By Dr. Mercola
Drugmaker GlaxoSmithKline has preliminarily agreed to a $3 billion settlement over the sales and marketing practices of several of its drugs, including the diabetes drug Avandia.
This represents the largest federal drug-company settlement to date, surpassing the $2.3 billion paid by Pfizer in 2009 for illegally promoting off-label uses of four of its drugs.
The sum, though extraordinarily large by most people's standards, represents only a slap on the wrist to the drug giant, which assured investors the payments would be funded by "existing cash resources." To put things into perspective, GlaxoSmithKline has a market value of more than $110 billion, according to the New York Times.
This massive financial clout essentially allows them to engage in criminal behavior that they can later buy their way out of – not unlike the way you might pay for a speeding ticket. As Sidney M. Wolfe, director of Public Citizen's health research group, told the Washington Post:
"The size of the penalties, although large, are not as large as the money [the drug companies] make and so they keep doing it over again … The only way this is going to stop, or get reversed, is to greatly increase the size of the penalties or to start sending some of the executives to jail, if appropriate."
The Culmination of a Seven-Year Investigation
GlaxoSmithKline's $3-billion settlement is intended to bring a nearly decade-long legal saga to a close. It started in 2004, when federal prosecutors began investigating the drug maker for marketing a handful of its drugs for unapproved uses, as well as the suspect techniques their reps used to influence doctors.
The settlement also includes a U.S. Justice Department probe into potential Medicaid reimbursement fraud, as well as an investigation into the company's development and marketing of the Avandia diabetes drug.
After hitting the market in 1999, a 2007 study in the New England Journal of Medicine 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 GlaxoSmithKline.
Unfortunately, a committee of independent experts still recommended that Avandia remain on the market, despite its many risks, and a U.S. Food and Drug Administration (FDA) oversight board voted 8 to 7 to accept the advice.
Avandia works by making diabetic patients more sensitive to their own insulin, resulting in lower blood sugar levels. The problem is that despite clinically measurable improvement in blood sugar control following the use of this drug, hard outcomes associated with diabetes such as endothelial dysfunction and heart attack risk may actually worsen.
Why? Because Avandia, like all pharmaceutical drugs, are synthetic chemicals and do not obey the same laws that natural substances do in your body (Remember: our body is composed of the natural things we have eaten and not chemicals).
A simple change in the geometry of a molecule's "handedness" – i.e. whether it turns a beam of polarized light to the "left hand" or "right hand" -- can make the difference between endocrine correction and disruption; therapeutic activity and toxicity.
Although Avandia may correct a blood sugar imbalance by locking into the insulin receptors in a superficially beneficial way, it may also block out and/or disrupt many other processes in the body that can result in great harm.
Nature actually does the job much better anyway. In a 2009 study published in the Journal of Phytomedicine the herb and traditional food known as Bitter Melon was found to be superior to Avandia in the management of diabetes and its related complications.
It is also important to remember that type 2 diabetes is not caused by a lack of any drug, and that nutrition and lifestyle changes, as well as regular exercise holds the key to improving the health and well being of diabetics in a sustainable manner.
Despite the availability of alternative approaches, millions of people have been told to take Avandia and have been exposed to these unacceptably high-risk side effects. The statistics show that more than 80,000 diabetics have suffered from strokes, heart failure or other complications including lethal heart attacks from this dangerous drug.
It took nearly 10 years of the drug being on the market for the FDA to finally take action and restrict access to this dangerous drug, whereas the European Medicines Agency banned it altogether.
GlaxoSmithKline Covered up Negative Trial Data for 11 Years
As it turns out, GlaxoSmithKline spent 11 years covering up trial data that showed Avandia was a risky drug for the heart. In 1999, drugmaker 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 GlaxoSmithKline 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. According to the Times:
"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."
Incidentally, a two-year long Senate investigation released in 2010 also 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").
