GlaxoSmithKline’s 50,000 Avandia Lawsuits…


https://www.drugwatch.com/avandia/litigation/

Avandia Lawsuits and Settlements

Throughout the past decade, GlaxoSmithKline has faced 50,000 lawsuits over its Type 2 diabetes drug Avandia. The lawsuits often allege the drugmaker failed to disclose that the popular drug may significantly increase the risk of heart attack and heart-related death. The drug’s maker, GlaxoSmithKline, has set aside $3.4 billion to settle individuals’ lawsuits over the drug and has paid another $90 million to 37 states and the District of Columbia after Attorneys General sued the company over its marketing of Avandia.

*Please seek the advice of a medical professional before discontinuing the use of this drug…..”

https://medslawsuit.com/drug-injuries/avandia-lawsuit/


 

Interesting article (above) which mentions GSK’s 50,000 lawsuits over its heart-attack causing Diabetes drug- Avandia. Avandia has been dogged by controversy for a long time, however it’s interesting to see the figures in terms of lawsuits for drug damage because of it. I often wonder what the CEO’s of GSK (and the executives in general) think of these kinds of figures? Do they think that 50,000 people damaged is an acceptable number? Is it collateral damage to them? or do they not give a damn at all and barely give these things a second thought. Personally I think only a sociopath could ignore these kinds of things and collect the paycheck while people die or get harmed from defective dodgy drugs like Seroxat and Avandia.

50,000 lawsuits is a lot for one drug- however there has been similar numbers with GSK’s SSRI drug- Paxil/Seroxat, and other drugs such as Myodil, Pandemrix, Cervarix- etc – which have all been dogged by controversy and legal actions- some ongoing. Disturbingly too, 50,00 lawsuits is the tip of the iceberg in terms of damage – as many people cannot afford to bring pharmaceutical companies to court- or often times- they are dead from the drug so recourse is an impossibility.

How many people have GSK harmed, or killed, since its inception as a company over 100 years ago?

You won’t see that figure in their promotional brochures

And you certainly won’t hear the CEO’s talk about that either..

Publicly at least anyhow..

 

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GSK’s Avandia And The RICO Act (Racketeer Influenced and Corrupt Organizations)


pharmafia

An interesting GSK scandal brewing away at the minute is the Avandia scandal and the RICO Act 1970. The RICO Act was originally brought about to prosecute organized crime syndicates like the Mafia in the US therefore it is interesting (and wholly appropriate) that GSK should be prosecuted under it too. They are, after all- Global Serial Killers- and a Pharmafia- type- organization who have proven time and time again, over decades, to be nothing but utterly corrupt and fraudulent.

See RICO Act Avandia Suit here


http://www.biopharmadive.com/news/high-court-rules-glaxosmithkline-must-face-rico-suits-over-avandia/420476/

High court rules GlaxoSmithKline must face RICO suits over Avandia

Dive Brief:

  • The Supreme Court ruled Monday that GlaxoSmithKline must face lawsuits brought by three union health plans that said they overpaid for the diabetes pill Avandia.

  • The lawsuits claims GSK concealed the cardiovascular risks of Avandia to boost sales
  • The three union health funds are pursuing a claim under the RICO act, claiming GSK was engaged in an illegal conspiracy.

Dive Insight:

The suits, filed by three union health funds between 2007 and 2010, claim the plans paid more for prescriptions than they would if they knew of the risks. Avandia was hit with an FDA label warning in 2007, and with new restrictions in 2010, as reports surfaced of the cardiovascular risks.

The FDA lifted all its safety measures late last year, but the drug had fallen from $3 billion in annual sales to less than $200 million. The FDA subsequently took a fresh look at Avandia data and voted in 2013 to remove many of the restrictions it had placed on the drugs, saying the data did not show an increased cardioviscular risk over standard diabetes treatments.

Recommended Reading

Business Intelligence: U.S. top court rejects Glaxo bid to throw out racketeering lawsuits
Stat: Supreme Court says Glaxo must face racketeering suits over a diabetes pill

Action 9: Man waits years for money after $3 billion Avandia settlement


Updated: 7:51 p.m. Monday, Jan. 5, 2015 | Posted: 4:40 p.m. Monday, Jan. 5, 2015

Action 9: Man waits years for money after $3 billion Avandia settlement

Action 9: Man waits years for money after $3 billion Avandia settlement photo
Action 9: Man waits years for money after $3 billion Avandia settlement

By Jason Stoogenke

It was one of the biggest drug settlements in U.S. history.

The drug company paid all of the money. But, years later, one local man, Terry Tribble, says he still hasn’t seen a dime. 

“My God, what happens if I(die) while waiting on them to sign a paper and issue the money?”  Tribble said.

