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Posts Tagged ‘Avandia’

GSK gives in – Last-minute deal in Avandia suit

Posted by shutah on January 31, 2011

A federal court in Philadelphia was all set to hear a liability lawsuit against GlaxoSmithKline today, but an 11th-hour settlement took that case right off the docket. GSK made a deal with the family of Avandia patient James Burford to resolve claims that the diabetes drug caused his fatal heart attack. GSK recently took a $3.5 billion charge for legal expenses, including new Avandia litigation filed in the U.S.

The settlement lets GSK avoid the risk of a jury trial, Matrix Corporate Capital analyst Navid Malik told Bloomberg. Investors had worried that a trial “could lead to substantial punitive damages,” Malik said. “GSK needs to successfully settle as many of these cases as possible.”

Two other suits brought by the same plaintiff attorneys were also settled. “GSK has resolved the Burford case scheduled for trial today in the U.S. District Court in Philadelphia, and all cases represented by attorneys Joseph Zonies and Thomas Cartmell,” GSK said in a statement, which also emphasizes that, “GSK continues to stand behind the safety and efficacy of Avandia when used appropriately and according to its label.”

Avandia’s safety, particularly its potential link to heart attack risks, has been under debate for several years, and GSK has already resolved some 10,000 liability suits with a $460 million settlement. In September, European regulators banned Avandia, saying its risks outweighed its benefits. The FDA stopped short of withdrawing the drug, but sharply restricted its use, and GSK agreed to stop promoting it. About 2,000 more lawsuits remain outstanding.

This SUCKS!!!  Not for the Claimants, I’m thrilled for them.  But GSK have ‘settled’ the case, thereby allowing them to walk away from their responsibilities by not having to testify in Court.

Their statement … “GSK continues to stand behind the safety and efficacy of Avandia ….” shows them to be lily-livered, cold-hearted bureaucrats with a seemingly bottomless well of money to throw about.  I’ll bet GSK doesn’t have the balls to ‘fess up to their errors when it comes to the SSRI drugs they ‘peddle’ around the World!!!  Boo, Hiss GSK!!!!


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Glaxo Avandia Settlement [latest news]

Posted by shutah on January 25, 2011

Oh Dear!!  GSK in the spotlight a lot this week.

Reports said Monday thatGlaxoSmithKline is bound to face a multi-district litigation amounting to an estimated $3.4 billion against its anti-diabetes drug, Avandia.

According to the reports, a number of pending litigations against Avandia, an oral anti-diabetic agent which acts primarily by increasing insulin sensitivity, are filed in different states of America. Federal courts’ records show that more than 50,000 complaints were reported against the adverse effect of Avandia.

In 2010, Glaxo already settled an approximated 10,000 Avandia cases with an average settlement of $460 million. On Monday, another lawsuit was heard in the US District Court for the Eastern District of Pennslyvania. The lawsuit involves a claim filed by the relatives of James Buford, a diabetic patient who had been taking Avandia for 15 months, after the latter died of heart attack.

The incident proves a meta-analysis of 42 clinical studies, saying that daily intake of the anti-diabetes drug can relatively increase the risk of myocardial ischemic attack such as angina pectoris and myocardial infarction. Buford’slawyer argued that approximately three weeks after Buford started takingAvandia, the patient suffered symptoms that suggested a mild heart attack. Earlier this month, Glaxo announced that it was reserving $ 3.4 billion to cover the contingency loss brought by the Avandia lawsuits.

Meanwhile, a second trial against Avandia is scheduled to begin on March 28 this year, which involves a patient who allegedly used the drug and suffered congestive heart failure from Avandia. Experts said that Avandia has caused 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the United States from 1999 to 2006. Glaxo is currently under investigation by the US Department of Justice and several other state lawyers for potential fraud.

Wouldn’t it be great if the UK ‘Justice Department’ investigated Glaxo on behalf of all those, past and present, who suffer at the hands of their drug Seroxat/Paxil?

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GSK pulls ED ads to help rehab its image

Posted by shutah on January 25, 2011

Whoopy bloody dooooo!!!  Not before time that they [GSK] started to take some responsibility for their actions (inactions)!!!!

GlaxoSmithKline is pulling ads for its erectile dysfunction drug Levitra. And it’s making a big show of that choice; North American President Deirdre Connelly said it’s part of the company’s new push to be more transparent and operate with integrity. “When we walk into your home through television, we have to do it in a respectful way,” Connelly said to the Wall Street Journal.

Basically, Connelly lumped the Levitra ad move in with GSK’s ongoing campaign to break with the past, which has been sullied by off-label marketing allegations, whistleblower suits, safety questions and quality problems. And when GSK took a $3.4 billion charge for legal liabilities–including lawsuits over the recently restricted diabetes drug Avandia and a potential Justice Department settlement in an off-label marketing probe–some industry observers pegged the move as an attempt to start fresh. That charge came on top of last year’s $750 million manufacturing settlement, another longtime battle put to rest.

