GSK, FDA Knew Avandia Raised Heart Disease Risk In 2005, But Did Nothing About It

Millions of diabetics take Avandia, but is it harming them?

We live in a society that says as long as you take your pills, you can live your life however you want to. Forget about making natural changes in your diet and lifestyle to manage your health, just go hog wild living it up and let the prescription drugs take care of the consequences of those foolish actions (like the American Diabetes Association's recommendation to go ahead and eat your carbs as long as you take your diabetes medicines--UGH!).

But doing that sometimes opens you up to certain health risks as we discovered in this USA Today column about the widely-used and prescribed diabetes drug Avandia. Have you heard this shocking story yet?

It seems the manufacturer of this diabetes medicine--#2 bestselling prescription drug at GlaxoSmithKline (GSK)--informed the Food & Drug Administration (FDA) as early as 2005 of a 30-percent increase in heart disease risk for patients taking this drug. So did the FDA do their own investigation into this to confirm the safety of Avandia? Was an effort made to inform patients of this known risk?

In a word--NOPE!

Instead, it took a study published in this week's New England Journal Of Medicine to shine the light of truth on this horrific discovery that may have already quite literally negatively impacted the health of millions of Americans. You know what that means, don't you? Lawsuits out the ying yang and rightfully so. More about that in a moment.

First, let's take a look at that study for a few moments.

Lead researcher Dr. Steven Nissen (who conducted this study on statin drugs I previously highlighted at my blog) from the Cleveland Clinic wrote in his report that both GlaxoSmithKline and the FDA should have (but didn't!) take the necessary steps to adequately warn people taking Avandia of the risks to their health. Uh-oh!

Dr. Nissen concluded from his examination of 42 different studies that have been conducted on the drug posted right there on the GlaxoSmithKline web site that there was an even higher risk of heart attack--an astounding 43 percent INCREASE--as well as a spike in the risk of death from heart disease--a stunning 64 percent INCREASE!

Yikes!

These study results were eye-opening for Nissen and should be a real wake-up call for everyone who mindlessly believes you can live your life as a diabetic so long as you pop your prescription diabetes pills.

"This is important because cardiovascular disease is the leading cause of death in diabetes and is responsible for between 65% and 80% of all deaths in diabetics," he said. "The reasons we give drugs to lower blood sugar is to prevent the complications of diabetes, the most important of which is heart disease. When a drug increases that risk, it can have profound public health consequences."

Well, this study got the attention of the FDA who has NOW issued a Safety Alert this week stating there is a "potentially significant" heart health risk. Ya think?! That's mighty bold of you, FDA! It's about freakin' time!

The lapse in judgment by the FDA has compelled Congress to set up an emergency hearing by the House Oversight and Government Reform Committee on June 6th to look at this issue surrounding Avandia. Some lawmakers are already calling this "another Vioxx," referring to the now-infamous arthritis drug that had its FDA-approval yanked because of similar heart health risks.

In 2006, there were 13 million prescriptions written by doctors for their diabetic patients raking in over $2 billion (yes, that's billion with a "b")! This is big time big bucks for GlaxoSmithKline that they really hate to see go up in flames over Nissen's silly little study. So it's not surprising that they sent out the big guns to try to debunk it.

"We are confident of the safety profile of Avandia and believe in its benefit for type 2 diabetic patients," exlaimed Ronald Krall, medical director for GlaxoSmithKline, who added that there are serious flaws in how the study was conducted.

But this is something Nissen does not deny. However, he said he could only base his conclusions on the information available to him directly from the GlaxoSmithKline web site.

"It was based on an analysis of publicly available material, not patient-level data for these trials," Nissen noted. "Nevertheless, we think the results will stand up over time."

In the meantime, financial analysts are already estimating GlaxoSmithKline is gonna have to pay through the nose for the negligence despite their insistence they did nothing wrong by not revealing the heart health risks to the diabetic patients taking Avandia. How much will it cost them? Early estimates are saying the costs could end up being as much as $5 billion--that's TWO AND A HALF TIMES the sales generated by the drug in 2006 alone.

OUCH, that's gonna hurt! Wah, wah, wah! Cry me a river.

Legal experts state that there could be up to 16,000 legal claims made against GlaxoSmithKline in response to the study. At a nominal $300,000 for each case, that would add up to $4.8 billion. Additionally, Avandia sales would plummet significantly--as much as 30-40 percent.

This is exactly what you get when you rely too heavily on medicines from the big pharmaceutical companies to be your permanent lifestyle change. What do you do when that magic pill you rely on to keep you healthy actually puts you at greater risk for disease and even death? Don't you think it's time to look at all-natural changes in your diet and lifestyle to manage conditions like diabetes? If this story doesn't convince you of that truth, then I don't know what will!

Dr. Mary C. Vernon has it right about how to treat diabetes after all!