Glaxo SmithKline (GSK) agreed to pay more than $3 billion for problems caused by the diabetes drug Avandia. Patients claimed that the drug increased their risk of heart problems and stroke. Thousands sued, including the federal government and more than 45 states.

GSK settled for $3 billion with the federal government. It agreed in November 2012 to pay $90 million to North Carolina and 37 other states. It settled for $229 million with South Carolina and seven other states in July 2013. GSK also settled private lawsuits. Those terms are confidential.

GSK said it “settled these matters to avoid the expense and uncertainty of protracted litigation and trial. The company did not admit to any wrongdoing or liability of any kind under these state laws in this settlement.”

Tribble said he lived with diabetes for close to two decades. “You just live in constant fear of: Are you going to live today? Are you going to live tomorrow?” he said.

Then came Avandia. He said the drug worked wonders. But, then, he claimed, he started having heart problems. 

GSK put the settlement money in escrow. Since then, it’s been up to various resolution groups to distribute the pot accordingly. But Tribble said he hasn’t seen any of the money.

“They just keep putting it [off], putting it [off], putting it [off],” he said.

Action 9 contacted the Ohio-based resolution group handling Tribble’s claim. Because of privacy reasons, it won’t say if he’s entitled to part of the money. In fact, under the Avandia settlement, it couldn’t even say how many people are still waiting or when they can expect a payout.

Even though GSK has paid the money and is no longer part of the process, it did exchange a number of emails with Action 9. The company said:

“The principal reason funds may remain in escrow is that the courts have required that a portion of the funds be paid to certain health insurers who provided coverage to settling claimants. GSK must rely on the claimants and their attorneys, who often engage lien resolution administrators, to identify and inform the appropriate health insurers of the existence of the settlements and to negotiate an agreement concerning the precise portion of each claimant’s settlement that will be received by the claimant’s insurer.  The process of resolving the insurers’ claims can be time consuming, although note that GSK is not a part of this process. GSK’s interest is only that settlement proceeds get distributed accurately.”

Avandia remains on the market.

More GSK Skullduggery… The 2013 GSK/FDA Avandia Whitewash…


Pharma & Healthcare
|
http://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/
5/23/2013 @ 7:30AM |3,227 views

Steven Nissen:

The Hidden Agenda Behind The FDA’s New

Avandia Hearings

Steven E. Nissen

This post was written by Steven E. Nissen MD, the Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. This commentary expresses his personal opinions and not necessarily the views of the Cleveland Clinic.

On June 5 and 6, the FDA will convene an advisory committee meeting on the diabetes drug Avandia, which was removed from the market in 2010 in most countries and placed under severe restrictions in the United States. Currently, only 3000 patients take what was once the best-selling oral diabetes treatment in the world. Its maker, GlaxoSmithkline (GSK), did not seek this public meeting and has publicly stated that it did not request modification to the drug’s extremely restrictive label. In 2012, GSK pled guilty to criminal misconduct related in part to concealing the hazards of Avandia and paid a $3 billion fine, one of the largest in U.S. history. In this context, why is the FDA seeking a new review of Avandia?

The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER), is seeking to avoid accountability for its role in the Avandia tragedy. In 2005 and 2006, GSK secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%. This observation had grave implications: two thirds of diabetics, the intended recipients of the drug, eventually die of cardiovascular complications. Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings. FDA statisticians confirmed the risks, but, incredibly, CDER and GSK agreed privately to conceal this hazard from patients and practitioners.

In May 2007, my colleague Kathy Wolski and I published an independent analysis of Avandia in the New England Journal of Medicine (NEJM), showing a statistically significant 43% increase in heart attack. In Congressional testimony, CDER officials acknowledged that FDA statisticians had confirmed our findings, reporting a 40% increase in the risk of heart attack. The leadership of CDER was intensely embarrassed by these revelations and furious with us for publicly challenging the safety of Avandia (and indirectly the competence and integrity of CDER). The FDA appeared incredibly insensitive to the welfare of patients. GSK knew, FDA knew, but patients and physician were not warned.

Since 2006, CDER has expended considerable taxpayer dollars trying to absolve itself of responsibility for this inexplicable error in judgment that cost many lives. In 2010, CDER and GSK saw an opportunity clear Avandia of any cardiovascular hazard and scheduled an FDA Advisory Committee meeting to exonerate the drug. CDER had received the study report for a clinical trial known as RECORD, conducted by GSK in Europe to examine the long-term safety of Avandia. Because RECORD did not confirm a cardiovascular hazard, key senior CDER leaders saw this as an ideal opportunity to absolve themselves of culpability in the Avandia scandal. However, the CDER plan backfired during the public hearings for four reasons:

  1. Independent FDA statisticians confirmed the hazards of Avandia, this time reporting an 80% increase in the risk of heart attack.
  2. FDA Deputy Commissioner Joshua Sharfstein took a personal interest in the issue and insisted that the Advisory Committee include independent scientists who would fairly judge the evidence.
  3. Dr. Sharfstein supported me in my request to present my independent analysis of the Avandia safety data to the committee.
  4. The RECORD trial was analyzed by legendary FDA reviewer, Dr. Tom Marciniak, a physician of the highest integrity and independence, and his review was devastating.

