(October 11 2010) A September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems.
The FDA is restricting access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy, or REMS.
Under the ruling, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons.
Current users of Avandia will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns.
But did the FDA go far enough -- could it be too little, too late?
Unlike the US FDA, British regulators have ruled that GlaxoSmithKline's diabetes drug Avandia could lead to heart attacks or strokes, and benefits no longer outweigh the risks.
And so last week, they told 90,000 British diabetes patients to stop taking it.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007, and GSK has agreed to pay $460 million in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks. But the US FDA has chosen only to monitor the drug, rather than ask for a recall.
Sources:
New England Journal of Medicine September 23, 2010
Philly.com June 17, 2010
The Guardian 23, 2010
Philly.com September 23, 2010
Dr. Mercola's Comments:
Like Vioxx, the case of Avandia has turned into yet another classic example of what is fundamentally wrong with the conventional medical paradigm.
Diabetes has increased more than 700 percent in the last 50 years. Today, more than one in four Americans are either pre-diabetic or have full-blown diabetes.
In response, conventional medicine offers up drugs that in no way, shape or form treat the cause of the problem, and worse yet, can prematurely kill many of those who take them.
The drug in question here, rosiglitazone, is sold under the names of Avandia, Avandamet and Avaglim. Avandia alone is used by 2 million people worldwide.
But other diabetic drugs are not necessarily any safer. Two years ago I wrote about Byetta, an "add-on" drug for diabetes (meaning it's usually prescribed in combination with other drugs) that can cause acute and in some cases lethal pancreatitis.
The saddest part about this debacle is that type 2 diabetes is not only a completely avoidable disease, but also one that in nearly all cases can be successfully reversed without ever touching a drug.
The only thing rosiglitazone drugs like Avandia do is to help lower blood glucose, which has virtually no influence on the long-term damage due to type 2 diabetes. Most of the damage is caused by elevated insulin levels, which can be remedied with an optimal diet and exercise program alone, if you're compliant.
Another aspect of this story that makes Avandia such a poster child for this lethal paradigm is the fact that GlaxoSmithKline, the manufacturer of Avandia, hid damaging information about the drug for over ten years, as it would adversely affect their sales!
Again and again we are confronted with indisputable evidence that the drug paradigm is about money, not health.
Between 1999 and 2007, Avandia is estimated to have caused 83,000 unnecessary heart attacks. This is a steep price, to say the least, for a disease that does not require drugs to begin with.
This is 20,000 more deaths than Merck caused when they sold Vioxx.
European Medicines Agency Bans Avandia
Avandia hit the market in 1999 and quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion. By 2009, sales had dropped to $1.2 billion following a damning study published in the New England Journal of Medicine (NEJM) in 2007, which linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods.
Unfortunately, a committee of independent experts recommended that Avandia remain on the US market, despite its risks, and an FDA oversight board voted 8 to 7 to accept the advice.
Since that 2007 NEJM study, data from various trials, studies and meta-analyses have consistently confirmed the dangers of this drug, and based on the evidence amassed over the past three years, the European Medicines Agency is now recommending the withdrawal of rosiglitazone-containing diabetic drugs due to the increased risk of ischaemic heart disease.
Their recent press release states that,
"...the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorization of the medicines.
Europe will cease all prescriptions of these drugs within the next few months.
American patients, however, will not receive the same protection from the US FDA.
The September 23, 2010 article in NEJM explains:
"Following an advisory committee meeting held in July 2007, the U.S. Food and Drug Administration (FDA) added information about the possibility of ischemic cardiovascular risk to the drug’s existing boxed warning. At the same time, the FDA also required the sponsors to conduct a head-to-head cardiovascular safety trial of rosiglitazone versus pioglitazone — the other antidiabetic drug in this class available in the United States.
After new data became available, the FDA held a second advisory committee meeting on rosiglitazone safety on July 13 and 14, 2010. On September 23, 2010, the FDA announced regulatory actions stemming from these deliberations.”
The regulatory actions we'll see in the US includes restricting access to these drugs, but they’re STILL not being taken off the market.
Current users are supposed to be informed of the dangers and sign off that they understand the risks, but can otherwise continue taking it "if they appear to be benefitting from it." New patients are only supposed to be offered the drug if they're unable to control their diabetes using some other form of medication.
So, while the European agency determined that there is no way of reducing the cardiovascular risks involved if you’re on this drug, and that its risks outweigh its benefits, the US FDA is still vacillating on this issue.
They seem completely incapable of determining whether or not the lives of tens of thousands of people are more valuable than the corporate profits that feed the agency...
Why is that?
