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.
If you love a bit of irony, this one’s for you.
Betty Nestlehutt has found herself in the news spotlight lately. Betty’s a septagenarian out of Marietta, GA who underwent facelift surgery back in 2006—she’s a realtor and, according to reports, she had the facelift to be able to compete with younger real estate agents. The facelift didn’t go so well, and so sued for malpractice. But then a strange thing happened at court—she not only won, she won big: to the tune of over $1.2 million. Probably small solace for all she’d been through.
Regardless, she’s the center of attention again in 2009 because her case has become the center of a new case—the one in which her attorneys have asked the Georgia State Supreme Court to overturn a state law that caps damages in medical malpractice lawsuits at $350,000. (If you’re doing the math, yes, Betty’s settlement was greater than the $350k cap).
Now, here’s the irony. As any curious blogger would do, I went to check out Betty online. And I found her real estate site—she’s with Prudential. And as I’m scrolling…ta da!…there it is: a nice-sized display ad for SunTrust mortgages.
And I’m thinking of another set of septagenarians and beyond who allegedly found their SunTrust HELOC accounts frozen. And I’m wondering if Betty knew about that situation. And I’m just thinking of the irony…older real estate agent feels potential age discrimination in the marketplace, has botched facelift, sues, wins, displays advertising from company that allegedly, sorta kinda may have engaged in a bit of age discrimination…
God bless Betty and all she’s been through; and God help all those folks still waiting on answers from SunTrust…
If you’ve been following what’s hot in beauty, you’ve seen the ads for Allergan‘s (also maker of Botox) Latisse where Brooke Shields lends her face to promote the eyelash enhancer. And you’ve probably caught the onslaught of vibrating mascaras. Yes, all this to “play up” what amounts to 1/1,000,000,000,000,000th of the surface area on a woman’s body.
But those tiny lashes are big business. Allergan had estimated pre-launch of Latisse that the previously-only-known-as glaucoma treatment could rake in over $500 million a year. Who knows just how much a mascara wand that needs batteries could bring in. I admit to owning one, but I also admit it was a gift and after thoroughly cleaning it, it actually makes a handy gizmo for cleaning tile grout (beauty tip!).
The FDA, however, is not so wowed by all the hoopla surrounding Latisse. In fact, it appears the Read the rest of this entry »
What comes first: will Bayer issue a recall of Yasmin/Yaz or will the drug company simply stop making its wildly popular and extremely dangerous birth control pill? For Bayer, the decision likely boils down to cost: can more claims be settled by taking the drug off the market? Poor Bayer has plenty to worry about these days. Not only are Yasmin/Yaz lawsuits related to life-threatening side effects stacking up, it was also served a warning letter from the FDA regarding quality control problems.
If and when Yasmin is taken off the market it will surely affect Bayer’s bottom line: In 2008 Yaz brought in $616 million for the company and Yasmin sales brought in $382. And sales increased from the previous year, mainly due to aggressive marketing campaigns that have since been called “deceptive” and “misleading” by the FDA. Advertising is a powerful tool: according to numerous Yasmin users I have spoken with, they had no knowledge of these side effects nor did they hear of any warnings: after all, if you knew Yasmin was life-threatening, you certainly wouldn’t be taking it!
So what’s taking the FDA so long to issue a recall? The agency must act on the countless reports of thrombosis, heart attack and stroke and even gallbladder disease associated with Yasmin and Yaz.
It wasn’t long ago that several fatalities were directly linked to the Ortho Evra birth control patch and it never did get recalled, even though last May the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months. I wonder how many deaths it will take to remove Yasmin and Yaz from the market…
The Vancouver Island Health Authority (VIHA) has confirmed via Canwest News Service that it will cut MRI scans by 20%. That’s a staggering figure-think of it, one in five individuals who previously would have been sent for an MRI, won’t be. To anyone south of the Canadian border, it seems unconscionable. Of course, to anyone south of the border who has an HMO, well, they’re used to being told “no can do” or you need to pay through the roof-so not sure which scenario’s better.
But, regardless of any healthcare debates, you have to wonder whether the reduction in MRI scans will have any measurable impact on the amount of patients who innocently go for their MRI, only to be injected with a gadolinium contrast agent, only to learn later that they’ve got some serious kidney problems.
Gadolinium contrast has been linked to Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD)-MRI health risks that are real and very serious. Read the rest of this entry »