We don’t joke about asbestos here at LawyersAndSettlements.com. Let me just put that out there to start. But, considering that Canada hasn’t banned asbestos mining yet, and that one of the towns in Canada where asbestos mining still goes on is called…drumroll please…Asbestos, well, sometimes a little humor goes a long way.
How?
Consider this. Suppose you live in Asbestos, Quebec. And suppose the name isn’t just some coincidence—yes, there’s a reason it’s called Asbestos and the reason is that there’s an asbestos mine there. WolframAlpha puts Asbestos’ population at 15,381 (personally, I’m surprised it’s that many); CBC.ca puts it at 7,000. Regardless, those 7,000-15,000 folks living there are sitting amidst an ongoing hotbed of asbestos-mining debate. Just recently, the town found itself in the middle of a conundrum—it had to make a choice: either support its local asbestos mining operations or support an anti-asbestos charity walk—the Canadian Cancer Society’s Relay for Life—that was set to walk right through their town. Well, money talks, so the walk was asked to take a hike.
So yes, you could say Asbestos, Quebec has a little image problem.
What to do? You want folks to visit, of course. But what will they think?—Visit a town that seemingly supports an industry that the majority of the world has already banned? Visit a town that has active asbestos mining going on and risk a vacation with microscopic asbestos fibers wafting through the air? True or not, this is what the average person—you, me—is thinking about the lovely hamlet of Asbestos.
Problem? Yes. Solution? Time for an ad agency. So Jane just sent me this video clip—and we had to share.
The video above takes a look at how one might create an ad to overcome such image challenges. And yes, humor is employed—but what other option is there? It’s a classic case of when things get so bad all you can do is laugh…
I’ve got a better solution: hey Canada, ban asbestos mining.
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.
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 14th 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 »
Despite a recent study that puts into question the link between Byetta and pancreatitis, I was looking back over Byetta’s history as it relates to FDA labelling. For some background, Byetta came on the market in 2005—to treat patients with type-2 diabetes—and some reports indicate that over 10 million Byetta prescriptions have been written since 2005.
But since 2005, there have been some other interesting (or should I say “disturbing”) developments with Byetta as well. According to the FDA, between April 28, 2005 and December 31, 2006, there were 30 domestic reports of acute pancreatitis in patients who were taking exenatide (the generic name for Byetta). Clearly feeling that thirty such cases within the span of just under two years was perhaps worth raising an eyebrow, the FDA responded with some additional Byetta warnings. Here’s what happened:
October, 2007: the FDA mandated that Amylin and Eli Lilly include stricter, more prominent warning labels about possible Byetta side effects on Byetta’s packaging; the new Byetta warnings included acute pancreatitis.
August, 2008: the FDA issued an alert to healthcare providers regarding six additional cases of necrotizing or hemorrhagic pancreatitis among Byetta patients. Two of those six cases resulted in death.
November, 2009: Between April, 2005 and October, 2008, the FDA had received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Based on this, the FDA issued new safety information on Byetta to include a warning of possible kidney function problems a a side effect.
Now, while I surely don’t believe the FDA is incapable of error or misjudgement (we only have to look to Avandia this week to question such), it does seem that when the number of reports Read the rest of this entry »
KFC and Yum! Brands Inc got hit with some bad news this week—a judge in Chicago has ruled that four lawsuits filed against them can proceed. What’s the beef? A bunch of crow. (Be warned, this could get worse…I’m on a roll).
In fact, it’s all about chicken—free chicken—KFC grilled chicken meals with two sides and a biscuit, in fact. Cast your mind back to May 2009, when Oprah Winfrey announced that KFC was making coupons available across the country for the free meal. Well, no surprise—KFC was inundated. I recall this making the national news—people lining up for their free meals—with coupons in hand—only to be provided with a ‘rain check’ coupon when they got the counter.
It should be noted that KFC printed more than 10 million coupons, according to a story in BusinessWeek. A spokeswoman for KFC is quoted in the BusinessWeek article, saying “Due to the overwhelming response, we distributed millions of rain check coupons for the holders of valid coupons who we were unable to serve during the offer period.”
The promotion was supposed to run for two weeks and instead got shut down after two days. Some 5.7 million people were allegedly denied their free meals, which apparently retail for $3.99.
So, a class action lawsuit has been filed. The judge in Chicago believes the allegations have grounds for common law fraud.
Well. I’m in two minds about this. First of all, it was a nice gesture of KFC to offer these Read the rest of this entry »