Posts Tagged ‘ Avandia ’

Whistle while you Work? Sad Reality in American Business

November 2nd, 2010. By Hunter West

Anyone who is aghast at the recent $750 million GlaxoSmithKline (Glaxo) whistleblower judgment to settle manufacturing deficiencies at a former plant in Puerto Rico shouldn’t be surprised that such things are going on. Happens all the time, it seems. And not just to Glaxo, either.

In actual fact, that $750 million—of which the whistleblower earns a share of the penalty totaling a whopping $96 million—pales in comparison to the $3.1 billion that the US Department of Justice has recovered under the federal False Claims Act so far in just this fiscal year alone.

Last year the haul was almost twice that—$5.6 billion.

Some will say that the whistleblower is an opportunist hoping for a big payday in the end, and will take any amount of criticism and crap en route to the pot at the end of the rainbow. Hell, I’d put up with a lot of grief to collect $96 million.

I would even eat liver.

But to those who view whistleblowers as ambulance chasers, consider the amount of fraud and wrongdoing that serves as a persistent blight on the business landscape. Somebody has to expose such misdeeds—and if the government can’t route out the evil-doers (sorry ‘W’…) on their own, then they have to provide incentive for those who can.

We would all wish that whistleblowers were not necessary. In a perfect world every business and corporate entity would operate with integrity and play by the rules.

Sadly, that’s not the case.

According to Taxpayers Against Fraud, a not-for-profit that supports whistleblower lawsuits, Read the rest of this entry »

Tags: Avandia, Eckard, GlaxoSmithKline, GSK, paxil, Qui Tam, Whistleblower
Posted in Whistleblower | 5518No Comments »2010-11-02+13%3A39%3A50Hunter+West

Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure…

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events.

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product.

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI
Posted in DePuy ASR Hip Recall, Drugs/Medical | 5153No Comments »2010-10-06+14%3A37%3A25LucyC

FDA vs Attorneys: Who Really Protects Us?

September 27th, 2010. By janem

There’s always some whining going on about how much money lawyers make from pharmaceutical class actions. But do those whiners ever think about how safe we would be were it not for the lawyers, lawsuits and the courts? Let’s add advocacy and consumer groups too—their actions have also kept us safe from dangerous drugs and their side effects.

Relying on the FDA for post-market surveillance once it has approved a drug reminds me of this old adage: Close the stable door after the horse has bolted. All too often it takes consumers and their attorneys—like a band of Davids against the Goliath drug company—to resolve adverse drug events that occur by underhanded tactics such as off-label promotion and false advertising. Case in point: the diabetes drug Byetta.

The FDA received reports of adverse health events (kidney problems and pancreatitis) from Byetta users since the beginning of 2005 but they did diddly squat until last November, when in their infinite wisdom, finally said, “Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.” But not before attorneys were filing class action lawsuits against the manufacturer.

And what about Avandia? In 2007, a report in the New England Journal of Medicine, linked Avandia to a 43 percent increased risk of heart attack, and more than 700 lawsuits—with GlaxoSmithKline agreeing to a $60 million settlement. Yet it took the FDA until September 2010 to severely restrict sales of the drug (sales have been completely suspended in Europe).

And let’s consider Zyprexa. Class action lawsuits alleged that the manufacturer, Eli Lilly and Co., negligently made, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007. Eli Lilly paid out approximately $1.5 billion to settle civil and criminal claims alleging illegal marketing—promoting the drug for use in seniors with dementia when it is not approved for that use.

As well, Eli Lilly paid millions of dollars to settle claims alleging the increased risk of diabetes and related health problems, but the settlement does not imply liability or wrongdoing, so are we safer as a result? The drug is still sold, but with the labeling clearly showing diabetes-related side effects. But Zyprexa treats psychosis—how many people with schizophrenia or bi-polar disorder are going to read the label? Attorneys have taken the drug company to court; now isn’t it up to the FDA to take the drug off the market? Or at the very least, the agency should be more diligent with post market surveillance.

Tags: Avandia, Byetta, Zyprexa
Posted in Drugs/Medical | 5070No Comments »2010-09-27+16%3A16%3A43janem

Kevin Bacon Game helps Decipher Diabetes-related Drug Lawsuits

September 2nd, 2010. By AbiK

If you’ve ever wondered why certain drugs (Zyprexa, Avandia, Seroquel, Cymbalta…to name a few) seem to have something in common, but you just can never really put your finger on it, well, it’s time to look to the Kevin Bacon Game (aka, Six Degrees of Separation, with some liberties taken) to find out what those connections are…so here goes…

Tags: Avandia, Cymbalta, Diabetes, Janumet, Januvia, Kevin Bacon, Risperdal, Seroquel, Symbyax, Zyprexa
Posted in Drugs/Medical, Emerging Issues | 48541 Comment »2010-09-02+17%3A15%3A11AbiK

How the FDA Advisory Panel Vote Affects Avandia Patients

July 15th, 2010. By Kristine B

If you’re like other Avandia patients out there, you probably waited for the FDA advisory panel’s vote yesterday with some concern (or maybe you didn’t). Yesterday was the day the FDA advisory panel voted on whether or not to remove Avandia from the market. So, today we examine how the panel voted and what that means for you.

First, what you need to know about the panel. The panel is only advisory. This means that the FDA doesn’t have to follow the panel’s recommendations. Sure, it usually does, but that doesn’t mean it always will. So, all the panel can do is make recommendations. Whether those recommendations will be followed is up to the FDA.

So, what did the panel recommend? Well, depending on how you view it (and whose articles you read) Avandia was either dealt a severe blow by the FDA or won a major victory. Hunter’s Avandia post today calls it a “muted win” for GSK, which probably sums it up best.

On the question of what to do with Avandia, panel members voted as follows:

12 voted to withdraw the drug entirely

10 voted to allow it to remain on the market with strong label revisions and possible sales restrictions

7 voted to add further warnings to Avandia’s label

3 voted to allow continued sale of Avandia with no changes

1 abstained

So, there are two ways of looking at this: Either the majority of panelists (22) voted to either withdraw Avandia from the market entirely or only allow it under stronger warnings and sales restrictions, or the majority of panelists (20) voted to keep Avandia on the market rather than withdrawing it. Nothing is ever simple when it comes to pharmaceutical decisions.

What does that mean for patients taking Avandia? Right now, it doesn’t mean anything. You haven’t been told to stop taking the drug, although 18 panel members voted that they are concerned Avandia causes heart attacks (nine said they weren’t sure about the risk of heart attacks and six said they weren’t concerned about the risk of heart attacks).

So, if you’re concerned about taking Avandia, you should speak with your doctor about the risks. But don’t stop taking it without first speaking to your doctor about your concerns.

The FDA will make a decision later about whether or not to continue to allow Avandia on the market.

Meanwhile, GlaxoSmithKline has reportedly settled 10,000 Avandia lawsuits for approximately $460 million. If you think you may have an Avandia claim, your best bet is to file your claim with a lawyer who is specializing in Avandia claims.

Tags: Avandia, Avandia Lawsuit, FDA, GSK, Pleading Ignorance
Posted in Drugs/Medical, Emerging Issues | 4396No Comments »2010-07-15+16%3A06%3A56Kristine+B