August Cranky Yankee Newsletter
Avandia Warnings from House Calls by Dr. Alan Inglis
When the cure is worse than the disease
It's always with a sinking feeling that I tell you about the less-than-stellar results of drugs that have been out on the market for a while, because I realize those negative findings represent real folks who took those drugs in good faith. They followed doctor's orders to manage their diseases-and didn't understand that they were being used as guinea pigs.
A case in point involves the two popular drugs prescribed for type 2 diabetes. You've probably seen the headlines proclaiming that patients who are on either of these drugs are twice as likely to develop heart failure. Out of every 50 patients on either of these drugs, one will develop heart failure within 26 months.
There are more than 3 million diabetic patients in this country who are taking one of these prescriptions. Do the math. That's an unacceptable number of people being put at risk for heart failure.
Worse is the recent review that discovered Avandia's risks were higher than that of Actos-which I'll talk about in a minute.
While researchers knew there was a risk of heart failure associated with these drugs, they report that they didn't realize the extent of that risk. Nor, they say, did they know that the risk could occur even in the lowest dose given and among younger patients.
The risk also extends beyond patients on insulin and includes folks who were not flagged for any other heart-failure-risk factors. And even though Actos was not off the hook for higher risks, it was considered safer for insulin users compared to Avandia.
Researchers attribute the increased risk to the probability that the drugs cause fluid retention.
Unbelievably, the FDA's initial response was to dicker around, kick the dirt, and wonder if the "benefits outweigh the risks."
Apparently in its eyes, they do. But you have to read "benefits" as "profits" and "risks" as "lives."
The debate goes on about Avandia.
You have its maker, GlaxoSmithKline, kicking the ball back to the FDA regarding these newly found risks associated with their product. Take a look at this paragraph directly from the company's web site:
For some people taking Avandia, possible side effects include heart failure or other heart problems. Further information regarding potential heart-related risks is currently under review by the FDA. Talk to your doctor as FDA has made information on potential heart-related risks available to physicians on its website at www.fda.gov.
And a spokesperson for the company reportedly responded to the news of the increased risk of heart failure associated with Avandia by saying the company continues to believe in its safety. (What about Santa Claus and the Tooth Fairy?)
Bickering and bull surround fate of diabetes drug
A federal drug-advisory committee got together to discuss the question of what to do about Avandia. By some appearances, it would seem that not everyone in the FDA is on the company bandwagon.
The dissenters were outnumbered, and I wasn't surprised to learn that the Big Pharma toadies won the day. They voted to recommend that the popular diabetes drug should remain on the market, despite strong evidence of its increasing heart-attack risk for diabetic patients.
I'm resigned to the fact that these FDA folks would say that the sun is a lukewarm star if their drug-company pals told them to say it. They seem to have absolutely no shame. Their justification for keeping this now more-than-questionable drug on the market? They thought that the recent studies about Avandia's inherent cardiovascular-disease risks were just too sketchy to justify yanking the drug from the market.
As I relayed to you in House Calls a couple of weeks ago, one out of every 50 patients on either Avandia or Actos will develop heart failure within 26 months. To hammer home the point that the drug is dangerous, one of the dissenters on the panel cited an estimate based on recently released studies that Avandia caused over 200,000 heart attacks and strokes over a seven-year period.
I hardly consider 200,000 heart attacks and strokes-some of them resulting in death-to be just a vague detail that can easily be dismissed! Also, bear in mind that there are many diabetics who suffer a host of health problems that can complicate even further their attempts to cope with various side effects of their disease. Now many of them take a pill that is supposed to help them but could kill them instead.
In addition, the same FDA dissenter I mentioned above estimates that for every month Avandia remains on the market 1,600 to 2,200 patients will be at risk of a heart attack or stroke.
It also seems that the FDA and GlaxoSmithKline hadn't communicated previously in order to keep their stories straight. The FDA reports that the drug company told it about these risks but that because of internal debate within the FDA (read: their fear of GlaxoSmithKline), the information never got into the hands of doctors and their patients. Meanwhile, GlaxoSmithKline continues to deny any problems with its drug.