Marciniak’s 2010 review of RECORD showed extraordinary bias in the conduct of the trial. For example, the trial was unblinded; meaning that physicians and patients were aware which drug each patient was taking. Even GSK was unblinded. Incredibly, whenever a study site reported a clinical event, GSK and its contract research organization (CRO), knew immediately which drug the patient was receiving. Marciniak’s review showed that events occurring in Avandia patients were changed or deleted, sometimes months after they should have been reported and counted. These and many other flaws make the RECORD trial totally unreliable.

With a balanced committee membership and a fair hearing for both sides, the advisory committee voted overwhelming in favor of either removing Avandia from the market or severely restricting its usage (of 33 members, 12 voted for withdrawal and 10 for severe restrictions). European regulators banned Avandia entirely and US regulators relegated the drug to usage only in patients who had failed all other diabetes drugs.

However, the CDER leadership refused to accept the conclusion of regulators around the world and its own advisory committee that Avandia is hazardous. Instead, CDER arranged for the RECORD trial to be “re-adjudicated” (re-analyzed) by an outside group, the clinical trial center at Duke University. These Agency officials hope to show that the RECORD trial really did “prove” that Avandia is safe. If the RECORD trial was reliable, the logic goes, then the 2006 decision by CDER to conceal the risks of Avandia did not represent a dereliction of its public duty.

But GSK was allowed to prepare the materials for the Duke reanalysis, undermining the independence of the process. Beyond that, the entire idea of reanalyzing a trial that began in 2003 is simply ludicrous. Such a long interval seriously compromises the ability of adjudicators to retrieve original hospital records, laboratory findings, and other relevant patient data. Marciniak’s 2010 review revealed such extraordinary irregularities in the trial conduct that no subsequent effort could possibly correct the flaws.

The ostensible purpose of the June 5-6 Advisory Committee meeting is to consider the “re-adjudicated” RECORD trial. However, this time the meeting seems systematically designed to absolve the drug of harm and the CDER leadership of any responsibility for ignoring the public health hazard of Avandia. The current effort is intended to “whitewash” the Avandia scandal and re-write history. Certain respected and independent members of 2010 Advisory Committee have been recused from the 2013 meeting. I requested the opportunity to present an independent analysis to the Committee, but was denied and offered a 5-minute statement in the “open public hearing.”

Keen observers should compare the roster of this new committee to the 2010 hearings to determine which participants have been re-invited and which have not. Similarly, assess whether prominent drug safety experts within FDA, such as Dr. David Graham, are listed as speakers or excluded. Finally, will any GSK consultants address the panel?

Why are these hearings important? The FDA has been rocked by a series of scandals over the last decade. One FDA commissioner resigned under a cloud and later pled guilty to charges he had not reported owning stock in companies the agency regulated. Another commissioner resigned during the investigation of the use of political influence to gain approval of a medical device that was subsequently withdrawn. We have endured a series of drug and device safety disasters (Vioxx, Avandia, Ketek, defective defibrillator leads, and recently, compounding pharmacy oversight, and the list goes on) that have harmed many of our fellow citizens. In each case, the permanent FDA bureaucracy has sought to deny responsibility and often failed to learn the appropriate lessons necessary to prevent future catastrophes. In the middle of the sequester, CDER is willing to spend a large sum of taxpayer dollars to conduct a 2-day advisory meeting on a drug nobody uses, for the sole purpose of absolving its own bureaucracy of responsibility for a terrible drug safety tragedy. The current Director of CDER, Janet Woodcock, has directed this division for nearly 20 years, increasingly insulated from the Agency’s true constituency, the American public. If CDER is allowed to re-write the history of Avandia, this vital FDA Center will continue to function as an unsupervised, self-regulating bureaucracy, accountable to no one. That’s just unacceptable when the public health is at stake.

Dr. Nissen consults for many pharmaceutical companies, including companies making or developing diabetes drug. However, he requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.

Update: The FDA says that Nissen was invited to the previous meeting because his analysis was relevant, but that the topics he is covering would be covered by other speakers. “The FDA encourages participation from all public stakeholders in the open public hearing portions of advisory committee meetings,” the agency said. For the FDA’s full comment, click here.

