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A Bombshell Drops on Cholesterol Medication's Glass House
November 19, 2006
It had to happen sooner or later. On October 3, 2006, after extensive review of all studies relating to cholesterol-lowering benefits by statin drugs, scientists reporting in the Annals of Internal Medicine pulled the rug out from under the current government-sanctioned cholesterol levels for reducing cardiovascular disease. Their conclusion, “current clinical evidence does not demonstrate that titrating lipid therapy to achieve proposed low LDL cholesterol levels is beneficial or safe.”
This is not a trivial issue. Many billions of taxpayer dollars have been wasted on the cholesterol drug scam. The health and well being of millions of Americans may have been compromised by reckless lowering of cholesterol, a substance that is vital to health and energy production.
It has long been recognized that adults who have naturally lower cholesterol levels during their 40s and 50s have less heart disease as they grow older. A large body of science supports the notion that LDL cholesterol levels lower than 130 mg/dL is an excellent goal for one and all. How a person should arrive at this goal is a matter of considerable debate. A good diet and exercise is the foundation for any person's health program and for many this approach is adequate.
The use of nutritional supplements to help lower cholesterol, products that have virtually no side effects and may be highly effective, is considered by the FDA to be an illegal health claim. Instead, the FDA expects Americans to use statin drugs to accomplish this goal, even though the medications have a general anti-energy effect and long list of potentially serious side effects that are not clearly explained to those taking the medications or even to the doctors giving them out.
To make matters worse, several years ago the government-funded National Cholesterol Education Program promoted new guidelines for the use of these drugs. It was recommended that individuals at high cardiovascular disease risk attain LDL levels < 100 mg/dL and individuals at very high cardiovascular risk attain LDL levels < 70 mg/dL. These are abnormally low levels of cholesterol, meaning drugs must be used to create an artificially low level of LDL cholesterol, an unnatural physiological condition. This is very difficult to do and requires high doses of statins, doubling or tripling the dose, oftentimes combined in dangerous combinations with other drugs (like fibrates).
These therapies are extremely expensive and often do not work. These guidelines immediately boosted the sales of statins from fifteen billion per year when the report was released in 2004 to over twenty-two billion in 2005. And now we come to find out there is not a shred of scientific evidence to support that lowering cholesterol in this manner will reduce cardiovascular disease, compared to simply having an LDL lower than 130.
Statins are also being pushed for prevention of a first heart attack in people with only moderate cardiovascular risk. A careful analysis of the statistical data shows that such statin use may very slightly reduce cardiovascular death in this preventive population over a ten year period. However, the drugs kill 1% as a side effect, due to accidents, suicide, and infection, completely canceling out any benefit. This means there is no value at all, from a societal point of view, in wasting billions of dollars of taxpayer money on this pointless preventive strategy.
The amount of money spent on this fraudulent scheme is at least seven billion dollars a year, money that is in essence stolen from hard working Americans. Class-action lawsuits have already been filed against Pfizer for illegal Lipitor promotion, many are sure to follow.
The National Cholesterol Education Program is part of the National Heart, Lung, and Blood Institute (NHLBI), meaning that it is part of our federal government and has an operating budget of about one million dollars per year. In 2004 it selected a panel of nine “experts” to review statin drug use and make recommendations as to guidelines doctors should follow to reduce cardiovascular disease.
On July 13, 2004, these nine experts published their findings in Circulation, a journal of the American Heart Association. Their paper lists the National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association as coauthors – meaning these various groups supported the findings. It doesn't appear to be very difficult to get published in your own marketing magazine.
