According to the New York Times' live blogging from the F.D.A. hearing on Avandia, the votes are in and it's not looking good for GlaxoSmithKline.

Of the 33 members of the committee, only three voted in favor of keeping Avandia on the market as is. Seven advocated adding more warnings on the drug; ten votes went to restricting its sale or making significant revisions to the label, and twelve committee members voted to take Avandia off the market altogether. The F.D.A. will make a final decision "at a later date."

Avandia Update: F.D.A. Votes In originally appeared on About.com Diabetes on Wednesday, July 14th, 2010 at 17:24:01.

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A New York Times article published today makes the scandalous revelation that SmithKline Beecham (now called GlaxoSmithKline) conducted a study on its new diabetes drug, Avandia, in 1999, and has been working to hide the findings from the public for the past 11 years.

The 1999 study found that Avandia was not only no more effective than its competitor, Actos, but also that it presented more risks of heart attack and stroke. The Times published the following excerpt from an email written in 2001 by SmithKline executive Dr. Martin I. Freed:

"This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK."

To make matters worse, it seems that Dr. John Jenkins, head of the F.D.A.'s office of new drugs, has been rooting for Avandia, speaking out against taking it off the market, and "disciplining" an employee who recommended that the health warnings be strengthened for Avandia.

Data on Avandia Hidden from the Public Since 1999 originally appeared on About.com Diabetes on Tuesday, July 13th, 2010 at 16:38:21.

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We've known since 2007 that Avandia, once the world's most popular diabetes drug, may increase risk of stroke and heart attack. Two new studies further confirm the suspicions raised three years ago. The FDA plans to meet in July to finally decide whether or not to take Avandia off the market.

The larger of the two studies, commissioned by the FDA and published in the Journal of the American Medical Association, followed 230,000 Medicare patients who were taking either Avandia or a comparable drug called Actos. The results, study leader Dr. David Graham told NPR, indicate a frightening probability: "If you treated 60 people for a year with Avandia," he says, "you would cause one extra case of heart attack, stroke, heart failure or death compared to if you had treated 60 patients with Actos." By the same token, Graham says, approximately 100,000 Americans have likely died or had strokes, heart attacks or heart failure as a result of taking Avandia since it went on the market in 1999.

A meta-analysis of dozens of studies that came out in 2007 found the same results as these most recent studies, yet the FDA's Drug Safety Oversight Board voted 8-7 to keep Avandia on the market. What do you think? Has the FDA failed to learn the lesson posed by the Vioxx scandal in 2004? Or are they right to proceed with caution before pulling a product from the market?

FDA May Finally Nix Avandia originally appeared on About.com Diabetes on Tuesday, June 29th, 2010 at 11:25:13.

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A new game on Facebook challenges you to improve your diet and lifestyle with your virtual friends as witnesses (and hopefully supporters). HealthSeeker, developed by Diabetes Hands Foundation and Joslin Diabetes Center, involves things called "Missions" and "Action Steps," which you must complete in order to advance in the game and ultimately achieve several "Lifestyle Goals," like eating more healthily, reaching a particular weight, reducing blood sugar levels and improving heart health. Players report on their progress and receive points, badges and awards for their hard work. The game can be found at www.healthseekergame.org.

What do you think? Does HealthSeeker seem like a legitimately helpful way to improve your habits and manage your health, or is it just yet another way to reveal too much personal information on Facebook? Share your thoughts below.

Manage Your Diabetes...On Facebook? originally appeared on About.com Diabetes on Tuesday, June 22nd, 2010 at 12:53:34.

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The American Heart Association, the American Diabetes Association, and the American College of Cardiology just updated their recommendations on the use of aspirin in patients with diabetes.

The new recommendation: Low-dose aspirin is an appropriate and effective prophylactic method for diabetes patients with certain cardiovascular disease risks. Who are those folks? Mostly patients over 50 (men) or 60 (women), with one or more risk factors for a vascular event. (Risk factors include smoking, hypertension, and a family history of heart disease, among other things.) The new advice says that if patients are diabetic with few or no risk factors for vascular disease, they probably won't benefit from taking aspirin. This is a change to the earlier recommendation, which stated that diabetes patients over 40 with one risk factor for cardiovascular disease should take aspirin.

So what does this mean for you? It may mean that you're no longer in the group advised to take aspirin to prevent heart trouble. Consult with your doctor to find out more and draft a new action plan for your health.

