Dr Jonathan Wright
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More controversy surrounding the diabetes drug Avandia
The mainstream has finally caught up with HSI again.
In 2003 we first told you about a link between the diabetes drug Avandia and an increased risk of congestive heart failure. Now, three and a half years later, the New England Journal of Medicine (NEJM) has made headlines with a study that illustrates just how expansive this danger really is.
But here's what the recent headlines haven't mentioned: Increased risk of heart attack is just part of Avandia's risk profile.
Slow going
You might wonder how the US Food and Drug Administration (FDA) responded to the NEJM study. On the very day the study was published online, FDA officials issued a safety alert. That's an impressive lightning-fast response to controversy. Meanwhile, response to safety is not quite as swift: According to an agency spokesman, the FDA has been evaluating Avandia heart risks for nearly 10 months.
And here's the frosting on the cake. Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research offered this explanation to the Associated Press: 'We've tried to weigh the risks of going forward with an uncertain message...with the level of uncertainty about the safety signal before us.'
If you happen to be fluent in FDA, please send me an e-mail to translate that message because I find it completely incomprehensible - although the parts about uncertainty come through loud and clear.
What's IS certain is that the FDA has been aware of various Avandia risks for years.
In a past e-Alert I told you about this warning posted on the FDA web site: When Avandia is taken with other oral diabetes medicines, there's a risk of 'blood sugar becoming dangerously low.'
In 2005, the agency also cautioned that 'there have been reports of inflammation of the liver (hepatitis) and elevated liver enzymes' And according to the FDA, the class of drugs that Avandia is in has been linked with 'rare but serious liver injury, including liver failure leading to transplant or death.' And: 'Avandia's liver safety profile is not fully determined yet.'
Nice. Drug companies, mainstream hacks and FDA officials give us a constant stream of inflammatory comments about fears concerning dietary supplements, while drugs like this get the reassuring stamp of 'FDA approval' and sell like hotcakes in spite of the glaring dangers.
Putting some money on it
Toward the end of the NEJM study, the authors note the 'urgent need for comprehensive evaluations to clarify the cardiovascular risks' of Avandia.
But Avandia was given FDA approval eight years ago. So what's the hold up on these evaluations? The authors state that the manufacturer of Avandia (GlaxoSmithKline) has not released complete results from clinical trials. And they add: 'The FDA also has access to study reports and other clinical-trial data not within the public domain.'
Now, if you were a gambler and you had to bet the farm on this one,would you bet that a full disclosure from GSK and the FDA would reveal a lower risk of heart attack and other problems? Or would you bet that a full disclosure might lead us down the Vioxx path, with Avandia removed from the market, a sudden deluge of lawsuits against GSK, and further confirmation that the FDA approval process is completely unreliable?
I know where my money would be.
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