Circulation failed to disclose that six of the nine authors had direct financial ties to the makers of statin drugs. Those drugs include Pfizer's Lipitor; Bristol-Myers Squibb's Pravachol, Merck's Lovastatin, and AstraZeneca's Crestor. For example, Newsday.com reported on July 14, 2004, “Dr. H. Bryan Brewer, a physician-scientist at the National Heart, Lung and Blood Institute, was one of the guidelines' authors. He was the subject of a letter to the director of the National Institutes of Health last week from a consumer watchdog, Public Citizen's Health Research Group. The advocacy organization charged that Brewer had failed to disclose his ties to AstraZeneca. Brewer, according to the letter, had written a glowing report in a medical journal about Crestor without disclosing that he is a paid consultant and had presided over a company-sponsored symposium.”
Even though these connections were slightly exposed in the media at the time, no action was taken to review the credibility of the statin science by other less biased researchers. Instead, the public relations buzz was that the statin “science” was solid.
The October 3 review in the Annals of Internal Medicine tears this “solid science” to shreds, something that should have been done two years ago. The review explains the deceitful manipulation of statistics and how not one study proves that lowering LDL cholesterol to the super low levels recommended has any benefit in reducing cardiovascular disease. Simply put, this report is shocking.
The bottom line: there is no credible science, and there never was, that offered proof that lowering cholesterol levels to physiologically abnormal levels reduced cardiovascular risk. Thus, basing a broad governmental public health recommendation on no solid science is flat out wrong. Why aren't these faulty recommendations being reversed?
In my book, Fight for Your Health: Exposing the FDA's Betrayal of America, I spend several chapters documenting all the clearly known risks of statin drugs, citing over 140 references. Even though it is the most widely used drug in America, most doctors prescribing it are not aware of its many side effects or numerous interactions with other drugs. Statins are known to disrupt energy production, weaken the adrenal glands, interrupt vitamin D synthesis, block co-enzyme Q10 production, induce cardiomyopathy, damage kidneys, weaken or damage muscles, and in a variety of situations increase cancer risk.
There are numerous reports of suicide, depression, and cognitive impairment from statin use. Since many elderly patients are using statins, brain damage with ongoing use is likely. This is not difficult for anyone to understand. Brain cells contain higher levels of cholesterol in their cell membranes, enabling nerve cells to survive longer. Nerve cells do not split and divide like other cells in the body, thus they must have a higher level of cholesterol – this is normal. One clear adverse effect of statins is lowering the nerve cell-membrane level of cholesterol, resulting in premature cellular death. Maintaining proper levels of cholesterol in the brain is vital to normal nerve function. This toxic effect of statins will be worse on a higher dose and nerve damage will progressively accumulate over time. Doctors, mostly unaware they could be inducing cognitive decline or neuropathy in their patients, may prescribe other brain medications to treat the decline in nervous system function, thinking the symptoms are just part of the aging process. This is a tragedy.
Another seldom mentioned adverse side effect of statins is that they directly interfere with immune system function. Statin pushers like to claim this is a benefit, reducing inflammation. There is an element of truth in this; however, there are much better ways to reduce inflammation than by use of statins that actually block immune signals. The same system being blocked by statins is required for a robust response to combat infection. The immune suppressing effects are so powerful that statins are being considered as adjunctive therapy for organ transplant patients. What happens to a person's immune defense when they are on a super high dose of statins to lower cholesterol to abnormally low levels? How is anybody on high-dose statin therapy supposed to fight the flu? What happens if a pandemic flu strain hits? Guess which citizens won't make it.
A major part of the drug safety problem in the United States is that sleazy Big Pharma-sponsored studies are published as if they are science. Mainstream media forwards the Big Pharma sales pitch. This is done to blatantly promote the use of many dangerous drugs (like Vioxx), as well as to improperly discredit competition to drugs, i.e., the very safe nutritional supplements.
We hardly heard a peep from the mainstream media regarding these rather dramatic findings. The New York Times did manage to report on this issue; however, the reporting is more a defense of the status quo than a consumer wake-up call to a major health scam costing us billions of dollars.