NEJM also points this out, stating that:
"The rosiglitazone controversy is remarkable because there are strongly held, differing positions on how the agency should respond to emerging safety data, both inside the FDA and in the biomedical community.
The 2010 advisory committee was split in advising the agency about what to do. Moving from the least to most restrictive options, 3 members voted to allow continued marketing with no changes to the label; 7 voted that the FDA should adjust the label to account for the new concerns but take no additional action; 10 members voted for the FDA to both increase warnings and limit access to rosiglitazone; and 12 voted that the medication should be removed from the market altogether.
The FDA decided to increase warnings and limit access to rosiglitazone substantially."
The fact that ANYONE would be callous enough to vote to continue marketing Avandia with little or no change in strategy whatsoever is astounding to me. Yet there were plenty of voices speaking FOR the continuation of insane greed.
That in and of itself speaks volumes about the FDA’s lack of concern for your well-being...
NEJM also hits the nail on its head with the statement that, "the case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term."
Amen to that.
But I believe we need to go even further, and re-educate people about their need for such pills in the first place. The drug industry has been able to manipulate the medical industry and most consumers into believing their drugs are the answer to the problem.
Unfortunately, in the vast majority of cases, taking the drug route will lead you further and further away from health, and closer to ever more serious health problems.
Diabetes in particular is a perfect example of a health problem best treated without drugs -- if you ever want to get well, that is.
So please understand, you cannot successfully treat the underlying cause of diabetes with drugs!
MOST DIABETIC RECOMMENDATIONS ARE DEAD WRONG
And I do mean dead, literally, as they are prematurely killing millions with their flawed insights into basic human physiology.
It's sad but true -- most conventional recommendations for diabetics are seriously flawed and if you follow them, you will likely experience increased health problems and premature death.
First and foremost, you must understand that diabetes is NOT a blood sugar disease like your doctor may have led you to believe. Rather, type 2 diabetes is a disease caused by insulin resistance and faulty leptin signaling, both of which are regulated through your diet.
Listen, the evidence is crystal clear. Regarding Avandia, there is NO REASON for ANYONE to take this drug for diabetes. It has already killed over 80,000 people and does nothing to ameliorate the side effects of diabetes or prevent its complications because it does nothing to address the cause.
It is simply CRIMINAL that this drug is still on the market.
If you or anyone you know is still taking this drug you must warn them of this danger. This is literally a life and death situation. Tell them there are simple, inexpensive, and in many cases free, ways to treat diabetes that actually work and do not kill them.
I discuss these strategies below.
Why You MUST Restrict Fructose Consumption
If You Want to Avoid or Treat Diabetes
If you want to successfully address your diabetes, or avoid it in the first place, you simply must address your fructose consumption. Your body metabolizes fructose differently from glucose and these differences lead to serious health consequences, one of which is diabetes.
For example, fructose does not stimulate a rise in leptin, so your satiety signals are diminished. It also reduces the amount of leptin crossing your blood-brain barrier by raising triglycerides. And whereas glucose suppresses ghrelin (the hunger hormone, which makes you want more food), fructose does not.
Fructose also increases your insulin levels, interfering with the communication between leptin and your hypothalamus, so your pleasure signals aren’t extinguished. Your brain senses starvation and prompts you to eat more.
All of this also sets the stage for over indulgence and hence overweight, and puts you on the path toward both obesity and diabetes.
I strongly advise keeping your fructose consumption below 25 grams per day.
However, since most people still eat processed foods, it would be wise for most people to limit their fructose to 15 grams or less.
This includes fruits, which also need to be carefully measured to make certain that you’re not inadvertently consuming too much fructose. See the table below to get an idea of how much fructose is in your favorite fruits.
