The vultures pounce
Investors can be deaf, dumb and blind when their portfolios increase in value but as soon as they lose some equity they need to reach out and affix blame. The plaintiff in the case is Leon D. Borochoff, represented by Kaplan Fox & Kilsheimer of New York. Frederic Fox, a lawyer with the firm, said Mr. Borochoff declined to comment. Declined to comment because he is probably already thinking about the new Lexus and summer house he is going to purchase when he settles with GSK. Make no mistake about it, if GSK did in fact manipulate or hide data to get FDA approval then by all means they should be subject to shareholder repercussions but how about waiting to see if there is in fact misreporting here rather than just assuming that GSK erred.
This is the
environment that we market in today. It's a
jungle with threats looming in every corner and
don't think that consumers are not taking notice.
On investor boards there is a lot of talk but
just take a look at the message board on
Healthboards.com and look at the postings about
Avandia.
Yikes! I just started taking this about a month ago. It takes 8 -12 weeks before the med actually starts to show any benefits and so far, it hasn't made any difference for me yet, but it has only been 5 weeks. I hope when I see my doctor in a few weeks he will advise me to stop taking it.
Then there is this post:
I was diagnosed in Dec with T2 diabetes and started Avandia and metformin immediately, plus a low carb diet and cinnamon and chromium. April 5 I had a heart attack-no warning. Saved only by the Grace of God and the fact that I live 4 blocks from the hospital. I have since been dealing with an allergic reaction to Plavix and the drug eluding stents they had to put in to clear my blocked RCA. I immediately broke out in a severe rash and now all my skin is peeling off.They had to put me on large doses of Prednisone which raised my blood sugars terribly, and gave me shingles.I now have to take a drug with a "black box" warning on it and get blood work every 2 weeks to prevent my stents from clotting off and killing me. The drug that I'm on, Ticlid, causes SEVERE blood disorders that may kill me.Oh, and I was just told I have phlebitis in my hand and arm where they put in my IV over 7 weeks ago!
I called my Dr today and he said DO NOT take Avandia anymore and am starting Januvia tomorrow. I got my post-M.I. echocardiogram today and the tech was alarmed to see fluid around the outside of my heart-(pericardium).
I know that Diabetes and heart attacks are life threatening problems, but I've about had it with "modern medicine" and their pills. Any encouragement out there? I am a first time poster-long time silent reader and am always buoyed by all your support of each other. So sorry about the long post but I am almost at wits end.
As you can plainly see consumers are talking to each other, sharing experiences and concerns. Yet pharma largely ignores them even when there is good information that they should be communicating in different forums. Web MD for example recently posed a BLOG by a RN who questions the recent findings on Avandia. Although GSK does have a relationship with Web MD in sponsorships the argument she makes is based on logic and data:
This week, in a widely publicized study, which is actually an analysis of a group of studies called a meta-analysis, it was concluded that use of the diabetes drug rosiglitazone (Avandia) causes a significant increase in the risk of having a heart attack. It also concludes that there is a greater risk of death from all cardiovascular diseases, which includes heart attack and stroke, while taking the drug. But is this true, or is it a trick of the statisticians? Let's look at a few of the details of this "study."
First, the author took a group of 42 studies that included the use of rosiglitazone. These studies were not specifically designed to look at heart disease risk, so this begs the question: if the studies didn't control for other causes of heart attack and stroke risk, how did the author of the meta-analysis determine that there were no other causes of these increased risks in the study?
For example, poorly controlled diabetes and elevated blood lipids both increase the risk for heart attack and stroke, so how did the author control for those factors if the original studies did not? Additionally many of these trials were small and short-term, with an inadequate number of participants and too little duration to really determine the long-term risk of developing cardiovascular disease (CVD).
Next, the author took the "publicly disclosed data summaries" from these 42 trials and used that information to draw his conclusions. This means that the author is drawing his numbers from the best "spin" on the original data, not the original study numbers themselves.
.Finally, there is the little problem of the statistician's spin on the data, which is reported from analysis of the "odds ratio" rather than the "relative risk" of a particular event happening. Statistical analysis makes my eyes glaze over, but if you want a better understanding of these two ways of interpreting the data, you can read a pretty coherent explanation from Steve Simon, PhD, of Children's Mercy Hospital in Kansas City
From my view of the world (and that's why I write this blog, isn't it?) the relative risk is the number that expresses how I think about the chance that something will actually happen to one of the many individual patients for whom I have prescribed Avandia (which is almost all of the individuals living with diabetes that I have written prescriptions for over the last three years).
In this analysis it was described that there is a 43% increase in the risk of having a heart attack while taking rosiglitazone, and a 64% increase in the risk of dying from heart attack or stroke while taking this medication. These numbers are based on the odds ratio. But if you look at the actual numbers of patients who had a heart attack or died from CVD they look like this:
Total numbers drawn from 42 studies:
15,560 individuals randomly assigned to medication regimens that included rosiglitazone.
12,283 individuals randomly assigned to comparable groups that did not include rosiglitazone.
.Of those taking rosiglitazone and completing the study there were 14,371 individuals, 86 of whom had heart attacks and 39 of whom died from either these attacks or from stroke
.Of those not taking rosiglitazone and completing the study there were 11,634 individuals, 72 of whom had a heart attack and 22 of whom died from that attack or from stroke
Thus the relative risk of having a heart attack while taking rosiglitazone is 86/14,371 or 0.0059% and of death from all CVD causes is 39/14,371 or 0.0027%
By comparison, the risk of heaving a heart attack while taking a diabetes drug other than rosiglitazone is 72/11,634 or 0.0061% and of death from all CVD causes is 22/11,634 or 0.0018%
Following this line of reasoning you will note that:
the risk of having a heart attack on rosiglitazone is relatively small and the risk is nearly identical to the risk of having a heart attack while taking one of the other diabetes drugs (0.0059% versus 0.0061%).
So now how shocking does this study seem?
There is currently a study underway called the Rosiglitazone Evaluated For Cardiac Outcomes & Regulation of Glycaemia in Diabetes ("RECORD") which is going to give us additional data on the safety of rosiglitazone as measured by heart disease and stroke outcomes. Until that data is available, I am not rushing to remove my patients from rosiglitazone based on this spin on the "evidence."
Again patients are misinformed, ill-informed and don't know what to do or where to turn. I am sure that physicians are also confused as well. What hasn't helped is the vultures in the legal profession who see nothing but dollar signs while patients suffer through treatment options.