Drug Companies are the Thugs of the Medical World
No less than 19 drug companies made AllBusiness.com's Top 100 Corporate Criminals List for the 1990s -- which is par for the course when it comes to the drug giants. Fraud, bribery, illegal kick-backs and criminal activity are not at all unusual, and the fines and legal fees they eventually end up paying for their "get out of jail free card" are widely regarded as merely the cost of doing business.
Once you've been exposed to the seedy underbelly of the drug business—the LEGAL drug business—you can't but realize that we're dealing with a very large group of criminals and felons -- the thugs of the medical world. There's really no nicer way to put it.
What will really get your blood boiling, however, is how easily these companies are able to manipulate the system and get off scot-free for crimes that "ordinary" Americans would be sentenced to life in prison for committing.
For instance, Pfizer, which was found guilty of fraud many times over in 2009, should have been banned from dealing with Medicare and Medicaid again, as is automatically required for any company found guilty of fraudulent activity. But Pfizer is still doing business with these government programs because federal prosecutors allowed the drug giant to avoid being sentenced for massive fraud and deception by letting them form a sham company to take the fall.
So, in the end, Pfizer's "imaginary friend" Pharmacia & Upjohn shouldered the conviction, even though it had never sold any drugs. As CNN found, "the subsidiary is nothing more than a shell company whose only function is to plead guilty."
GlaxoSmithKline Whistleblower Reveals Company Knowingly Put Patients' Lives at Risk
In a 60 Minutes interview, whistleblower Cheryl Eckard reveals the gross negligence that occurred at the Cidra pharmaceutical plant, which is run by one of GlaxoSmithKline's subsidiaries. Eckard's quality assurance team uncovered numerous production problems, including failures on production lines that led to inconsistent dosages and employees contaminating products by not following procedures.
Worse yet, potent and potentially dangerous drugs were literally ending up in the wrong bottles! The antidepressant Paxil was mixed into bottles of Avandia. And Avandia was found in packages of the over-the-counter antacid Tagamet. All in all, Eckard identified nine different mix-ups of various drugs.
She urged the vice president of quality assurance for North America to stop the trucks from leaving the dock the day she discovered the mix-ups, and to shut down the factory and contact the FDA. But nothing happened… And, when one such mix-up was later discovered by a patient, GSK denied it ever happened. But "we all knew, they all knew it was real," said Eckard.
Finally, after eight months of reporting problems at the plant, Eckard sent a summary to seven executives detailing the numerous quality problems, warning that if the FDA knew of these issues, the plant would likely be seized.
Just weeks later, Eckard was out of a job. Concerned for the welfare of patients taking the affected drugs, she blew the whistle and notified the FDA. Federal agents searched the plant and seized hundreds of millions of dollars' worth of defective drugs. In the end, GlaxoSmithKline pleaded guilty to a felony: knowingly manufacturing and selling adulterated drugs, manufactured between 2001 and 2005.
But incredulously, their punishment amounted to only $150 million in criminal fines and $600 million in civil penalties -- not one single person in charge of the debacle went to jail!
Likewise with the current settlement, none of the actual people involved in this fraud and criminal activity -- which has taken the lives of innocent people -- are being held accountable. Companies can simply set aside billions of dollars to "deal with" their "legal issues" and continue on with their felonious behavior completely unfazed.
Of course, it certainly doesn't hurt that drug companies run the BIGGEST political lobby, and political lobbying is one of the primary reasons why the drug companies are controlling nearly the entire health industry, as well as many facets of the U.S. government. In the CBS News video below, crooked lobbyist Jack Abramoff explains how he influenced Congress for years, and how this kind of corruption still continues.
Drug Companies Cannot be Trusted: How to Take Control of Your Health
One thing should be crystal clear at this point: the drug industry simply cannot be trusted. And they have the criminal history to prove it. Drug companies have accumulated so much wealth, power and government influence that they have been able to profit from permanently disabling, crippling and even killing their consumers, without suffering any serious consequences to themselves.
