AVANDIA FALLS - DID FDA INTENTIONALLY PUT PATIENTS AT RISK?
Byron J. Richards, CCN
September 25, 2010
In the face of overwhelming evidence that the diabetes drug Avandia causes heart attacks, the lead-footed FDA finally removed the dangerous drug from most of the U.S. market while European health officials totally removed it from the market. By leaving it on the market as a diabetes drug of last resort in the U.S. the FDA was seeking to throw GlaxoSmithKline a dog bone for their future legal liability cases. Escaping public attention is that fact that the last FDA management team was criminally negligent in allowing Avandia on the market without a black box warning.
The record shows that the FDA knew full well the drug caused heart attacks before it was ever put on the market. On June 6, 2007 the New York Times revealed a stunning event that occurred in March of 2006 wherein FDA safety supervisor Dr. Rosemary Johann-Liang approved a black box warning on Avandia to warn about the risk for congestive heart failure. Former FDA commissioner, Andrew von Eschenbach and his management team ordered her to retract her approval of the warning. She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia.
The FDA said nothing as the sales of Avandia skyrocketed to 3.2 billion. It was only after the private sector started publishing emerging risk data that Congress became alarmed and scheduled FDA executives for a hearing. Only at that time did the FDA begin to move and take damage control steps. Not damage control for public safety, but damage control for their own rear ends. So the drug stayed on the market for three more years, weakening the legal liability case against GlaxoSmithKline, giving Andrew von Eschenbach time to get out of Dodge, and killing numerous Americans.
In a normal world this is called manslaughter. In the world of Big Pharma and the FDA this is business as usual. Until criminally negligent Big Pharma executives are put behind bars, and when appropriate the co-conspiring FDA management, then U.S. citizens will be seriously injured and U.S. taxpayers will foot Big Pharma’s legal defense with increased costs for drugs.
Underneath the problem is the simple fact that nutrition works far better than drugs for the long-term management of just about any issue relating to preventive and metabolic health.
Avandia is in a class of drugs called a thiazolidinediones. Its competitor, Actos, remains on the market. Both Avandia and Actos will break your bones. Actos can still cause heart attacks, just not as blatantly as Avandia. In comparison, the fish oil nutrient DHA will help preserve your bones and rejuvenate your heart’s function. Avandia, Actos, and DHA all activate PPAR gamma. Understanding why the drugs are so dangerous and why the nutrient is so helpful is a prime example of why nutrition excels at restoring damaged metabolism and drugs are a fast track to a number-manipulating nowhere.
PPAR stands for peroxisome proliferator-activated receptors. There are a number of different types of PPARs. When a PPAR is activated within one of your cells, it binds onto a specific region of DNA and tells it what to do (a transcription factor that in turn activates messenger RNA). PPARs are found in many places, especially within your fat, circulation, and key organs of circulation such as your muscles, heart, liver, and kidneys—they are powerful regulators of metabolism.
Avandia and Actos are not part of human evolution. They are potent gene-regulating drugs. They are given to diabetic patients to improve insulin resistance, lower triglycerides, and boost HDL cholesterol—all of which they can do. But at what price? They stress out your liver, kidneys, bones, and heart. If you keep over-eating while taking them, you will simply gain more weight and stress your heart even more. They provoke fluid retention, swollen legs, muscle aches, and infection. DHA has all of the benefits and none of the risks.
PPAR gamma induces new fat cells to form. While that may not sound like something you want, it actually is (unless you are stimulating too many new fat cells and overeating at the same time). New fat cells are metabolically more fit and they make more adiponectin, which lowers insulin resistance and is actually highly protective to your circulatory system. In a nutshell, this is the problem of drugs—they force the function of powerful genes in a way that is no longer under natural regulation. It’s like taking a sledgehammer to a gene-regulating system that should be handled like an elegant ballet. This is what drugs do. Nutrition does not work this way.
Elevating triglycerides (fat blobs) in your blood jams the highways of your circulation with slow-moving sludge, induces leptin resistance and weight gain, and is a key indicator of future cardiovascular trouble. New research shows that a powerful protein in your circulation (GPIHBP1) activates the triglyceride-clearing enzyme called lipoprotein lipase. Without activation of GPIHBP1 triglycerides pile up in your blood and you are in deep health trouble. GPIHBP1 is turned on by PPAR gamma.
This is a rather sad commentary on food-addicted, over-eating Americans. Forcing GPIHBP1 on with a drug while you keep eating too much is not going to be helpful. First of all, for every fat blob you break down your body will attempt to make another in order to store excess calories as a natural defense against being poisoned by excess food. If a person takes a high dose of these drugs, forcing their body not to make triglycerides, then extra sugar will permeate tissues and start cementing body tissues (glycation) and damaging the heart, kidneys, and eyes.
Drugs like Avandia and Actos were approved by the FDA because they can change numbers, they were never proven to fix the health of a type 2 diabetic. Unfortunately for those taking them, they also change gene function in undesirable ways. Your heart wants to burn fatty acids as its primary fuel. When PPAR gamma receptors are excessively activated within your heart—which happens with drugs—then it forces your heart to accumulate fat and burn sugar instead. This leads to heart enlargement and then heart failure. How can any doctor in his or her right mind justify such a risk?
Ironically, diabetes patients given these drugs are already at increased risk for heart failure.
PPAR gamma and GPIHBP1 are naturally activated when you eat less food. It is blunted when you overeat. If you are overweight and engage the process of weight loss then you are naturally managing this gene system to be healthier. If you take DHA at the same time you not only help your metabolism work better, you actually protect your heart and help strengthen it. Why? Because nutrients do not force gene activation. DHA activates multiple genes including those that help your heart work better. DHA is a vital nutrient of human evolution. Your body knows how to use it and if it isn’t in your diet you are in significant health trouble, as your natural gene-regulating system is handicapped.
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I’m just trying to illustrate a simple and powerful health point. Natural strategies work in tandem with your body to promote healthy function. Drugs change numbers and far more often than not actually damage your health. Don’t look to Western medicine for the prevention of anything or for the long-term recovery related to your metabolic or cardiovascular health.
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