Let’s just take a look at some of the other violations committed by GlaxoSmithKline over the past few years.
Cidra
Glaxo’s Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company’s sale of Paxil (Seroxat) and Paxil CR.
A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo’s Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004
Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra… they didn’t.
After leading her recovery team Eckard found more violations that the FDA had missed first time round.
In a nutshell, she brought this to the attention of her senior managers, her managers ignored her… then fired her.
According to Eckard’s complaint: “persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. … rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for “black market” packaging and distribution …”
 
Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it’s committed to continuously improvingmanufacturing quality. The company denied Ms. Eckard’s allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.
Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.
No criminal charges were laid against Glaxo despite allegations of their involvement in selling on rejected batches of drugs to MOVA Pharmaceuticals.
Avandia
Glaxo suppressed patient-level meta-analysis of safety data from Avandia trials which demonstrated an estimate of excess risk of ischemic cardiovascular events and other potentially life-threatening complications.
A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication.
During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.
In 2012, after being ordered to pay $90 million to resolve allegations by prosecutors in 38 states that the they illegally marketed Avandia, Glaxo had this to say:
 “The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement” 
 
 
Paxil (Seroxat) Birth Defects
 
After deliberating for seven hours, a state court jury in Philadelphia found that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.
The case was the first to go to trial of more than 600 suits claiming that Glaxo hid knowledge of birth defect risks allegedly tied to Paxil.
What did Glaxo have to say after being found guilty?
“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.” 
You’ll probably find that the jury thought otherwise Glaxo.
Paxil (Seroxat) Suicide
On December 14, 2009, Bloomberg published an article entitled “Glaxo Said to Have Paid $1 Billion in Paxil Suits.” 
The article reported:
GlaxoSmithKline PLC has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
Why did they do this?
Well, it’s down to the Schell case in 2001.
Donald Schell, 60, had been taking Paxil for just two days when he shot and killed his wife, his daughter, his granddaughter and then himself.
Remaining members of the family filed suit.
During the trial GSK [then SmithKline Beecham] internal documents showed the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging didn’t, at the time, include a warning about suicide, violence or aggression.
Glaxo were found guilty and ordered to pay $6.4 to the remaining family members.
What did Glaxo attorneys say after this particular defeat?
“Paxil is a very effective medication in helping depression,” attorney Charles Preuss said after the trial. “Our only regret is that Mr. Schell did not have Paxil for a longer period of time.” [Link]
 
The link between Paxil and suicide has been raging for years.
Here’s what former Head of Psychiatry at GlaxoSmithKline, Alistair Benbow, had to say in a BBC interview.
Benbow {A} was being interviewed by investigative journalist Shelley Jofre.{Q}
Q. Let us move on. What has the company done about the Wyoming (Schell) verdict?
A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed…
Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.
A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.
Again, I think the jury would disagree with Benbow here.
If Glaxo believed their product was innocent in the suicides of these people why would they settle further cases? One such case involving the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.
They then settled with the family later.
Paxil (Seroxat) Addiction
In its 2008 annual report, Glaxo officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.
In other words a gagging order was place. This enables Glaxo to defend any further lawsuits regarding Paxil addiction. One such lawsuit is the UK Seroxat litigation which Glaxo are defending.
The UK lawsuit has been dragging on for over 10 years now. Glaxo have refused to make any such compensatory settlements to any UK citizen.
So, just a few reasons why it comes as no surprise to learn that Glaxo have been behaving badly in China. No surprise that Witty is denying any knowledge of what went on in China either.
Even when found guilty Glaxo continue to deny any wrong-doing… that trend will continue until compensation is put to one side and criminal charges are laid against the top executives at Glaxo. They are the past masters of buck-passing, of laying blame on others, of waving wads of cash [dangling carrots] in front of victims in the hope that a settlement can be reached. With settlement comes suppression and Glaxo just love suppression.
I anticipate that the bad behaviour in China will be settled and those responsible [the top management] will deny knowledge and let the area managers take the fall.
That’s their style, always will be until someone has the balls to come down hard on the senior management at GlaxoSmithKline.
Someone really needs to put a stop to this runaway train.
Bob Fiddaman