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  • thefox2020 thefox2020 11 hours ago

    Would it be impolite to ask where Hon. Dan Levinson, HHS OIG, has been all these years, given the number of scandals that have rocked the FDA?

    • Called-out comment
  • Author
    Matthew Herper Matthew Herper, Forbes Staff 7 hours ago

    Maybe it’s impolite, but it’s certainly germane.

    • Called-out comment
  • Up until recently it was not prudent to say what he is saying.

    The least that you can do is support these things when they are finally said.

    • Called-out comment
  • rickwo rickwo 10 hours ago

    We can beat our chests all we want about this, but until sufficient thought and energy are directed toward eradicating (1) deregulatory fever and (2) the ubiquitous business-government-business “revolving door” career path, this will be the predictable outcome and our outrage is merely “a tale told by an idiot, full of sound and fury, signifying nothing”. This applies not only to drug safety, but also financial regulation, environmental hazards, climate change, education reform and on and on… Ironically, bringing more data to the table can backfire by reinforcing the opposition’s boilerplate position that this is all just too complex, as in “complex financial instruments, complex science, complex social issues” that are better entrusted to the invisible hand of the free market.

    • Called-out comment
  • It’s all about money. Governments & pharmaceuticals have been working hand in hand to get Americans to pay through the nose for any drug that they can for a long time now. Americans spend astronomical amounts of money both out of pocket & in taxpayer funds via medicare & medicaid for these things.

    There is zero oversight of governments in America today. & there has been zero oversight of governments in America for about one hundred & thirty years.

    Everything that governments in America are doing today is bad for the American People. This is not the exception, this kind of thing, is unfortunately the rule.

    The medias, political dementia, many things contribute to our nations problems. & no one today is contributing to the solutions. It’s like it has become somehow against us to do for ourselves. & we will let others do for us no matter how bad it gets. Unanimously. America today is united in utter failure.

    • Called-out comment

Remembering Steve Nissen: The Secret Glaxo Recorded Meeting About Avandia


GSK… Ethical? 

??????????????????????????????

http://www.cbsnews.com/8301-505123_162-42844274/secret-tapes-lay-bare-glaxos-scorched-earth-corporate-culture/

Secret Tapes Lay Bare Glaxo’s Scorched-Earth Corporate Culture

Just when you thought the news on Avandia — GlaxoSmithKline (GSK)’s troubled diabetes drug — couldn’t get any worse, it does. Steve Nissen, the Cleveland Clinic researcher who first went public with a study showing that Avandia increases heart-attack risk, secretly taped a meeting he had with GSK officials and caught them dissembling — to put it mildly.The event is yet one more example of GSK’s shoot-first, ask-questions-later approach to dealing with legal or PR challenges, one that’s now coming back to haunt the company.As Nissen discussed his concern that Avandia was needlessly killing people, GSK’s chief medical officer, Ronald L. Krall (pictured at right), stonewalled and obscured the fact that he had already improperly received a copy of Nissen’s impending Avandia study and that GSK was working on a rival study of its own. (Kudos to NYT reporter Gardiner Harris for breaking the story, by the way.)

In another black eye for the company, Pharmalot revealed today that Matthew Mintz, a doctor and pharma blogger for Forbes.com, failed to disclose that GSK paid him $11,050 in speaker and consulting fees, even though he has spent much of his time defending Avandia. (His item yesterday, for instance, is headlined “Another Unwarranted Avandia Scare.”)

And that news comes after it was revealed that GSK employed a fixer, Tachi Yamada, who spent part of his time making calls strong-arming the bosses of scientists working on research that highlighted Avandia’s risks.

If you need someone to blame, look to Sanofi-Aventis (SNY) CEO Chris Viehbacher. Why? Because Viehbacher was the head of GSK’s U.S. pharma unit during the decade in which this take-no-prisoners atmosphere was installed. These tactics weren’t only on display in the Avandia case — there are plenty of other examples of GSK’s studs-up aggression. Here’s a few:

To give you an example of GSK’s overreaching defense of itself, look at its press release from Feb. 20. On the subject of Avandia and heart attacks it says:

… the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events.

Now look at GSK’s own RECORD study of Avandia, published in The Lancet. That study had about 320 patients in two arms, one treated with Avandia (here referred to as rosiglitazone) and one with competing drugs. It concluded:

Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group

Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women.

GSK, of course, has every right to defend itself and its products. And the company deserves praise for its more recent moves toward transparency under CEO Andrew Witty. But it may be time for GSK to ask itself whether its policy of no-holds-barred fighting is setting it up for more losses than wins.

