If you’ve read the news lately, you may have heard that GlaxoSmithKline agreed to settle approximately 700 Avandia lawsuits for a reported $60 million. You may also have heard the calls to end the Avandia safety trial known as the TIDE trial. This may have you concerned about how these developments affect you, and rightfully so.
This week, Pleading Ignorance takes a look at how the Avandia settlement and the controversy over the Avandia and Actos TIDE trial may affect you.
GlaxoSmithKline has reportedly agreed to settle 700 lawsuits for approximately $60 million. How this settlement affects you depends on where you are in the lawsuit process, if you are involved at all.
Obviously, if you’re one of the 700 lawsuits that have been settled, then your lawsuit is now done; you’ll receive your share of the settlement and no longer have to worry about the litigation.
If you are one of the remaining lawsuits (reported to number in the thousands), how this settlement affects you is less clear. Details about the settlement have been kept quiet. Based on how big businesses operate, my guess (this is just speculation here) is that GlaxoSmithKline has not admitted to any wrongdoing (something most businesses attach to their settlements). The settlement, however, shows that the drug maker is willing to sit down with plaintiff’s lawyers to negotiate, which could be a good thing for the remaining lawsuits.
That said, there is no guarantee that a settlement in those 700 initial lawsuits will translate into a settlement for the remaining lawsuits. It’s a good sign, but it’s no guarantee.
If you are considering contacting a lawyer but haven’t done so yet, the statute of limitations might be running out for you. One of the things that plays into how much time you have to file is whether or not your state follows a discovery rule. What’s that? Basically, it’s the point in time in which an individual would have likely been aware that a claim could be made against a defendant—or that a claim existed. In the case of Avandia, that would mean the point at which a person most likely knew they Read the rest of this entry »
So here’s an interesting twist. Avandia, also known as rosiglitazone, once GlaxoSmithKline’s (GSK) blockbuster diabetes drug that turned out to be not so good for you after all, has failed to prove benefit in clinical trials as a treatment for Alzheimer’s disease.
Why was GSK testing Avandia in Alzheimer’s, you ask? Well, sales of Avandia plummeted after the now infamous Nissen study was published in 2007 showing a link between the diabetes medication and heart attacks. In fact, one source puts 2008 sales down by 40 percent from 2007. So, GSK was looking for a new indication that would generate some cash—up to $300 million one estimate suggests.
So GSK must look for new ailments for Avandia. After all—product recycling applies to the pharmaceutical industry just as it does in other industries.
But what if Avandia had proven beneficial in treating Alzheimer’s—whatever ‘beneficial’ was defined as being? It is unlikely that the risk for heart attack would have disappeared or not been an issue in this population. So I find myself wondering about the ethics of testing a drug with an established link to potentially fatal adverse events, such as heart attack, in a population that may not be able to articulate their health problems. Not only that, had Avandia made the grade, would the FDA have approved the indication, despite the health risks?
Perhaps the most worrying element of all this is why Avandia is being tested at all for any additional indications, when there are very real concerns about it remaining on the market in the first place.
The Avandia/Actos battle has been making headlines since August 19 (BMJ.com) when a Canadian researcher suggested the oral diabetes treatment Actos is safer than Avandia. (Coincidentally, Takeda Canada announced a few days later that it reacquired the Canadian marketing rights for its Actos from Eli Lilly’s Canadian company. The drugmaker licensed the rights to Lilly under a worldwide agreement in 1999—financial arrangements were not disclosed.)
The similarities: Both Avandia and Actos belong to a class of drugs called thiazolidinediones, which are used widely to lower blood sugar in people with type 2 diabetes. In addition to an increased risk for heart failure, both drugs can also cause side effects that include weight gain and fluid retention. Both medications carry a U.S. Food and Drug Administration warning and both meds run the same risk of heart attack.
The discrepancies: Researchers found that patients taking Avandia were at greater risk of Read the rest of this entry »
Pleading Ignorance recently posted about what a “Statute of Limitations” means. And while each state has its own guidelines for when the amount of tme to file a lawsuit runs out, the bottom line is that, well no, you can’t just file whenever you feel like it.
So keep in mind, if you’ve been affected by adverse effects from either Heparin or Avandia, you can still file–but you need to be mindful of filing deadlines.
We recently posted a blog about filing for Heparin; and an article for filing for Avandia.
If you wish to consult with a lawyer on either case, click here for Heparin and click here for Avandia. It’s free. And remember, while deadlines are in place, a lawyer ideally needs about a month in advance of that deadline to ensure he has time to review your individual situation and to pull together any necessary paperwork. So the clock’s ticking…
Researchers working with Public Citizen must feel like they’re banging their heads against the FDA wall when it comes to Avandia and liver failure. Their recent study of adverse events (called “Case series of liver failure associated with rosiglitazone and pioglitazone” ) reported 11 deaths due to liver toxicity between 1997 and 2006 associated with the use of Avandia. Public Citizen has also been petitioning the FDA since October, 2008, to ban Avandia, saying the drug’s risks outweigh its benefits.
You’re probably thinking that 11 deaths are rather insignificant in the big picture: Public Citizen reported that in 2006, the number of prescriptions filled for the drug peaked at 13.2 million and dropped to 3.1 million in 2008, which means about 8,500 prescriptions a day are still being filled for Avandia.
But those same researchers have pointed out that reporting rates to the FDA are low; most patients who develop liver disease from Avandia likely never report it: They believe 1 in 44,000 patients who take Avandia are at risk for developing liver failure. And Dr. Sidney Wolfe, acting president of Public Citizen, director of Public Citizen’s Health Research Group and co-author of the report, said “The research [on Avandia and liver failure] is yet another indication that Avandia is too dangerous to remain on the market”.
Still, the FDA hasn’t taken this dangerous drug off the market, even though there are safer alternatives. Perhaps the agency is taking into account the manufacturer’s take on all this. According to latimesblogs.com (July 25, 2009), GlaxoSmithKline argues that no scientific study has linked the drug to liver toxicity. After all, 8500 prescriptions a day=cha ching…