Posts Tagged ‘ Avandia ’

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 | 2 Comments »

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 | 2 Comments »

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 | No Comments »

A Muted Win For Avandia Manufacturer—But Stay Tuned…

July 15th, 2010. By Hunter West

So Avandia has been stayed from execution—for now—by virtue of a majority vote by an expert panel of experts brought together by the US Food and Drug Administration (FDA) that debated the drug’s safety and efficacy for two days this week. The Type 2 diabetes drug that has been under much fire for the past couple of years was further challenged by the long-awaited gathering which ended with a vote to leave Avandia, manufactured by GlaxoSmithKline (Glaxo), on the market for the time being.

But the victory for Glaxo is muted.

While the panel voted 20-12 to leave Avandia on the market, it will not likely be left alone. That’s because at least half of those voting ‘yay,’ according to the July 14^th edition of the Wall Street Journal (WSJ), tied their vote of support to increased restrictions on a drug that has already faced significant reduction of sales since 2007. Supporters of the drug who voted to keep Avandia on the market indicated after the vote that they only did so due to the lack, they said, of hard evidence with regard to potential harm.

They also said Avandia should be used only as a drug of last resort.

That’s good news for rival Actos, manufactured by Takeda Pharmaceuticals. Even though both Avandia and Actos carry black box warnings for fluid retention and the ensuing risk for heart failure, Avandia is thought to carry a greater risk for heart attack than its rival.

So much so, in fact, that the FDA directed the advisory panel to put that matter to a vote, pitting Read the rest of this entry »

Tags: Actos, Avandia, FDA, TIDE
Posted in Drugs/Medical, Emerging Issues | No Comments »

Avandia Study Conflicts – and Conflicts of Interest?

June 30th, 2010. By AbiK

So after the latest two Avandia studies came out earlier this week, we then see a third Avandia study—this one will also be debating fodder for the advisory panels at the FDA’s July meeting—the one that will determine Avandia‘s fate. The study was presented late Monday at the American Diabetes Association’s annual meeting by Dr. Richard Bach, associate professor of medicine at Washington University School of Medicine in St. Louis.

Here’s the thing though—the fist two studies basically added a few nails in Avandia’s ever-growing coffin. But this latest study to hit the airwaves actually digresses from the previous two in its findings—it states that there is no increased risk of heart attack, stroke or death associated with taking Avandia.

Hmm. Doesn’t that just make things a little…less definitive?

However, upon looking more deeply into this third study, some things about it just sort of pop out. For example, according to an article from healthfinder.gov, this third study if of a smaller sample size: 2,400 patients—compared to over 35,000 from the study done at the Cleveland Clinic.

There’s more..

• The third study was funded by the National Institutes of Health (NIH). Oh, and GlaxoSmithKline (GSK). Oh, and if you recall, GSK just happens to make Avandia. Conflict of interest? (just asking).
• While death, heart attack and stroke incidence rates were apparently 28 percent lower in the third study for those taking Avandia vs. those not taking a thiazolidinedione (TZD) medication, congestive heart failure was higher—just not at a rate “considered significant”. What was significant was a 45 percent increase in risk of fractures for those who took Avandia. (Ok—not heart-related, but 45 percent sounds more than significant to me).
• Apparently the ages of the participants in the third study were lower than that of the other studies. Translation: the other studies’ participants may have been more frail. Two things here: first, I don’t care what ages folks are who are affected by a drug–everyone’s well-being matters. So if an older population is more adversely affected, they’re still adversely affected. And second, so the tests are not comparing apples to apples–which should detract from the ability to make comparisons and draw conclusions.

Hard to say where the FDA advisory panel will net out in July. Will we still see Avandia on the market? Stay tuned.

Tags: Avandia, Glaxo, GlaxoSmithKline, GSK
Posted in Drugs/Medical | No Comments »