The urgent diabetic warning the FDA refuses to sound
Riding High
We have a winner!
When the Institute for Safe Medicine Practices tallied up “serious, disabling and fatal adverse drug events” reported to the FDA in the third quarter of 2009…can you guess who came out on top?
Wait…first I’ll tell you about the runner up.
In the Number Two slot, with a whopping 977 serious adverse event reports: Seroquel, an antipsychotic drug that’s well known for its possible side effects: high blood sugar and the development of type 2 diabetes.
Very likely, quite a few Seroquel users probably ended up using Avandia–a popular type 2 diabetes medication. And coincidentally, Avandia also happens to be the drug that topped the ISMP chart!
A clear champion of serious adverse events, Avandia tallied up more than 1,200 reports in just three months. And more than 1,000 reports of patient deaths were received for Avandia in the first three quarters of 2009.
One thing you can say about this drug: It’s a model of consistency.
Most of the deaths linked to Avandia in 2009’s third quarter were caused by cardiovascular events. Which should surprise no one because the Avandia website admits straight out: “AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction).”
As we’ve seen before with the Vioxx fiasco, FDA officials barely flinch when a best selling drug racks up thousands of heart attacks. Three years ago, an FDA advisory panel concluded that, yep, Avandia might increase the risk of heart attack. In fact, the agency has actually estimated that Avandia caused 83,000 heart attacks between 1999 and 2007.
That’s enough heart attacks to fill a football stadium! But was that a problem? What? Are you kidding? GlaxoSmithKline (the maker of Avandia) was told to beef up the label warning…and have a nice day!
So you might wonder: Why does Avandia get a relatively free pass, even though the dangers are clear?
Maybe it’s Avandia’s very loyal fan base.
When a Mayo Clinic researcher reviewed more than 200 published articles about Avandia, he found that more than 85 percent of the authors who concluded that the drug DID NOT increase heart attack risk also had relationships with GSK. And some of those authors didn’t bother to disclose their GSK connection.
Well…is anyone shocked by this? Probably not.
The influence of drug money is not exactly a secret. But Avandia’s link to heart risks WAS a secret for a while.
Last month, a two-year U.S. Senate investigation concluded that GSK executives knew about Avandia’s heart risks YEARS before the evidence became public.
In other words, someone at GSK made a business decision to let the drug stay on the market. Some Avandia users might have heart attacks, and some might die. But come what may, any problems could be swept aside with enough money.
A billion dollars? Two billion? Three? No problem. Avandia made more than $3 billion in 2006 alone. Last year, sales dropped to about half the 2006 total, but still, Avandia has already made more than enough to pay off the inevitable lawsuits and still clear a generous profit.
From a bean counter’s point of view, that’s just good business.
Infuriated? Me too.
So let’s get to work, because the FDA sure isn’t going to do anything. Please help get the word out about Avandia dangers by forwarding this e-mail to anyone you know who has type 2 diabetes.
Eventually Avandia will be taken off the market. Until then, word of mouth is the only safeguard.
To Your Good Health,
Jenny Thompson
Sources:
“These Drugs Generated Most Adverse Event Reports” Ed Silverman, Pharmalot, 2/25/10, pharmalot.com
“Report: GSK Knew Avandia’s Risks for Years” CBS News, 2/20/10, cbsnews.com
“Avandia Analysis: Authors with Financial Conflicts Draw More Positive Conclusions” Nancy A. Melville, The Heart, 2/23/10, theheart.org