GlaxoSmithKline, while on the one hand vehemently denying that there are any safety issues with Avandia, agreed on the other to add a "black-box" warning on the drug's label regarding the increased cardiovascular risk.
It was also revealed through agency records that Avandia has additional risks associated with it, such as liver failure and an increased risk of fractures.
But I'll bet you won't hear much about that for a while.
In the meantime, skip Avandia. There are other, safer ways to manage your diabetes. I recommend a heart-to-heart talk with your doctor. Frankly, there are very few cases of Type 2 diabetes that don't respond to careful diet and regular, vigorous exercise (including strength training with weights). Otherwise, in my opinion, metformin (Glucophage) is the preferred oral agent for diabetes. But please keep in mind that it can cause a loss of vitamins B12, folate and Coenzyme Q10, so you may need to supplement extra amounts of those nutrients.
Recipe of the Month: Quick and Easy Chocolate Pudding
A man rubbed a lamp and a genie popped out. “I can only give you one wish,”
said the genie, “so make it a good one.” The man thought for a minute and said, “Make me irresistible to women.” The genie smiled and said, “Poof, you’re a box of chocolates!”
Tools: measuring cups and spoons, mixing spoon, whisk, medium microwaveable bowl, microwave.
Ingredients:
¼ cup unsweetened cocoa powder
2 tablespoons cornstarch
1½ cups 2% milk
Sugar substitute equal to 1/3 cup sugar
1 teaspoon vanilla extract
1/8 teaspoon ground cinnamon (optional)
Directions:
Combine cocoa powder and cornstarch in the medium microwaveable bowl. Gradually whisk in the milk until mixture is well blended.
Microwave on high 2 minutes, then stir. Continue microwaving at medium-high (70% power) 3 to 4½ minutes or until thickened-stir every 1½ minutes.
Stir in sugar substitute, vanilla, and cinnamon (if desired). Let the pudding stand at least 5 minutes before serving. Stir occasionally to prevent a skin from forming on the top. Can be served warm or chilled.
Makes 4 servings @ approx. 80 calories each
When the cure is worse than the disease
It's always with a sinking feeling that I tell you about the less-than-stellar results of drugs that have been out on the market for a while, because I realize those negative findings represent real folks who took those drugs in good faith. They followed doctor's orders to manage their diseases-and didn't understand that they were being used as guinea pigs.
A case in point involves the two popular drugs prescribed for type 2 diabetes. You've probably seen the headlines proclaiming that patients who are on either of these drugs are twice as likely to develop heart failure. Out of every 50 patients on either of these drugs, one will develop heart failure within 26 months.
There are more than 3 million diabetic patients in this country who are taking one of these prescriptions. Do the math. That's an unacceptable number of people being put at risk for heart failure.
Worse is the recent review that discovered Avandia's risks were higher than that of Actos-which I'll talk about in a minute.
While researchers knew there was a risk of heart failure associated with these drugs, they report that they didn't realize the extent of that risk. Nor, they say, did they know that the risk could occur even in the lowest dose given and among younger patients.
The risk also extends beyond patients on insulin and includes folks who were not flagged for any other heart-failure-risk factors. And even though Actos was not off the hook for higher risks, it was considered safer for insulin users compared to Avandia.
Researchers attribute the increased risk to the probability that the drugs cause fluid retention.
Unbelievably, the FDA's initial response was to dicker around, kick the dirt, and wonder if the "benefits outweigh the risks."
Apparently in its eyes, they do. But you have to read "benefits" as "profits" and "risks" as "lives."
The debate goes on about Avandia.
You have its maker, GlaxoSmithKline, kicking the ball back to the FDA regarding these newly found risks associated with their product. Take a look at this paragraph directly from the company's web site:
For some people taking Avandia, possible side effects include heart failure or other heart problems. Further information regarding potential heart-related risks is currently under review by the FDA. Talk to your doctor as FDA has made information on potential heart-related risks available to physicians on its website at www.fda.gov.
And a spokesperson for the company reportedly responded to the news of the increased risk of heart failure associated with Avandia by saying the company continues to believe in its safety. (What about Santa Claus and the Tooth Fairy?)