GSK “Saves The Children” (Apart from the one’s dead and damaged from Seroxat!)


http://www.guardian.co.uk/commentisfree/2013/may/10/gsk-save-the-children-aids-drugs-africa

Charity and Big Pharma make uneasy bedfellows

The alliance between GlaxoSmithKline and Save the Children is a pragmatic one that will do good. But is it the best way forward?

andrew witty gsk

Andrew Witty on a visit to Katine … he has said that GSK must do what it can to improve the health of people in poor countries. Photograph: Martin Godwin for the Guardian

Development charities and multinational drug giants have not always appeared obvious bedfellows. The International Aids Conference that takes place every two years – last year in Washington DC – used to be famous for the trashing of drug company stands by activists who had at least the sympathy of mainstream charities. Red paint, for the blood of those who could not afford the price of drugs to keep them alive, flowed in the halls.

So the union of Save the Children and GlaxoSmithKline, launched yesterday in Kenya, is something of a landmark moment. It raises questions about Big Pharma and about the future direction of NGOs and development as a whole. And it has left a number of people working in aid feeling very uncomfortable.

Save the Children and GSK talk of the five-year partnership as a groundbreaking new deal. GSK will reformulate products and develop others in line with Save the Children’s advice on what poor countries really need to save babies’ lives, while helping to train healthworkers. GSK’s chief executive, Sir Andrew Witty, says it is all about speeding things up. From the realisation that babies die for lack of antibiotics to making available a dose-sized pack of powder that families in Africa can use (if they have clean water) takes too long. Witty wants to cut through grindingly slow bureaucratic processes. If he says “jump” in GSK’s west London or Philadelphia corporate HQs, people jump. Things get done. That’s what they are paid for.

Witty and Save’s chief executive, Justin Forsyth, have been moving towards this union for some time. Witty has declared that his company must do what it can to improve the health of people in poor countries. Since 2009, he has made a series of moves, from cutting the prices of GSK’s drugs in the poorest countries to reinvesting 20% of the profits they make locally. This is, he says, another step on that road.

Forsyth is a mover and shaker, who arrived to head Save the Children from Downing Street, where he was director of strategic communications for Gordon Brown, having previously worked for Tony Blair. He ran the communications strategy for the London G20 summit. He is another man who believes in getting things done. For Save, this is a pragmatic move. Money is short in development and getting shorter as the economic situation does not improve. Increasing amounts of the Department for International Development’s funding look likely to be spent on what used to be called defence. All aid organisations are looking for more help. Big Pharma has shedloads of cash. GSK made nearly $9bn in profits in 2011.

But does the link-up of GSK and Save wash away the sins of Big Pharma? It will do GSK’s reputation no harm at all, but it won’t stop the criticism. It was muted yesterday, because NGOs do not want to throw mud at each other, but there were plenty who did not feel like throwing confetti. If GSK really wants to do good, says Médecins Sans Frontières, it should pledge truly low prices for all its HIV drugs in the developing world.

Health Action International is blunter. It fears an agenda set in London, a programme of good works that will run in parallel with the domestic policies of the governments of Kenya and the Democratic Republic of Congo (DRC) and risk undermining them. “Has anyone consulted, and really found out, what is required or is this initiative driven by the needs of CSR [corporate social responsibility], and, it has to be said, an organisation that, like us all, is looking for funds in the face of economic crisis?” asked Dr Tim Reed, its executive director.

The partners aim to save the lives of a million babies. It’s hard to argue with that. And it’s a safe bet they will. But the debate over whether this is the best way to do it will run and run.

Morals Versus Profits? : With GSK… Profits Always Win…


“Irony is wasted on the stupid”  (Oscar Wilde)

Interesting to see Seroxat back in the news of late- this time though not because of its propensity to cause suicide, homicide, birth defects or withdrawal- but because apparently GSK are being accused of an illegal ‘pay to delay’ deal with their generic rivals going back to the early 2000’s.