The company has done some other things aimed at the integrity target. It set up public databases of its payments to doctors and medical schools, and its educational and charitable grants. It changed the rules on funding continuing medical education. It just got rid of sales-related bonuses for reps, hoping that a broader job-performance focus will play well with patients and doctors–and perhaps to offset suspicions that could arise with an off-label marketing settlement. GSK has also cut prices in the developing world to give poor people easier access to medicines, a move CEO Andrew Witty has touted repeatedly. The message is clear–we’re doing business differently now.

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Glaxo Stung by Legal Bill

Posted by shutah on January 19, 2011

GSK shareholders are hit by costly legal settlements.

If big really is beautiful, then you don’t get much more attractive than pharmaceutical giantGlaxoSmithKline

Glaxo the global giant

By any measure, GSK is a powerhouse. The world’s fourth-largest drug-maker recorded annual sales of over £28 billion in 2009 and posted a post-tax profit of £5.7 billion. GSK employs nearly 100,000 people and paid over £2.2 billion in corporate taxes last year, so it’s one of the biggest corporate contributors to HM Treasury’s coffers.

Furthermore, with a market capitalisation of over £61 billion, the blue-chip firm’s shares are very widely held, featuring at the heart of many UK-focused portfolios, both private and institutional. So, when GSK stumbles, it has an impact on millions of investors.

A £2 billion setback

One such stumble happened earlier this week, after it was announced that GSK is to record a charge of £2.2 billion (or £1.8 billion after tax) due to additional legal costs incurred in 2010.

This legal charge relates largely to an ongoing US investigation into the sale and promotion of diabetes drug Avandia. Following concerns about raised cardiovascular risk among Avandia patients, the drug has been largely withdrawn from prescription in America and Europe. As you’d expect, this partial withdrawal has triggered a flurry of product-liability lawsuits, especially in the famously litigious US.

Legal side effects

Of course, this isn’t the first time that GSK has had to dig deep to meet big bills arising from legal disputes and regulatory fines. In the world of ‘Big Pharma,’ multi-billion-dollar settlements for product-liability cases are almost as common as the side-effects these drugs sometimes cause.

In common with other regulators, the US Food and Drug Administration (FDA) and the European Medicines Agency have become far more hands-on when enforcing pharmaceutical safety. Hence, recent years have seen a notable increase in the number of enforced product withdrawals, ‘black box’ safety warnings, and huge fines for regulatory breaches.

Indeed, in its last set of annual results, GSK had already set aside nearly £1.6 billion for legal charges covering Avandia and antidepressant Paxil. This sum also included £500 million stemming from manufacturing problems at a former GSK plant in Puerto Rico which was closed in 2009.

A bitter pill to swallow

In some pharmaceutical circles, such legal charges are seen as an almost inevitable price of launching blockbuster drugs into the lucrative US and European markets.

Obviously, GSK shareholders will welcome the company’s attempts to make proper reserves for new Avandia claims in the US. Then again, £2.2 billion before tax is a bitter pill to swallow, as this record-breaking charge will wipe out Glaxo’s fourth-quarter profit. What’s more, this charge is only a ‘reasonable estimate,’ so it could rise or fall in future.

Nevertheless, GSK’s shares closed at 1,182p on Tuesday, down almost 5% from the 1,240p they traded at before this surprise announcement. This represented a £3 billion drop in GSK’s market capitalisation.

Has Mr Market over-reacted?

Given that the drop in GSK’s value exceeds the expected loss by a wide margin, some investors will take the view that the market has over-reacted. On the other hand, critics will argue that announcing such a large loss provision out of the blue suggests that, at best, GSK needs to improve its communication. At worst, investors will fear reputational damage to the company from yet another run-in with the FDA.

Even so, on a price-earnings ratio of around 10 and a dividend yield above 5% (covered twice), GSK displays some well-worn value characteristics. In addition, the company has a rock-solid balance sheet and throws off cash in the billions.

However, this charge — approaching a quarter of 2010’s total profits — could spell an end to GSK’s aggressive share-buyback scheme, during which the company has retired hundreds of millions of shares. Likewise, lower cash reserves could lead GSK to trim its dividends, although I don’t expect this to happen. After all, GSK’s annual dividend climbed by 36% between 2001 and 2009 and rose in each of these years.

In my view, this legal setback, while non-trivial, is only a small part of the big picture. Far more important is GSK’s cost-cutting and its stated goal to move away from ‘white pills and western markets’. If these initiatives succeed by growing earnings, then we should see an upward re-rating of GSK shares.


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