Related:

Families face battle with GSK over dangerous diabetes drug


GSK..
Helping people to do more, feel better and live longer!!!... 
YEAH RIGHT!..

http://www.guardian.co.uk/business/2013/jan/29/glaxosmithkline-legal-fight-uk-diabetes

Families face battle with GSK over dangerous diabetes drug

Exclusive: Pharmaceutical giant resists claims despite settlement with victims in US

Avandia pill bottle
GlaxoSmithKline has agreed to payouts in US lawsuits alleging Avandia pills could cause heart attacks. Photograph: Bloomberg/Getty Images

Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug’s harmful effects. But, despite this, GSK is not prepared to settle claims in the UK without a court fight.

The history of drug litigation in the UK suggests that families might not easily get  compensation.

Daniel Slade, with the Express company of solicitors in Manchester, has 19 cases on his books and has begun proceedings against GSK in four of them.

The pharmaceutical firm has told the solicitors that it will contest the cases. In just one of the cases it has indicated a willingness to spend £600,000 on its defence, which, the solicitor says, would be a fraction of what the claim is worth.

“It is very disappointing,” said Slade. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evidence. They are tasked with having to produce that evidence, including medical expert opinion. It is a burden one would have thought they might not have to go through.”

He expected that, if GSK fought in the courts rather than settled outside, as it had done in the US, it would take years for bereaved relatives, or those who have been harmed, to get any sort of payment.

A spokesman for GSK said: “We have every sympathy for people with complications associated with diabetes and those who care for them, but unfortunately we are unable to comment on individual legal cases. We continue to believe that the company acted appropriately and responsibly in its management of Avandia.”

Liz Thomas, policy manager at the patient safety charity Action against Medical Accidents, said it had “become increasingly difficult in the UK to challenge large corporations such as pharmaceutical companies, an incredibly expensive form of litigation”.

Corporations have a vast amount of money at their disposal to contest legal cases, but legal aid is about to cease for medical negligence cases.

The Avandia cases in Manchester will be fought on a “no win, no fee” basis by Express solicitors.

The cases in the US were settled by GSK extremely quickly, said Thomas. “I would hope they would not take advantage [in Britain] of the inequality of arms.”

Avandia was first introduced in the NHS in July 2000. It was given to people with type 2 diabetes whose glucose levels were no longer being properly controlled by the standard drugs – metformin and a sulphonylurea drug. Avandia could be prescribed with those drugs or on its own.

The drug, which generically is known as rosiglitazone, was designed to lessen the body’s resistance to insulin. It was available as a standalone drug – Avandia – or in a combination with metformin, and known as Avandamet.

When both drugs were withdrawn by the European Medicines Agency, there were about 90,000 people taking them in the UK.

The first warnings of trouble with Avandia came in 2007, when a prominent US scientist, Steve Nissen, published data from a review of 42 clinical trials which had been carried out on the drug. The trials involved 28,000 patients, and showed that Avandia could cause heart attacks. Further trials, the results of which were published in 2010, found people on Avandia were 27% more likely to have a stroke, 25% more likely to have heart failure, and 14% more likely to die, than patients on an alternative diabetes drug.

Potentially yet more damaging for GSK was its guilty plea to federal charges of concealing data about the drug’s side effects. Most of the data on the drug comes from GSK’s own trials. In November 2011 GSK agreed to pay $3bn to the US government over the Avandia issue and to end investigations into its marketing of the antidepressants Paxil (Seroxat in the UK) and Wellbutrin.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said at the time.

GSK is also still defending cases in the UK from people who claim to have been badly affected by Seroxat. A group action, involving people who say they suffered severe withdrawal problems when they tried to stop the drug, has been going on for years though many claims have been settled in the US.

The same is true of Vioxx, made by Merck, the painkiller that was withdrawn after it emerged eight years ago that it doubled the risk of a heart attack.

http://spirithappydiet.blogspot.ie/2013/01/diabetes-drug-causes-death-and-now-they.html

