posted November 26, 2007 10:03 PM         

(NewsTarget) The former deputy director of the FDA's Division of Drug Risk Evaluation has said that she was verbally reprimanded by her superiors when she recommended that diabetes drug Avandia be labeled with a "black box" warning about congestive heart failure.

Rosemary Johann-Liang, who left her position on June 8, said that she followed her staff's recommendation in February 2006 and asked for the black box warning, the strongest warning that the FDA can issue for a medication without banning it. In response, Johann-Liang was scolded and told to check with her director before making any further major drug safety recommendations.

In response to new studies linking Avandia to increased risks of cardiovascular disease and congressional inquiries into the FDA's process for approving the drug, the agency is now asking for black box warnings on both Avandia and related drug Actos.

Johann-Liang has criticized the FDA for demanding a higher standard of proof that a drug is unsafe than it requires to prove a drug effective. For diabetes drugs, for example, the agency only requires proof that the drug lowers blood sugar, but none that it improves the quality or length of patients' lives. In contrast, the FDA is very resistant to hearing that there might be risks associated with a drug.

"I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems," Johann-Liang said. "I think, in general, there's a culture of 'the drug is always innocent.'"

This has led, she says, to serious safety problems, and "people are continuing to be hurt." Johann-Liang is concerned that patients taking Avandia may attribute congestive heart failure symptoms to their diabetes, and actually take more of the drug that is causing the problem.

"Despite existing warnings, these drugs [have continued to be] prescribed to patients with significant heart failure," said FDA Commissioner Andrew von Eschenbach.

posted November 27, 2007 02:51 AM         

Page Count: 67 pgs + bonuses
Author: Mike Adams, Health Ranger

The following items are included FREE with this product:

1 of Breakfast Breakthrough ($9.95 value!) 1 of The Top Five Grocery Shopping Tips for Diabetics ($9.95 value!)






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Welcome to the down-to-Earth guide on beating type-2 diabetes. Five years ago, I used to be borderline diabetic. I weighed 220 pounds, suffered from severe carbohydrate cravings, mood swings, and depression. Using the very same natural health strategies revealed here, I beat diabetes and hyperinsulinemia and today maintain a steady blood sugar level of 87, without drugs or insulin.
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* The one common cause of diabetes, mood swings and irritability.
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This isn't some miracle cure
If all this sounds too good to be true, let me remind you that this is no effortless, miracle cure. It requires the application of specific health strategies that you will no doubt find challenging in terms of breaking old habits. And not everybody can accomplish this in 25 days. For most people, in fact, it will take longer. For some, it may take 25 weeks! But as long as you're making forward progress, that's what counts. And with this guide, you'll have all the information you need to keep making forward progress, day after day, bringing you one step closer to a life without this devastating disease. It's not important how long it takes... what's important is that now you have the key to halting your diabetes. This is the information you never received from conventional medicine.
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The Top Five Grocery Shopping Tips for Diabetics was designed to help you navigate this nutritional minefield and get the information you need to choose groceries that will help you manage your diabetes. Depending on the progression of your disease, this information may even help reverse or eliminate the onset of adult type 2 diabetes. This bonus guide, valued at $9.95, is yours free with your purchase.
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