Fruit Serving Size Grams of Fructose
Limes 1 medium 0
Lemons 1 medium 0.6
Cranberries 1 cup 0.7
Passion fruit 1 medium 0.9
Prune 1 medium 1.2
Apricot 1 medium 1.3
Guava 2 medium 2.2
Date (Deglet Noor style) 1 medium 2.6
Cantaloupe 1/8 of med. melon 2.8
Raspberries 1 cup 3.0
Clementine 1 medium 3.4
Kiwifruit 1 medium 3.4
Blackberries 1 cup 3.5
Star fruit 1 medium 3.6
Cherries, sweet 10 3.8
Strawberries 1 cup 3.8
Cherries, sour 1 cup 4.0
Pineapple 1 slice
(3.5" x .75") 4.0
Grapefruit, pink or red 1/2 medium 4.3
Fruit Serving Size Grams of Fructose
Boysenberries 1 cup 4.6
Tangerine/mandarin orange 1 medium 4.8
Nectarine 1 medium 5.4
Peach 1 medium 5.9
Orange (navel) 1 medium 6.1
Papaya 1/2 medium 6.3
Honeydew 1/8 of med. melon 6.7
Banana 1 medium 7.1
Blueberries 1 cup 7.4
Date (Medjool) 1 medium 7.7
Apple (composite) 1 medium 9.5
Persimmon 1 medium 10.6
Watermelon 1/16 med. melon 11.3
Pear 1 medium 11.8
Raisins 1/4 cup 12.3
Grapes, seedless (green or red) 1 cup 12.4
Mango 1/2 medium 16.2
Apricots, dried 1 cup 16.4
Figs, dried 1 cup 23.0
Clearly, eliminating excess fructose from your diet is far safer and more effective than taking a drug like Avandia if you have diabetes. Unfortunately, most doctors will not tell you this, because they too have been brainwashed by drug- and food industry propaganda.
YOU CAN CURE DIABETES
As I said earlier, type 2 diabetes is virtually 100 percent avoidable and can be effectively treated without medications in about the same percentage of cases by recovering your leptin and insulin sensitivity.
Leptin, a relatively recently discovered hormone produced by fat, tells your body and brain how much energy it has, whether it needs more (saying "be hungry"), whether it should get rid of some (and stop being hungry) and importantly what to do with the energy it has (reproduce, upregulate cellular repair, or not).
In fact, the two most important organs that may determine whether you become (type 2, insulin resistant) diabetic or not are your liver and your brain, and it is their ability to listen to leptin that will determine this.
And guess what...
The only known way to reestablish proper leptin and insulin signaling is through a proper diet and exercise!
There is NO drug that can accomplish this, but following the lifestyle strategies listed below can help you do at least three things that are essential for successfully treating diabetes:
1. Recover your insulin/leptin sensitivity
2. Help normalize your weight, and
3. Naturally normalize your blood pressure
None of these will drastically raise your risk of a heart attack the way Avandia will. Rather, they will benefit your heart and your entire body:
* Severely limit or eliminate sugar and grains in your diet, especially fructose, which is far more detrimental than any other type of sugar.
Finding out your nutritional type will help you do this without much fuss. While nearly all type 2 diabetics need to swap out their grains for other foods, some people will benefit from using protein for the substitution, while others will benefit from using more vegetable-only carbohydrates.
Therefore, along with reducing grains and sugars, determining your nutritional type will give you some insight into what foods you should use to replace the grains and sugars.
* Exercise regularly -- a must for anyone with diabetes or pre-diabetes. Typically, you'll need large amounts of exercise, until you get your blood sugar levels under control. You may need up to an hour or two a day. Naturally, you'll want to gradually work your way up to that amount, based on your current level of fitness.
* Avoid trans fats
* Get plenty of omega-3 fats from a high quality, animal-based source.
* Get enough high-quality sleep every night.
* Optimize your vitamin D levels. Recent studies have revealed that getting enough vitamin D can have a powerful effect on normalizing your blood pressure and that low vitamin D levels may increase your risk of heart disease.
Optimizing your vitamin D levels may also eliminate the risk of type 1 diabetes in your children if you are pregnant. It's also vital for infants to receive the appropriate amounts of vitamin D in their early years for these same reasons.
Ideally, you'll want to do this by exposing a large amount of your skin to appropriate amounts of sunshine (or a safe tanning bed) on a regular basis, year-round. Your body can safely create up to 20,000 units of vitamin D a day this way.
However, if neither of these options are available, you may want to use an oral vitamin D3 supplement. But remember, if you choose to take an oral supplement it's essential that you get your levels tested regularly by a proficient lab to make sure you're not reaching toxic levels, and are within the therapeutic range. Maintaining your vitamin D levels around 60-80 ng/ml can significantly help control your blood sugar.
* Address any underlying emotional issues and/or stress. Non-invasive tools like the Emotional Freedom Technique (EFT) can be extremely helpful and effective.
* Monitor your fasting insulin level. This is every bit as important as your fasting blood sugar. You'll want your fasting insulin level to be between 2 to 4. The higher your level, the worse your insulin receptor sensitivity is.
These are the top steps you should take, starting today, if you have type 2 diabetes. Doing so will virtually guarantee that your diabetes will disappear. And if you want to make sure you are not one of the millions impacted by the coming diabetes epidemic, these same steps will help you to stay healthy and diabetes-free.
ORIGINALLY PUBLISHED
http://articles.mercola.com/sites/articles/archive/2010/10/11/fda-curbs-avandia-diabetes-drug-use.aspx
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