Diabetes drug causes death and now they want another pill approved

Spirit Happy has reported on the shady practices of Glaxo Smith Kline for many years. As far back as 2008 we reported that their drug Avandia would cause heart attacks and that is exactly what the drug did. Unfortunately this has not stopped them from seeking another Billion dollar profit drug for diabetes. They refuse to stop making diabetic drugs because it profits them over 4 Billion dollars a year.
Here is their History in Diabetes drugs
  1. Glaxo was ordered to pay 90 million dollars in the Unites States for the heart attacks and deaths related to their drug Avandia. We warned the public but few listened back in 2009, we told the public that very few people need a drug Type 2 diabetes, it can be reversed naturally. We informed the public that Avandia, Actos, and other high blood sugar medications were all dangerous drugs that destroyed the heart valve. The drug maker simply lie and they do it because the billions are too great a temptation for them. They simply want the money at any cost, even death to the person taking the drugs.
    1. 90 million is a low settlement seeing as the drug profited over 5 Billion dollars each year for 5 years. Each family victimized is reported to receive 53 thousand dollars. In addition the drug maker makes much more money on stocks once the drugs receive approval. When a diabetic drug is approved the company’s stocks fly up because it means millions in straight profit. This is the billion dollar big money game in pharmaceutical drugs.
    2. The story about Glaxo gets sicker as they were also found guilty of fraud, a 9 year investigation showed that the company lied to the public and hide information that the diabetes drug and other drugs they made were dangerous. They bribed doctors to promote their drugs. Did you know doctors get cash and vacations for prescribing a certain number of drugs? Glaxo sales reps lied and told doctors that the drug Avandia would even help the heart( while the drug really causes heart attacks) Drug companies have sales people who push the drugs on the doctors( Legal street drugs are not the only dirty drug game, prescription drugs may be more dirty)
    3. Glaxo salesmen get commissions( $) based on how many doctors they can get to prescribe the drug
    4. Glaxo was found guilty of hiding the heart attack risks from the FDA.
    5. Glaxo moved the dirty operation and had the drugss made in  factories in Puerto Rico to save tax dollars. What a shame.
These are the things they were found guilty of, this is not just an opinion, they admitted lying and hiding the truth and they pleaded guilty to all the charges above.
In total Glaxo has paid back the largest suit in US drug history 5 billion dollars, yet Glaxo profited over 20 billion dollars in 5 years from the diabetes drug
The drug business is a dirty business operated for huge profits.
In an amazing development Glaxo filed to the FDA to have a new diabetes drug approved and they have been approved last week!
The USA reported the story
GSK Diabetes Drug Receives FDA Approval As Initial Therapy
and here is the statement for Glaxo’s spokesperson
“GlaxoSmithKline is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world,” said Anne Phillips, vice president of Clinical for North America Cardiovascular-Metabolic at GSK,
What hypocrisy, they have admitted lying and defrauding the diabetic yet they say they are committed to helping the diabetic. . They caused deaths which no settlement could ever make up for. Glaxo stocks went up 1.6 % after the settlement and the stockholders were said to be “happy”  that they did not lose their investments in the company.
Diabetes for them is a stock market game with billions dollar of dollars at stake. Their executives make more money than the average person will ever see. Ask your doctor if type 2 diabetes can be reversed without drugs and he will inform you that it can. The drugs are part of a billion dollar con game.
We reported on Glaxo in 2009 and here in 2011 see here  Dangerous diabetes drugs

GSK lashes back at British newspaper in Avandia debate


http://wraltechwire.com/gsk-lashes-back-at-british-newspaper-in-avandia-debate/12061525/

Kinda reminds me of the same bullshit they came out with when the BBC exposed the hideous dangers of Seroxat 10 years ago. 

Different company? New Era? New Ethics?

The same bullshit, the same company and the same bullying behavior.

Leopards can’t change their spots.

_____________________________________________________________________________________________

GSK lashes back at British newspaper in Avandia debate

It’s a rarity when major multinational giants taken on – publicly, anyway –  news organizations over how stories are reported.

But GlaxoSmithKline (NYSE: GSK) has taken the proverbial gloves off in a duel with The Guardian newspaper in the U.K.

GSK Playing Hardball With UK Families Over Avandia Litigation,” the newspaper’s report said.

Given GSK’s decision on how to handle Avandia in the U.S. (it’s settling suits), the stance in the U.K. is interesting, to say the least.

The Defense

In a blog post at its website, GSK defended itself and the handling of Avandia cases after The Guardian reported the company will not concede defeat in lawsuits over the controversial diabetes drug.

“GSK response to news article in The Guardian on UK legal proceedings related to Avandia (rosiglitazone),” the blog post headline reads.

“Responding to a news article in The Guardian this morning (Jan. 30) on UK legal proceedings related to our type 2 diabetes medicine Avandia (rosiglitazone), we would like to make the following points:

“We have every sympathy for people with health complications associated with diabetes and those who care for them. However, respecting the UK court process, we are unable to comment on ongoing legal cases

“.We continue to believe that the company acted appropriately and responsibly in its management of Avandia.

“Specifically, it is wrong to suggest that we hid or concealed safety data relating to Avandia.

“We made Avandia clinical trial results available on our website and shared these with regulators.

“With respect to Avandia, the settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain Food and Drug Administration (FDA) regulatory reports of information regarding the initiation and status of certain studies.

“The Department of Justice has expressly acknowledged that the information had been provided by GSK to the FDA in other forms. The FDA has also stated that the omissions did not impact the agency’s evaluation of the safety data related to Avandia.

“We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type 2 diabetes when used appropriately.

“Nevertheless, we fully accept regulators’ decisions to restrict its use and have worked to make sure health professionals and patients understand this latest advice and guidance.”