New Criteria for Aspirin Use in People With Diabetes originally appeared on About.com Diabetes on Friday, May 28th, 2010 at 15:30:24.

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If you're taking Metformin -- an oral medication used to treat type 2 diabetes also known by its brand names Fortamet, Glucophage, Glumteza, Glucophage XR, Riomet and Avandamet -- you might want to consider checking your B12 levels.

A four-year study of 390 patients with type 2 diabetes at Maastricht University Medical Center in the Netherlands found that those taking the drug had a 19% reduction of vitamin B12 levels over time, while those given the placebo showed no notable change in B12 levels.

Vitamin B12, which is essential for neurological function and red blood cell formation, among other things, occurs naturally in many foods and can also be taken in pill form. Symptoms of a B12 deficiency include weakness, fatigue, loss of appetite, constipation, and neurological changes like numbness in the hands and feet.

Metformin linked to B12 deficiency originally appeared on About.com Diabetes on Monday, May 24th, 2010 at 16:13:02.

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National drugstore chain CVS is appealing to the approximately 21 million Americans with diabetes this month, offering free A1C tests at select locations through June 12th. The pharmacy has also introduced the ExtraCare Advantage for Diabetes program, which promises discounts on the purchase of diabetes supplies to those who sign up, as well as advice from pharmacists on how to reduce your treatment-related costs. Publicity stunt? Absolutely. But who are we to look a gift horse in the mouth?

CVS Reaches Out to Diabetes Patients originally appeared on About.com Diabetes on Wednesday, May 12th, 2010 at 11:51:07.

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National drugstore chain CVS is appealing to the approximately 21 million Americans with diabetes this month, offering free A1C tests at select locations through June 12th. The pharmacy has also introduced the ExtraCare Advantage for Diabetes program, which promises discounts on the purchase of diabetes supplies to those who sign up, as well as advice from pharmacists on how to reduce your treatment-related costs. Publicity stunt? Absolutely. But who are we to look a gift horse in the mouth?

CVS Reaches Out to Diabetes Patients originally appeared on About.com Diabetes on Tuesday, May 11th, 2010 at 11:55:49.

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Yet another reason to get to bed earlier: A small study of nine people at Leiden University Medical Center in the Netherlands found that a single night of bad sleep can negatively affect the body's ability to use insulin, the hormone that controls glucose sugar. While further studies are necessary, researchers are speculating that there could be a connection between Westerners' increasingly poor sleep habits and the uptick in instances of adult-onset diabetes. Adults typically need between seven and nine hours of sleep per night.

Lack of Sleep Linked to Blood Sugar Levels originally appeared on About.com Diabetes on Wednesday, May 5th, 2010 at 13:06:31.

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In January of this year, the FDA approved a new drug for treatment of type 2 diabetes. Victoza (liraglutide) is a once-a-day injection that helps to control blood sugar levels. It is a glucagon-like peptide-1 (GLP-1) receptor agonist that promotes insulin production in the pancreas when digestion occurs.

The FDA says that Victoza should not be used as a first-line therapy for patients whose blood sugar is not controlled through diet and exercise.

There are some safety considerations associated with use of Victoza. Increased incidence of pancreatitis was noticed during clinical trials of the drug. Of 3,900 people tested on Victoza, seven developed pancreatitis. There was only one occurrence of pancreatitis, in patients using a different diabetes drug.

But more troubling is the apparent risk of medullary thyroid cancer that may be associated with use of Victoza. During clinical trials, mice developed this rare form of thyroid cancer when given 8 times the dose of Victoza. This may or may not indicate that thyroid cancer in humans is a risk. More testing is needed to determine that fact.

According to a press release from the FDA, "the agency is requiring the manufacturer of Victoza to conduct a 5-year epidemiological study using a large healthcare claims database to compare the development of thyroid cancer among patients with T2DM who use Victoza to those who are not using this medicine."

A 15 year study will also be initiated to monitor cases of thyroid cancer in people who take Victoza.

Why was this drug approved? The FDA believes that the benefits for people with type 2 diabetes outweighs the side effects of the drug. How do you feel about this? Hit the comment button below and tell us how you feel.

New Drug for Type 2 Diabetes Has Some Safety Issues originally appeared on About.com Diabetes on Wednesday, March 24th, 2010 at 21:33:38.

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