What makes this interesting is the response from GSK CEO – Sir Andrew Witty- his comments about this latest accusation in relation to GSK’s notorious Seroxat drug are subtle but loaded…

You will notice that Andrew Witty fails to really deny that GSK did a ‘pay for delay deal’- but he implies that the headlines on this scandal have been ‘misleading‘. I think for a drug company which has consistently misled its patients, share-holders, regulators, governments and practically every stakeholder related to it for the past 20 years- to use the word ‘misleading’ in any context is an irony that Oscar Wilde would surely appreciate…

http://www.philly.com/philly/blogs/phillypharma/With-Supreme-Court-weighing-a-case-GSKs-Andrew-Witty-says-pay-to-delay-label-misleading-defends-such-settlements.html

With Supreme Court weighing a case, GSK’s

Andrew Witty says ‘pay-to-delay’ label

misleading, defends such settlements

POSTED: Wednesday, April 24, 2013, 2:48 PM
David Sell
GlaxoSmithKline CEO Andrew Witty at new office in the Navy Yard. March 21, 2013. ( AKIRA SUWA / Staff Photographer )

As drugmaker GlaxoSmithKline reported 25 percent lower, after-tax profits in the first quarter of 2013 compared to a year earlier, chief executive officer Andrew Witty said Wednesday that the company would reorganize its pharmaceutical operations, opening the potential of sale of older brands.

Glaxo is based in London, but has about 1300 employees in Philadelphia’s Navy Yard and more in other facilities in Pennsylvania and New Jersey.

Meanwhile, with UK authorities criticizing GSK for trying to delay the introduction of generic competitors nearly 10 years ago and the U.S. Supreme Court weighing a case, Witty defended the business practice.

The UK’s Office of Fair Trading alleged on April 19 that GSK had abused its dominant position in the UK to delay the introduction of generic medicine by paying off three generic drug companies. GSK said the allegations stemmed from activity between 2001 and 2004, that it was cooperating with the investigation, but thought it had acted within British law.

In many countries, patents on drugs give manufacturers exclusivity in the marketplace, allowing them to charge more for a drug.

In the United States, branded and generic companies have had made such deals for nearly 30 years, and they are called reverse payments or pay-to-delay deals. Basically, the generic company applies to the FDA for approval of a drug that it says is close to a copy of the branded product, but not so close as to infringe on the patent. The branded company sues, claiming patent infringement. Sometimes they settle the suit, with the generic drugmaker able to sell its version earlier than it would have if it waited for the patent to expire.

But sometimes those settlements are made with the branded company paying the generic company, and that prompted the U.S. Federal Trade Commission to object. The FTC argues that the growing number of deals involving payment restrict trade and hurt consumers and taxpayers.

The U.S. Supreme Court heard arguments on March 25 and will likely decide whether such deals are legitimate by the end of its term in June.

When asked by the Inquirer about the practice, Witty declined to discuss specific cases, but he defended the general practice.

“I push back at the description of ‘pay-to-delay’ as a label,” Witty said from London in a conference call with reporters. “It is a convenient label that people have chosen to use. But in many situations – and I’m talking generically here and not specifically about any particular case – there has been a settlement between the patent holder and a non-patent holder, which usually leads to the generic product being made available before the expiration date of the patent. What is achieved in that is the elimination of uncertainty for both sides.

“The patent holder has a patent. The challenger wants to challenge that patent. But neither side knows what the outcome of that [litigation] is going to be – other than it is going to be a difficult process and expensive. As a consequence, sometimes settlements make sense for parties concerned. But almost always, those settlements lead to the generic being made available earlier than waiting for the patent to expire. Within that, I think it is entirely reasonable that the patent holder should be able to come to settlement to take away the uncertainty. Presumably, the challenger would only enter into such a settlement if it also made sense for them, for the mirror image reason, ie., they don’t have certainty either. Every case is different and every challenge is different. But I would push back on this, I think, misleading label.”