The Offense

GSK’s response came after The Guardian reported that the company faces a number of lawsuits in the U.K. over Avandia.

“We expect the number of claims to increase as there are potentially thousands of people out there who took Avandia in the U.K.,” a lawyer told the newspaer. “Hopefully these claims will lead to more careful studies and checks on drugs that are widely marketed.”

GSK has said it paid more than $3 billion to settle U.S. federal and state government claims that it illegally marketed Avandia, once the world’s best-selling diabetes pill, and other medications. According to estimates by Bloomberg news service, individual Avandia settlements in the U.S. will be around $57,000.

“It is very disappointing,” the attorney said of GSK’s decision to fight. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evidence. They are tasked with having to produce that evidence, including medical expert opinion. It is a burden one would have thought they might not have to go through.”

If GSK leaders believed the Avandia settlements in the U.S. would make the nightmare go away, they obviously were mistaken.

GSK going public with a response to The Guardian shows the firm remains very sensitive to criticism about the drug and its handling. If court fights begin in public across the U.K., watch out …

[GSK ARCHIVE: Check out a decade of GSK stories as reported in WRAL Tech Wire.]

http://wraltechwire.com/gsk-lashes-back-at-british-newspaper-in-avandia-debate/12061525/

GSK: “We understand this is about our licence to operate.”


“We understand this is about our licence to operate.” 

GSK CEO – Andrew Witty’s comment about GSK’s 3 Billion fine for Fraud in 2012

http://www.guardian.co.uk/business/2012/jul/25/glaxosmithkline-chief-apologises-mis-selling

As 2012 comes to a close, I thought it might be interesting to demonstrate to my readers the scale of the damage done by just one GSK drug in the past decade. That drug is Avandia- now severely restricted in the US- and more or less banned in Europe- because of it’s propensity to kill.

It has been estimated that  GSK’s Avandia drug has caused up to 100,000 heart attacks in people across the world.

Just to give a visual image of the scale of damage from this one GSK drug alone- the following is a picture of 100,000 people at an Obama rally in Washington.

If we imagine that those 100,000 people have families and friends who are also affected because of the suffering of their friend or family member from an Avandia induced heart attack – then we can easily bring that number of people negatively or adversely affected by Avandia up to 500,000.

If we combine that figure with all the people who have been damaged by GSK’s other drugs- like Seroxat (Paxil)- which causes suicide, homicide and birth defects- then we could easily estimate that GSK’s drugs and products have caused in excess of over 1 million people adversely affected, damaged, or killed because of defective GSK drugs over the past decade.

Bear in mind- this further estimate takes into account just two GSK drugs (Avandia and Seroxat)- drugs that we know have caused widespread devastation for consumers. If we are to add the damage from their vaccines, and off label prescribed drugs– not to mention the cases of drugs which were contaminated (or in the wrong bottles)- from GSK’s Cidra factory– then we could easily bring that estimate of damage into the multiples of millions of people- either directly or indirectly damaged from GSK products over the past decade alone.

Happy New Year Folks…

barack-speaks-to-100000

GlaxoSmithKline fraud case: Does crime pay?


FOR FULL VIDEO AND DISCUSSION OF GSK FINE FOR FRAUD SEE LINK BELOW:

http://www.aljazeera.com/programmes/insidestoryamericas/2012/07/201271084038662313.html

In the biggest health care fraud settlement in US history, a federal judge approved a fine totalling $3bn for criminal and civil violations by the British pharmaceutical giant, GlaxoSmithKline, last week.

“Most of the examples … are of a drug that is approved for disease A and it is thought to be safe and effective for disease A but they’re not selling enough. It’s still on patent … as long as it’s on patent, as long as they can charge more, they will start pushing it for disease B and C and D for which there is no evidence that the benefits outweigh the risks so this is a strategy widely used by companies to increase their sales.– Dr Sidney Wolfe, co-founder and director of the Health Research Group

The company admitted illegally marketing the popular antidepressants Paxil and Wellbutrin and also withholding the data on the health risks of its best-selling diabetes drug, Avandia.

For seven years Glaxo failed to report data showing drug Avandia increased the risk of heart attack by as much as 40 per cent.

And the company claimed Wellbutrin was beneficial for weightloss and treating sexual dysfunction.

In the case of Paxil, GlaxoSmithKline promoted the drug for use by children and teenagers, despite the US Food and Drug Administration not approving it for patients under 18.

In fact, a clinical trial had found that the drug made adolecents more likely to attempt suicide.

Whistleblowers said that the company gave doctors lavish trips and spa treatments in order to pursuade them to prescribe the drug for uses not approved of through testing – what are known as off-label prescriptions.

Glaxo also hired a company to write a medical journal article downplaying the risks.