Unfortunately, the people who stand to lose in this equation are you, your family and millions of others who use drug company products without realizing that oftentimes those products have been found to cause far more harm than good.. But there is an alternative, and that is to take control of your health.
Many diseases of modern society -- heart disease, type 2 diabetes, high blood pressure, obesity – can be prevented or cured using lifestyle changes. We'll never know how many people's lives could have been saved if those taking GlaxoSmithKline's Avandia had opted for diet and exercise changes instead -- but what we can do is try to prevent this scenario from happening again in the future by not falling prey to the next blockbuster drug to hit the market. In the case of type 2 diabetes, the following steps will work well to manage and reverse the condition in many. Plus, these tips can be applied by anyone seeking to live a healthier life, naturally, whether you have diabetes or not.
- Ideally eliminate grains and sugar entirely from your diet, especially fructose, which is far more detrimental than any other type of sugar. This is extremely important! Drinking just one sweetened drink a day can raise your diabetes risk by 25 percent compared to drinking one sugary drink per month, so you really need to evaluate your diet and look for hidden sources of sugar and fructose. Artificially sweetened food and drinks should be avoided as well.
This also means avoiding most processed foods, as they are loaded with fructose. You may even need to avoid fruits (especially pasteurized fruit juices) until your diabetes is under control.
Following my nutrition plan will help you do this without much fuss. It’s important to realize that nearly all type 2 diabetics need to swap out their grains for other foods, such as healthy sources of protein or vegetable-only carbohydrates. It would also be wise to avoid white potatoes and all legumes (beans).
- Exercise is an absolutely essential factor, without which you're highly unlikely to get this devastating disease under control. It is clearly one of the most potent ways to lower your insulin and leptin resistance. Make sure to incorporate high-intensity Peak Fitness exercises. These types of exercises boost fat loss, promote muscle building, and help your body produce human growth hormone (HGH) naturally. Typically, you'll need to exercise regularly and with some intensity until you get your blood sugar levels under control.
- Avoid trans fats as they will profoundly worsen insulin resistance.
- Consume natural saturated fats, such as grass-fed organic meat, raw dairy products, avocados, and coconut oil. These saturated fats provide a concentrated source of energy along with the building blocks for cell membranes and a variety of hormones and hormone-like substances. When you eat healthy fats as part of your meal, they slow down absorption so that you can go longer without feeling hungry. In addition, they act as carriers for important fat-soluble vitamins A, D, E and K.
There are more than a dozen different types of saturated fat, but you predominantly consume only three: stearic acid, palmitic acid and lauric acid. It’s already been well established that stearic acid (found in cocoa and animal fat) has no effect on your cholesterol levels at all, and actually gets converted in your liver into the monounsaturated fat called oleic acid. It also has potential anti-cancer properties.
The other two, palmitic and lauric acid, do raise total cholesterol. However, since they raise “good” cholesterol as much or more than “bad” cholesterol, by consuming them you’re still lowering your risk of heart disease.
- Get plenty of omega-3 fats from a high quality, animal-based source such as krill oil. And consider incorporating other nutrients, spices and supplements with proven value for type 2 diabetes, such as l-arginine, cinnamon and stevia.
- 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 mentioned above are the key steps you need to achieve this reduction.
- Get enough high-quality sleep every night.
- Optimize your vitamin D levels. Maintaining your vitamin D levels around 60-80 ng/ml can significantly help control your blood sugar. In addition, recent studies have revealed that getting enough vitamin D can also have a powerful effect on normalizing your blood pressure, and reduces your risk of heart disease.
Attaining optimal vitamin D levels can also prevent 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 the 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. As a last resort, a vitamin D3 supplement can be used, and new research suggests most adults need 8,000 IU a day to keep their levels optimized. Just remember to get your levels tested regularly by a proficient lab to make sure you're staying within the therapeutic range.
- Address any underlying emotional issues and/or stress. Non-invasive tools like prayer, journaling and meditation can be extremely helpful and effective.