As for the reorganization inside the pharmaceutical division of the company, Witty said GSK will shift about 50 “legacy” prescription medicines that are promoted lightly, if at all, into one category and that group’s finances would be reported separately starting in January of 2014. This group of products will be called “Established Products.”

Glaxo has a consumer segment that sells such things as toothpaste and denture products. But the other two pharmaceutical groups would be one that deals with products currently on the market and receiving promotional resources, with the second being products in the pipeline but not yet approved or launched. Glaxo has submitted six drugs for approval by the U.S. Food and Drug Administration and the European Medicines Agency.

Witty said the established products – such as Zantac, Imitrex and Zofran – amount to about $4.5 billion in revenue, and he was asked if it signaled an intent to sell those products.

“How it might play forward beyond that is an open question,” Witty said. “It is a sensible move for us to make sure we are maximizing value in the short run. But, of course, it opens optionality for the future. I would not give any guidance on how or when that might evolve, but it opens some optionality.”

Glaxo had $9.9 billion in sales in the first quarter, which was a drop from $10.1 billion in the same period in 2012.

The after-tax profit for the first quarter of 2013 was $1.57 billion, which compared to $2.1 billion for the same period in 2012. One factor in the difference in profit was that in January of 2012, GSK reported the $660 million sale of some of its over-the-counter brands to Prestige Brands Holdings, Inc.

Witty said Wednesday, as he has done in the past, that he has no plans for GSK to enter the generic drug market.

“There is absolutely no interest in going into the generics business,” Witty said. “That is a long-held view of mine and that view has not changed.”

A link to the quarterly financial report is here.

Here are some articles pertaining to how GSK have consistently been accused of ‘misleading’ the public..

GSK misled over Serevent data?

October 10, 2005
| PharmaTimes

GlaxoSmithKline is in the firing line again after a letter published in The Lancet accused the firm of misleading regulators over clinical data for its asthma compound, Serevent (salmeterol), which is also an active ingredient in its multi-billion dollar offering Advair (salmeterol/fluticasone). However, the news has been strongly combated in a responding article from the UK drug giant. Public Citizen, the US consumer group, said a 1996 trial – the Salmeterol Multicenter Asthma Research Trial – showed an increased risk of asthma death amongst patients taking GSK’s drug. These results have never been published, it says, despite interim results being presented to the US Food and Drug Administration in July 2003 at a review by the agency’s advisory committee. Final study data were submitted to the FDA on August 29, 2003, but included adverse event observations reported six months after the 28-day trial ended, which Public Citizen claims went against the trial’s protocol: “The inclusion of the post-study data reduced the apparent dangers of salmeterol with respect to four critical study outcomes, including asthma-related death.” The FDA questioned the results in 2004, and in July its advisory board recommended strengthening the warning labels for both Serevent and Advair to caution about the risk of asthma-related death [[14/07/05a]]. However, the agency has yet to make its final decision. “The behavior of GlaxoSmithKline in submitting these faulty data is deplorable,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group and co-author of the letter. Without “greater transparency at the FDA, we will never know how often this kind of self-serving data analysis occurs.” However, in a hard-hitting response to Dr Lurie, the company said: “GSK has acted responsibly and transparently and communicated with a sense of urgency to ensure that healthcare professionals and patients had access to the results of SMART.” It argued that the protocol did specify both the collection of reported events during the 28-week study period and during a 6-month follow-up. The results, it stresses, were disseminated in a variety of means: the company said it issued two ‘Dear Healthcare Professional’ letters, posted notices on its website and that of the FDA, presented the results at a medical meeting in 2003, and included the information in its online clinical trial registry. However, GSK will likely be unhappy at being back in the spotlight again as it was questions over its antidepressant, Paxil/Seroxat (paroxetine), that led to the global move towards making clinical trial data – both positive and negative – publicly available [[03/06/04a]], [[17/06/04b]].