The US deputy attorney general called the settlement historic, saying it sent a clear warning to any company that chooses to break the law.

“They are doing the calculation … and it comes out in their favour that you might as well take the risk here. The basic economics are fairly straight forward, we know that these drugs could be produced, with few exceptions, very cheaply …. There is an enormous incentive for them to lie, cheat, steal, whatever, try and push these drugs.– Dean Baker, co-director of the Center for Economic and Policy Research

But there have been some other big drug companies that have been caught acting illegally.

In January 2009, the American pharmaceutical giant Eli Lilly agreed to pay more than $1.4bn for illegally promoting the drug Zyprexa.

Prior to Glaxo, the previous record-setting case involved Pfizer Inc., which in September 2009 paid $2.3bn for improperly marketing 13 different drugs, including Viagra.

In April 2012, Johnson & Johnson and a subsidiary were ordered to pay more than $1.2bn for minimising or concealing dangers associated with the antipsychotic drug Risperdal.

And in May, Abbott Laboratories settled for $1.6bn in regard to false marketing of the antiepileptic and mood-stabilising drug Depakote.

So, with the profits over more than a decade of illegal selling far larger than the amount Glaxo agreed to pay, will pharmaceutical companies really be put off? And do drug companies put profits before patients in the US?

Inside Story Americas, with presenter Shihab Rattansi, discusses with guests: Dr Sidney Wolfe, the co-founder and director of the Health Research Group; Dean Baker, the co-director of the Center for Economic and Policy Research; and Wendell Potter, an author and corporate health analyst.

Inside Story Americas also invited GlaxoSmithKline to take part in this discussion, but the company declined.

“Many observers, including myself believe that as long as it is just money that’s involved, it’s not a sufficient deterrent. The drugs that were involved in this settlement earned tens of billions of dollars over a long period of time. So the settlement was less than a single year’s sales of just one of those drugs, Avandia, the drug that I was involved in exposing the risks of. And so it’s just money, and it’s just part of doing business. Many people, particularly on Capitol Hill, believe that it’s time to begin holding these executives accountable for actual jail time when they commit this kind of criminal fraud.”Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2007 published findings that showed the health risks of the drug Avandia

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THE GLAXOSMITHKLINE FRAUD CASE:

  • GlaxoSmithKline promoted antidepressants for unapproved uses
  • Glaxo failed to disclose diabetes drug increased heart attack risk
  • The company pleaded guilty and agreed to pay $3bn fines – the largest settlement ever by a drug company
  • The fine includes $1bn criminal fine and $2bn for the civil settlement
  • The $2bn civil settlement involved asthma drug Advair and claims that Glaxo overcharged the US government
  • The criminal charges involved Paxil Wellbutrin and Avandia
  • The antidepressant, Paxil, brought in $11.6bn in sales for Glaxo
  • Sales of the diabetes drug, Avandia, brought in $10.4bn
  • Sales of Wellbutrin, another antidepressant, brought in $5.9bn for Glaxohttp://aje.me/Mi1MVF

News of GSK’s 3 Billion US Fine for Fraud and Corruption Explodes in the Media


I had intended to take a break from blogging over the Summer, but due to some explosive news about GSK making the rounds on all media outlets, I’ve decided to come back for a little while. My blog has had almost 400 hits already today, and twitter, the mainstream media and blogs have been abuzz with the news of GSK’s fine of 3 Billion for fraudulent marketing practices in the US (amongst other things). I have been blogging about GSK’s corporate crimes for 6 years. I am happy to see that finally the world can see just what a despicable corporation GSK is.

Here are but some of the links to some of the many articles doing the rounds on the internet about this:

http://www.guardian.co.uk/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals?newsfeed=true

http://abcnews.go.com/Blotter/pharma-giant-gsk-pay-3b-illegally-marketing-drugs/story?id=16695205

http://online.wsj.com/article/SB10001424052702303933404577505032006855076.html

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As this blog is primarily about GSK’s defective and dangerous Seroxat drug, some other news which I must post includes a story from Ireland’s major broadsheet, where a judge ruled that Seroxat was a major factor in a violent episode which turned a normal guy into a sword wielding maniac.

Check it out:

http://www.independent.ie/national-news/courts/man-attacked-terrified-party-guest-with-sword-after-mixing-alcohol-and-medication-3155427.html

A PATRY host who terrified his guests by waving a sword around and pushing a woman through a glass door has been given a suspended sentence.

A Party host who terrified his guests by waving a sword around and pushing a woman through a glass door has been given a suspended sentence.

The woman has since forgiven Rankin and was in court to support him. Rankin’s defence counsel said his behaviour was a result of mixing the alcohol and the anti-depressant medication, Seroxat.

http://youtu.be/t4q6EwbBv3I