Bickering and bull surround fate of diabetes drug
A federal drug-advisory committee got together to discuss the question of what to do about Avandia. By some appearances, it would seem that not everyone in the FDA is on the company bandwagon.
The dissenters were outnumbered, and I wasn't surprised to learn that the Big Pharma toadies won the day. They voted to recommend that the popular diabetes drug should remain on the market, despite strong evidence of its increasing heart-attack risk for diabetic patients.
I'm resigned to the fact that these FDA folks would say that the sun is a lukewarm star if their drug-company pals told them to say it. They seem to have absolutely no shame. Their justification for keeping this now more-than-questionable drug on the market? They thought that the recent studies about Avandia's inherent cardiovascular-disease risks were just too sketchy to justify yanking the drug from the market.
As I relayed to you in House Calls a couple of weeks ago, one out of every 50 patients on either Avandia or Actos will develop heart failure within 26 months. To hammer home the point that the drug is dangerous, one of the dissenters on the panel cited an estimate based on recently released studies that Avandia caused over 200,000 heart attacks and strokes over a seven-year period.
I hardly consider 200,000 heart attacks and strokes-some of them resulting in death-to be just a vague detail that can easily be dismissed! Also, bear in mind that there are many diabetics who suffer a host of health problems that can complicate even further their attempts to cope with various side effects of their disease. Now many of them take a pill that is supposed to help them but could kill them instead.
In addition, the same FDA dissenter I mentioned above estimates that for every month Avandia remains on the market 1,600 to 2,200 patients will be at risk of a heart attack or stroke.
It also seems that the FDA and GlaxoSmithKline hadn't communicated previously in order to keep their stories straight. The FDA reports that the drug company told it about these risks but that because of internal debate within the FDA (read: their fear of GlaxoSmithKline), the information never got into the hands of doctors and their patients. Meanwhile, GlaxoSmithKline continues to deny any problems with its drug.
GlaxoSmithKline, while on the one hand vehemently denying that there are any safety issues with Avandia, agreed on the other to add a "black-box" warning on the drug's label regarding the increased cardiovascular risk.
It was also revealed through agency records that Avandia has additional risks associated with it, such as liver failure and an increased risk of fractures.
But I'll bet you won't hear much about that for a while.
In the meantime, skip Avandia. There are other, safer ways to manage your diabetes. I recommend a heart-to-heart talk with your doctor. Frankly, there are very few cases of Type 2 diabetes that don't respond to careful diet and regular, vigorous exercise (including strength training with weights). Otherwise, in my opinion, metformin (Glucophage) is the preferred oral agent for diabetes. But please keep in mind that it can cause a loss of vitamins B12, folate and Coenzyme Q10, so you may need to supplement extra amounts of those nutrients.
Recipe of the Month: Quick and Easy Chocolate Pudding
A man rubbed a lamp and a genie popped out. “I can only give you one wish,”
said the genie, “so make it a good one.” The man thought for a minute and said, “Make me irresistible to women.” The genie smiled and said, “Poof, you’re a box of chocolates!”
Tools: measuring cups and spoons, mixing spoon, whisk, medium microwaveable bowl, microwave.
Ingredients:
¼ cup unsweetened cocoa powder
2 tablespoons cornstarch
1½ cups 2% milk
Sugar substitute equal to 1/3 cup sugar
1 teaspoon vanilla extract
1/8 teaspoon ground cinnamon (optional)
Directions:
Combine cocoa powder and cornstarch in the medium microwaveable bowl. Gradually whisk in the milk until mixture is well blended.
Microwave on high 2 minutes, then stir. Continue microwaving at medium-high (70% power) 3 to 4½ minutes or until thickened-stir every 1½ minutes.
Stir in sugar substitute, vanilla, and cinnamon (if desired). Let the pudding stand at least 5 minutes before serving. Stir occasionally to prevent a skin from forming on the top. Can be served warm or chilled.
Makes 4 servings @ approx. 80 calories each
posted by Mrs.Cranky Yankee @ 12:00 PM
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