An FDA panel has voted to keep Avandia on the market. You’ve probably heard of Avandia: it’s a controversial diabetes pill made by Glaxo Smith Kline. The drug controls blood sugar levels by sensitizing the body to insulin. It used to be the world’s best selling diabetes drug after the FDA first approved its sale. By 2006 U.S. sales totaled $2.2 billion per year.
But the drug has come under heavy scrutiny since a series of studies revealed that it increases the risk of stroke. The leading study was written by heart expert Dr. Steven Nissen in 2007. He’s the chairman of Cleveland Clinic’s department of cardiovascular medicine. He reviewed 40 studies related to the drug and uncovered a shocking truth: patients taking Avandia increased their risk of heart attack by 42 percent. His findings were later published in the NewEngland Journal of Medicine.
Following these studies, sales began to drop, plummeting to $520 million last year. As sales have fallen, claims linking Avandia to increased heart risk have risen. And now they’ve snowballed into literally thousands of lawsuits against Glaxo.
The FDA clearly has its own doubts about Avandia. Its own reviewer - David Graham - presented expert data analysis at the panel meeting. He estimated that 100,000 heart problems were caused by the drug. He told the panel that Avandia will “put you in a hospital or a cemetery.”
Yet despite this, the FDA panel voted to keep the drug on the market.
“The committee vote is gravely disappointing,” says Congresswoman Rosa DeLauro. It “raises questions as to whether the science was presented in an unbiased manner.”
Original study author Dr. Nissen attended the panel meeting. He believes that the panel data still confirms the risk of stroke. He says the panel had enough data to remove the drug.
Now, the decision was by no means unanimous. Twelve of the 33 members of the panel voted to eliminate the drug. Another 10 wanted ongoing supervision of the drug. And seven suggested stronger warning labels on it.
But the panel still gave Avandia the thumbs up.
Patterns of Approval
The same thing happened in 2007 when another FDA panel first reviewed Avandia. Dr. Nissen also attended that meeting.
He said at the time that “the FDA presented patient-level analysis at the meeting. This is far more accurate when you have access to patient data. The FDA confirmed a 40 percent increase in risk. Virtually identical to our findings.”
In 2007 the FDA voted keep Avandia on the market. The New England Journal of Medicine later printed a related article. The article was written by Dr. Clifford Rosen – the man who headed up the 2007 Avandia review panel.
In his article he said that Avandia was “a new wonder drug, approved prematurely and for the wrong reasons.” He noted the FDA was “a weakened and underfunded government agency subjected to pressure from industry.” He concluded that Avandia had “caused undue harm to patients.”
And certainly Glaxo seems to know something. The 2010 ruling comes one day after the drug maker agreed to pay out $460 million to settle thousands of lawsuits. Those suits claim that Avandia caused heart attacks. Glaxo is quietly settling over 10,000 suits for $46,000 each.
Opting for the Safe Solution
Data suggests that Avandia may increase stroke risk. But the FDA approves it because it also does some good. That’s because it increases your sensitivity to insulin.
But THB panel expert Michael Cutler M.D. says there are many safer ways to do that.
“I was never taught any measures for my patients,” says Dr. Cutler, a board-certified physician with over 17 years of experience. “It baffles me that I couldn’t see the gap in my medical training. We did nothing to prevent diabetes.”
Many years have passed since Dr. Cutler graduated from med school. He’s spent years in practice since then. He’s also continued his own private research and learning. And he knows that modern medicine is missing the point.
“Conventional medicine today is still all about using drugs to lower blood sugar,” says Dr. Cutler. That’s “too late if you want to reverse the disease.”
The secret instead lies in what you eat. A healthy low-carb, low-sugar diet balances your blood sugar. And there are many tools to improve your diet.
For one thing, Dr. Cutler says herbs are a safe way fight diabetes. That’s because they can lower your blood sugar levels.
“I have been using Bio PT Elixir for about two-and-a-half months.”
After using THB’s new health-boosting supplement, Bio PT Elixir, Cynthia M. wrote in to tell us exactly how it had impacted her health:
“I purchased it because of the high content of antioxidants and phytonutrients it contains derived from grapes, various berries, and green tea. The fact that it has potassium and magnesium in it was also a deciding factor. I felt that the high concentration of nutrients would be excellent to help with free-radical damage to the body, and might be beneficial to ward off aches and pains associated with aging.
“It tastes good, and is easy to swallow. My energy level seems to be somewhat improved, and my muscle aches seem to have diminished quite a bit.
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Your Herbal Path to Better Health
Dr. Cutler says herbal remedies can really make a difference to your health. They can work better than drugs and are a lot safer. The following seven herbs are backed up by solid scientific evidence in multiple studies. Dr. Cutler says these seven herbs will help control your blood sugar levels.
Green tea. It’s an old favorite and a good health promoter. One study reveals that green tea increases insulin activity. That’s thanks to its active ingredient, EGCG.
Cinnamon. Diabetes Care reports that cinnamon kicks up sugar metabolism. Sixty diabetics took a half teaspoon of cinnamon every day for 40 days. Researchers reported major drops in blood sugar levels.
Ginseng root. Several studies have tested Ginseng as a treatment for diabetes. One study showed a big drop in sugar versus placebo in Type II diabetes.
Milk thistle. Milk thistle cleanses the liver, which fights diabetes. Doses of over 1,500 mg increase bile flow and secretion. “This desired effect makes it the herb of choice for any liver-related diseases,” says Dr. Cutler.
Devil’s claw. Devil’s claw may have insulin-like elements. However, Dr. Cutler notes that research is ongoing.
Bilberry. Studies show that bilberry leaves also lower blood sugar levels. This is no news to country folk. They’ve been using it in “anti-diabetic” teas for years.
Fenugreek. A major study showed it greatly lowered blood sugar levels.
[Ed. Note: Michael Cutler, M.D. is a board-certified family physician. He has over 17 years of clinical experience. He is a graduate of Brigham Young University and Tulane Medical School. Dr. Cutler's practice focuses on solutions to health problems. He focuses on behavioral and nutritional medicine. For information, visit www.truehealth.com .]
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