http://www.pharmatimes.com/mobile/05-10-10/GSK_misled_over_Serevent_data.aspx

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Home » Pharmalot » UK Funds: Glaxo Misled On Avandia Risks

UK Funds: Glaxo Misled On Avandia Risks

Posted Sat, 09/15/2007 – 9:08am by Ed Silverman 0
jp-garnier.jpgJust one more example of investor dissatisfaction with JP Garnier. The North Yorkshire Pension Fund and the Avon Pension Fun, which together manage more than $6 billion in assets, are vying to be lead plaintiffs in a US class-action lawsuit filed against the drugmaker for misleading investors over the risks of its Avandia diabetes pill.

The lawsuit seeks unspecified damages related to a slide in the group’s share price that followed a study published in May in the New England Journal of Medicine claiming that Avandia raised the risk of heart attack by 42 per cent. The findings, denied by GSK, wiped about $18 billion off its market capitalisation.

The two UK funds claim they lost roughly $5 million. “We are joining [the lawsuit] because it is in our members’ interests to do so,” Neil Sellstrom, of the North Yorkshire fund, tells The Times of London.

The lawsuit alleges Glaxo “engaged in a scheme to deceive the market and a course of conduct that artificially inflated GSK’s stock price” and “failed to adequately disclose” important risk info. Glaxo is accused of “fraud” and “deceit.” A spokesman for GSK said that the company believed the lawsuit had no merit and would vigorously defend itself.

Glaxo investors are increasingly unhappy with the drugmaker’s share price and some are agitating for Garnier to sell off various pieces, such as the consumer healthcare business or vaccines research. For his part, the indefatigable Garner refuses to consider such moves and last week brushed aside the criticism.

Garnier, however, continues to suffer setbacks. At week’s end, the FDA further delayed approval of Entereg, an experimental constipation med that’s being developed by Glaxo’s partner, Adolor. The agency previously issued an approvable letter back in June, which itself was a disappointment.

http://www.pharmalive.com/uk-funds-glaxo-misled-avandia-risks

Professor says GSK knowingly mislead about Paxil safety

Jon Jueridini, a professor of psychiatry at the University of Adelaide in Australia, recently authored an article claiming that the pharmaceutical company GlaxoSmithKline seriously misrepresented safety and effectiveness data when publishing information about its antidepressant Paxil, also known as paroxetine. GSK was previously known as SmithKline Beecham, and is currently involved in ongoing Paxil litigation over birth defects.

In an article for the Website “The Conversation,” Jueridini details information that he came across while examining internal documents as an expert witness in a case against a pharmaceutical company.

Between 1993 and 1998, he writes, GSK paid $5 million for research into Paxil.

Researchers subsequently published the results in the Journal of the American Academy of Child & Adolescent Psychiatry in 2001, asserting that Paxil “is generally well tolerated and effective for major depression in adolescents.”

Jueridini characterizes this as a “serious misrepresentation of both the effectiveness and safety of the drug.” Children on Paxil did no better than those on placebo in the studies, Juerdini writes, but the company misrepresented or flat-out omitted any negative findings in the published results.

Other alarming information has since come to light concerning Paxil and other antidepressants classified as selective serotonin reuptake inhibitors, or SSRIs. In July of 2007, the New England Journal of Medicine published a study by the federal Centers for Disease Control and Prevention that showed babies born to mothers who took SSRIs such as Paxil, Prozac, and Zoloft during the second half of pregnancy had a significantly increased risk of being born with birth defects, including serious respiratory disorders.

See the article here: https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071

Related posts:

GSK Paxil settlement has lessons for consumers
Study questions safety of antidepressants
GSK CEO addresses company’s fraud allegations
Paxil manufacturer paying record settlement for fraud
Book takes critical look at antidepressant marketing
Unpublished studies distort assessment of treatments
Article questions psychiatry’s reliance on drugs
Psychologist believes antidepressants overprescribed

http://www.lopezmchugh.com/2012/04/21/professor-says-gsk-knowingly-mislead-about-paxil-safety