Thursday, July 29, 2010

Avandia study goes ahead despite the serious dangers linked to this diabetes drug

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29 July 2010

UK Edition

Dear Reader,

Avandia's sure been taking a beating in the news lately.

The latest is GlaxoSmithKline's settlement with almost 700 people who say they suffered heart attacks, strokes, or congestive heart failure after taking Avandia. Among the 700 are people fighting on behalf of beloved family members who died.

And, of course, you've been reading all about the ongoing bad news for Avandia in the e-Tips. Questions about researchers' and doctors' financial ties, Avandia's links to bone fracture, high risk of heart attack, and other major (even deadly) health risks, calls for Avandia to be pulled from the market for good...

Yet despite all this bad news, Avandia just won't quit. A major global trial of the drug is still chugging along. In 2007, the American Food and Drug Administration (FDA) asked GlaxoSmithKline to compare the long-term heart effects of Avandia with those of rival drug Actos. You see, evidence had started popping up, showing that Avandia increased the risk of heart attack and chest pain.

So the FDA wanted to know if it was worth keeping Avandia around if another drug could do the same job with less risk. Why they had to put more people at risk through this trial is beyond me – more and more data has been linking Avandia to major health risks.

Of course, people want the trial to stop. Science-based consumer advocacy group Public Citizen is calling for a halt. Their Health Research Group has been keeping an eye on Avandia – and they don't like what they see.

They say a "wealth of data" suggests that Avandia carries greater risk than Actos, and that the patients enrolled in this trial (known as TIDE) aren't actually fully informed about the safety differences before they agree to play guinea pig.

Public Citizen is calling for an immediate halt of the TIDE trial. Don't make me laugh – when was the last time you saw the FDA do anything "immediate"?

They say it's enough that they're already taking a close look at Avandia. Of course, their own reviewers called for Avandia to be removed from the market, but I suppose they've forgotten that little detail.

They plan to discuss the TIDE trial in July, when they will reassess the trial's rationale and review its enrolment. They say they're reviewing everything they currently have, but just can't reach any new conclusions. Of course, to everyone else, the conclusions are clear.

Could it have something to do with Glaxo's insistence on standing by this potentially killer drug (or the fact that the American Heart Association – despite all the evidence – says we need more trials)? A spokeswoman for Glaxo had Avandia's back in a statement, saying it's an "important treatment option" and that doctors often have to prescribe two or three medicines to control patients' blood sugar, but that Avandia can control blood sugar for up to five years! Five years! What she suggests you do after that... well maybe that's when you start taking six or seven drugs.

Multiple drugs to control one health condition – even Big Pharma's most enthusiastic supporters are admitting their drugs don't really work. Yet they insist upon keeping them on the market, and willingly march people into harm's way to prove the impossible. Of course, they'll find a way to smooth out the data, pay off a few doctors, and Avandia will come out looking a-okay. Until we uncover the next cover-up. We've seen all the evidence, and now it's time to get behind groups like Public Citizen and put an end to this farce.

Continues below...


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Bear in mind we are not addressing anyone's personal situation and you should rely on this for informational purposes only. Please consult with your own doctor before acting on any recommendations contained herein.

Wishing you the best of health,

Andrew Miller
UK Editor


In the latest issue of Nutrition & Healing, Dr Jonathan V. Wright will tell you about the small fruit that could prove to be a huge threat to Big Pharma. Discover the remarkable root-plant that can bring much-needed relief from nausea for pregnant women and cancer patients. Also, learn why bacon and eggs could be your 'new' healthy breakfast.

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Sources:

"Glaxo settles hundreds of Avandia suits: lawyer," Reuters (reuters.com)

"U.S. group urges FDA to halt Glaxo's Avandia trial," Reuters (reuters.com)

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