Instead of publishing the results, the company spent the next 11 years trying to cover them up. The company did not submit the results to federal drug regulators, as is required by law.
The New York Times reports:
"The heart risks from Avandia first became public in May 2007 ... But the latest documents demonstrate that the company had data hinting at Avandia's extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public."
This drug is a classic example of most of what is wrong with the conventional medical paradigm.
Diabetes is an epidemic in the US as it currently affects nearly one in every four people in some form. Drug companies decided to produce a pill that in no way, shape or form treats the cause of the problem.
The ONLY thing this drug does is to help lower blood glucose, which has virtually no influence on the long-term damage due to type 2 diabetes. Nearly all of the pathology is caused by elevated insulin levels, and an optimal diet and exercise program can not only remedy that but virtually cure diabetes in 100% of people who are compliant with such a program.
But the drug does have two other major effects:
- Makes boatloads of money for the drug company
- Massively increases risk of heart disease and kills hundreds if not thousands who take it
To complete the story on why this is such a great example of what is wrong with the system, the manufacturer had massive conflict of interest and spent 11 years hiding information that they knew about the drug's dangers as it would adversely affect their sales.
Sadly, this is not front-page news and is buried so virtually no one hears of it. But you can bet your bottom dollar that if this were a vitamin, mineral or herbal supplement that caused a FRACTION of a FRACTION of the damage or had a similar history of corporate ethical breeches it would be front page news on virtually every media.
Avandia -- the Dangerous Diabetes Drug that Should NEVER Have Been Approved
Avandia hit the market in 1999 and following a multimillion-dollar advertising campaign it quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion.
Sales plummeted to $1.2 billion in 2009, two years after a study was published in the New England Journal of Medicine (NEJM) that linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death compared to patients treated with other methods.
There were many articles and reviews published about Avandia following the New England Journal of Medicine study, but research from the Mayo Clinic revealed that 90 percent of scientists who wrote favorable articles about the drug had financial ties to Glaxo.
Unfortunately, a committee of independent experts still recommended that Avandia remain on the market, despite its risks, and an FDA oversight board voted 8 to 7 to accept the advice.
Now Avandia is making headlines once again, this time because it has come out that the drug's maker went to great lengths to hide their deadly study results from the public eye.
Drug Maker Hid Avandia Heart Risks from Public, FDA
In 1999, drug maker SmithKline Beecham began a study to compare Avandia with another diabetes drug, Actos. The results showed that Avandia worked no better than Actos and had greater risks to the heart.
The study results were buried at the request of SmithKline executives and were not reported to federal regulators, as is typically required by law.
In documents uncovered by the New York Times, the company stated they could lose $600 million from 2002 to 2004 if Avandia's heart risks were made public. The New York Times also obtained a sealed deposition that included testimony from Dr. Rosemary Johann-Liang, a former supervisor in the FDA's drug safety office who "left the FDA after she was disciplined for recommending that Avandia's heart warnings be strengthened."
GlaxoSmithKline not only hid negative study data, they also manipulated study data to fit their agenda.
"An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called "Record," found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial's tally of adverse events, mistakes that further obscured Avandia's heart risks."
FDA Still Torn on Whether to Leave Avandia on the Market -- Despite Advice of Expert Panel
Shockingly, the FDA has left this drug on the market providing you with another powerful demonstration that the government does NOT protect you but partners with big business to protect their profits.
Hundreds of thousands of diabetics take Avandia every year, despite the fact that a two-year long Senate investigation released earlier this year found Avandia causes about 500 more heart attacks and 300 more cases of heart failure than Actos (Actos may also damage your heart -- just "not as much").
Earlier this month, a federal medical advisory panel even recommended that Avandia either be withdrawn from the market or have sales severely restricted due to its increased heart risks.
The FDA also put the so-called TIDE trial – which was ordered by the FDA in 2007 to compare Avandia with Actos – on hold until they review the panel's advice. While those already enrolled in the study can continue on, fortunately no one else will be able to sign up for the dangerous study – at least for now.
As FDA official Dr. David Graham said, given the known risks of Avandia, the study should be stopped immediately because it offers no benefit to participants and basically amounts to "human exploitation."
Even so, the FDA is still considering its regulatory actions and has made no final determination either way.
Unfortunately, the FDA has known about Avandia's dangers for years and ignored the concerns of their own experts before. The warning signs go back several years:
- GSK completed a study in 2003 in which diabetics given Avandia suffered far more heart problems than those given a placebo.
- Two months later, the World Health Organization alerted GSK that they'd also found a link between Avandia and heart ailments.
- In a June 2004 company meeting, GSK's Global Safety Board advised they needed to review all of Avandia's clinical trials to check for more indications of heart problems caused by the drug. As a result, GSK completed two reviews of their own data. In both cases they discovered that Avandia increased the risks of serious heart problems by nearly one-third, which is very significant since two-thirds of diabetics die of heart problems!
In addition, according to an analysis done by the Institute for Safe Medication Practice, in the third quarter of 2009 Avandia ranked number one among ALL prescribed drugs in the number of serious, disabling and fatal problems!
Drugs Cannot Treat the Underlying Cause of Diabetes!
If you or someone you know is diabetic and taking medication for it, please understand that you cannot successfully treat the underlying cause of diabetes with drugs.
Avandia works by making diabetes patients more sensitive to their own insulin, helping to control blood sugar levels. In fact, most conventional treatments for type 2 diabetes utilize drugs that either raise insulin or lower blood sugar. Avandia, for example, lowers your blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin.
But you must understand that diabetes is NOT a blood sugar disease like your doctor may have led you to believe.
Type 2 diabetes is actually a disease caused by insulin resistance and faulty leptin signaling, both of which are regulated through your diet.
Conventional treatment, which is focused on fixing the symptom of elevated blood sugar rather than addressing the underlying disease, is doomed to fail in most cases.
Virtually 100% of Type 2 Diabetics Can be Cured if They are Compliant with Lifestyle Changes
Type 2 diabetes is virtually 100 percent avoidable, and can be effectively treated without medications in about the same percentage of cases.
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.
How is this done?
Well, that's the kicker. 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 these simple guidelines can help you do at least three things that are essential for successfully treating diabetes: recover your insulin/leptin sensitivity, help normalize your weight, and naturally normalize your blood pressure.
As an aside, none of these will drastically raise your risk of a heart attack the way Avandia will … and in fact will have only positive benefits on 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.
- 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.
The recommendations above are the key steps you need to achieve this reduction.
So please remember that a drug will never treat the underlying cause of type 2 diabetes the way these lifestyle changes will.
It looks like Avandia is set to go the way of Vioxx, which was also pulled from the market after killing 60,000 people. You don't need to wait for the red tape to be removed to start looking out for your own health.
Diabetes runs in my family. About 15 years ago, I diagnosed my father with it and gave him these same guidelines to follow. He's 81 years old and does two hours of exercise every single morning. He's been able to keep his diabetes under control without taking a single drug by following these principles … and you can too.