Posts Tagged ‘ Glaxo ’
Avandia and Alzheimer’s…What If?
September 24th, 2009. By LucyC
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.
Paxil Birth Defects Trial Underway in Nation’s Birthplace
September 14th, 2009. By AbiK
It’s somehow eerily fitting that the bellwhether trial case for GlaxoSmithKline’s (GSK) Paxil is taking place in Philadelphia—the nation’s birthplace. You can’t really think of such a trial going on in Philly without recalling a few excerpts from the Declaration of Independence—and not just the more famous lines about unalienable rights but also some lesser quoted phrases like ”Such has been the patient sufferance of these Colonies”; substitute the word “mothers” for “colonies” and you’ve just advanced 233 years to be talking about Paxil.
At the heart of the trial that’s now underway is GSK’s allegedly knowing—and failing to warn patients—that its anti-depressant drug, Paxil, could cause birth defects.
All eyes are on this first case which centers on Lyam Kilker, now 3, who has suffered life-threatening heart defects since birth. According to bloomberg.com (9/11/09), Michelle David, Lyam’s mother, was quoted as saying that:
…she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.
She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.
“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.
Needless to say, GSK’s position is that there’s no mea culpa; however, reports estimate at least 600 additional cases waiting in the pipeline for the outcome of this trial to say just whose culpa it is. For the sake of legacy of our forefathers, let’s hope prudence prevails.
Appetizing Alli: Gas, Oily Spotting and Possible Liver Damage?
August 25th, 2009. By AbiK
Whoo-boy!
There’s a successful date night waiting to happen. Slim down with Alli, fit into that outfit and oh, by the way, can we stop at Rite Aid for some Gas-X?
Back in 2007 when Alli was approved for OTC use for weight loss, anyone and everyone who was looking to lose a few pounds was all over it. What wasn’t to latch onto and love? Pop a pill, and let the pill block about 25% of the fat your body would absorb during a given meal.
Ah, but as with all weight loss plans, there were a few catches. Yes, exercise is advised. And yes, diet modification is not only advised, but necessary. See, that excess fat (the 25% mentioned above) that isn’t absorbed needs to go somewhere—somewhere out of your body. And that can mean gas, “oily spotting” (that’s how Glaxo’s site describes it), or loose or more frequent stools that may be hard to control.
I love this line from Glaxo—while truthful and transparent, which you have to give them credit for, I challenge anyone to read it and not go “ewww!“:
Lawsuits Needed Against Prescribing Quacks
April 24th, 2009. By Evelyn Pringle
On April 21, 2009, the Miami Herald reported that a 7-year-old boy in Florida, Gabriel Myers, had committed suicide by hanging himself with a detachable shower head in a bathroom of the foster care home he was placed in three weeks earlier.
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