On February 28, 2012, the FDA added two new WARNINGS to the already dangerous list of side effects for Statins. The list already includes muscle pain, Rhabdomyolysis, kidney failure, liver failure and death. The new WARNINGS are necessary because mounting evidence shows that Statins also cause a significant increase in the risk of diabetes and cognitive decline, including memory loss.
Statins are among the most advertised and the most used drugs in the world. They are also the most profitable. Lipitor, which became available late last year in generic form as atorvastatin, is the world’s all-time biggest selling prescription medicine with cumulative sales of over $130 billion. Other prominent statin drugs include AstraZeneca’s Crestor and Merck & Co’s Zocor.
The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial showed a 27% increase in diabetes mellitus in patients taking rosuvastatin compared to placebo. Also, the Pravastatin or Atorvastatin Evaluation and Infection Therapy: Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy showed that high-dose atorvastatin can worsen glycemic control.
If the FDA was doing its job these drugs, which have been around for twenty years would have been pulled off the market long ago. However, the FDA’s response was to protect the drug companies interests over the public. The FDA statements downplay the dangers and states that the new information should not scare people into stopping taking the drugs because Statins have been shown to significantly reduce the risk of heart attack and heart disease. Of course that makes sense, right? Heart attacks can sneak up on you without warning, but diabetic gangrene is just a subtle, gradual color change. Frankly, I would rather not have either one.
“The value of statins in preventing heart disease has been clearly established,” said Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”
Oh, so as long as you know you’ve got a 27% chance of eventually getting diabetes and losing your leg to gangreen from taking Statins it’s alright.
The FDA said it was aware of studies in which some patients taking Statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes, but they ignored them until now.
Apparently, the FDA finally felt compelled to act now because of additional new studies that show that the Statin drugs also cause significant cognitive side-effects such as memory loss and confusion. However, they were quick to point out that the reports of these findings generally have not been serious and the symptoms were reversed by stopping use of the Statin. But didn’t they say this shouldn’t scare people into not taking them?
In another amazing attempt to make a negative sound positive, the FDA says it is also eliminating the recommendation that patients on Statins undergo routine periodic monitoring of liver enzymes, because, according to the Agency, the “FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect.”
What this really means is that even though they know that the Statin drugs cause fatal liver disease, it is so unpredictable and happens so rapidly once it starts that periodic testing cannot detect it early enough to do any good.
Last June, 2011, the FDA finally admitted after 20 years of watching Statins cause Rhabdomyolysis that ic can indeed damage muscles as well as the kidneys and lead to kidney failure and death. Apparently, the data became too obvious to be ignored, so what do they do, they report the data, but minimize the harm done by downplaying the numbers of people that are at risk.
In the past, the FDA used to recall and ban every drug that killed people. Now, however, they arrogantly announce that a few deaths are worth the benefits of the drug, but never tell you just how many deaths are occurring. Instead they play a game with the numbers. They merely state something like the following: “hospitalized rhabdomyolysis occurs in 4.9 people out of every 100,000 people exposed to simvastatin (Zocor) for one full year.” (FDA Drug Safety Communication; June 8, 2010)
The truth is that there were 94.3 million prescriptions for Simvastatin filled in 2010. Based on the 4.9 cases of hospitalized Rhabdomyolysis per 100,000 prescriptions, that means that 4900 people were hospitalized in 2010 and many of them died. The FDA does not want to publish data on how many died. However, if you or a loved one were among those killed by these drugs, you would consider that number extremely significant. Investigators have found that at least 12% of Rhabdomyolysis cases die from the disease, which indicates that at least 588 people died from side-effects caused just by Simvastatin in 2010 alone.
What do I recommend? I routinely take my patients off all Statin drugs and prescribe the natural supplement Red Yeast Rice Extract that the drug companies copied to make the Statin drugs in the first place.
Red Yeast Rice is a preparation made from a yeast that is commercially grown on rice grains. The Rice and yeast, which is deep red in color, are ground up into a red powder. Red Yeast Rice Extract contains substances that work together to inhibit the activity of the enzyme necessary for production of cholesterol in the body.
For hundreds of years, the Chinese have used it as a spice, as a food preservative, and to make rice wine. In recent years, Red Yeast Rice Extract has been investigated as an agent for lowering cholesterol and triglycerides. According to one double-blind, placebo controlled clinical trial conducted by the National Medical Association Scientific Assembly, serum total cholesterol dropped 25.9% LDL cholesterol dropped 32.8% and triglycerides were reduced by 19.9% after only eight weeks.[1]
In another clinical trial, 324 patients with hyperlipidemia were administered Monascus purpureus (red yeast) extract for eight weeks. At the end of eight weeks of treatment, the red yeast extract raised high density lipoprotein cholesterol (HDL cholesterol or “good” cholesterol) by 19.6%. The results of the trial indicate the red yeast extract is an “effective and safe preparation in the treatment of hyperlipidemia.”[2]
There are at least nine naturally occurring compounds in red yeast that are chemically related to statins, the widely prescribed pharmaceuticals used for their cholesterol-reducing effects. Red yeast extract has HMG-CoA (menvinolin) reductase inhibitors. These inhibitors may block the enzyme responsible for making cholesterol in the body.
When this synthesis is blocked, the body simply produces less LDL cholesterol, measurably reducing its presence in the blood. In addition, red yeast raises HDL cholesterol to more desired levels. Increases in HDL levels boost cardiovascular health since HDL cholesterol helps eliminate LDL cholesterol from the bloodstream.
Note: It is not known if red yeast extract inhibits the body’s production of CoEnzyme Q10 (as statin drugs do). Therefore, Dr. Hansen recommends supplementation with a minimum of 50 mg of CoQ10MAX twice daily while taking Red Yeast Rice Extract.
R e f e r e n c e s
1. A monascus Purpureus rice preparation reduces serum cholesterol and triacylglycerols in elderly with primaryhyperlipidemia: A randomized double blind clinical trial. National Medical Association Scientific Assembly. August1-6, 1998.
2. Clinical trial of extract of Monascus purpereus in the treatment of hyperlipidemia. Chinese Journal ofExperimental Therapeutics for Prepared Chinese Medicine. 1995, 1(1):1-5C