Circulation is operated by the American Heart Association (AHA). All the big statin companies, Pfizer, Bristol-Myers Squibb, Merck, and AstraZeneca, pay big money to the AHA every year (so does Bayer for aspirin promotion). The AHA has a long history of taking in millions from statin-producing companies and other heart-drug producers, supporting questionable products in return. Once Big Pharma gets the slanted study published, the mainstream media is fed press releases and they promote the information to the unsuspecting public as if it is a major scientific discovery. Big Pharma pays several billion dollars a year for media advertising – you better believe the top media executives know where their bread is buttered.
During the time in 2004 that Big Pharma was plotting its statin bonanza it needed to fire cannonballs at its most widely recognized competition, Vitamin E and other antioxidants. No problem. First, in August 2004, they use their marketing magazine to print a bogus article, contradicting hundreds of nutritional studies, stating that antioxidants A, C, and E are not effective for cardiovascular disease risk reduction. Then, in November of 2004, with trumpets blaring at their yearly AHA meeting, they make the brazenly fraudulent claim that vitamin E increases the risk of death by 6%!!!
Outside the marketing meeting masquerading as a scientific conference, the chairman, Dr. Raymond Gibbons of the Mayo Clinic in Rochester, Minnesota, is holding a dog and pony show press conference. “I spend all my time trying to tell patients why they should not take vitamin E. Too often in terms of the supplements there's very scant science. In this area, we have the science. Vitamin E doesn't work.” He implored his captive audience of reporters to help him convince patients to stop taking Vitamin E and take the “proven” drugs. The next day, all major media ran the story telling consumers vitamin E was dangerous. Program effective. Damage done.
Within weeks the American Heart Association had brainwashed doctors and the American public to actually think vitamin E was dangerous, clearing out the primary competition to statins for the prevention and treatment of cardiovascular disease. Doctors were telling all their patients to stop taking vitamin E. The anti-vitamin rhetoric spread like wild fire through doctor's offices around the nation.
Within a week the bogus vitamin E information coming from the American Heart Association meeting was debunked. Physician and nutritional expert, Alan Gaby, pointed out all the flaws as well as the safe and effective track record of vitamin E. By April of 2006, the leading antioxidant scientists in the world had published a comprehensive review showing the safety of vitamin E up to doses of 1600 IU per day, again debunking the false vitamin E story and explain the high degree of safety of antioxidant nutrients. The media was nowhere to be found; the public never heard vitamin E was truly safe and vital for immune function, prevention of cognitive decline, and a wonderful nutrient for cardiovascular support.
In July of 2005, the Journal of the American Medical Association published the results of an amazing vitamin E and heart disease study. After tracking 40,000 women for eight years it was proven that vitamin E lowered the risk of cardiovascular death by 24%! However, JAMA authors, going along with the vitamin E smear campaign, concluded that vitamin E was not worth recommending! Any drug with that kind of statistical evidence would be a billion dollar blockbuster. The idiotic media failed to look at the study and reported everywhere that vitamin E was not needed, denying women the true information about a wonderful cardiovascular support nutrient.
It should not be surprising that the American Heart Association's bogus attack on vitamin E was rooted in their bogus science about the benefits of using statin drugs to lower LDL cholesterol to abnormally low physiological levels. The degree of collusion between the American Heart Association, Big Pharma, government agencies, scientific journals, and the media is simply appalling. The American Heart Association is now seen as the Big Pharma front group they truly are.
Where is the FDA when they are needed? Why isn't the FDA requiring more testing before allowing doctors to use statins in an unapproved manner? Why is the FDA attacking super-safe nutritional strategies to help Americans naturally and safely normalize cholesterol levels?
There is no short cut to healthy cholesterol function in the human body. Nutrition and exercise are the foundation. Many nutritional ingredients may be able to assist a person in their quest to improve their cholesterol levels. Despite this fact, the FDA is trying to trample the first amendment and prevent you from learning about these options; however, Americans do have choices.
There is good reason many Americans are turning to safe and effective natural options as part of a health strategy to maintain cholesterol levels in a better range. This latest fiasco with cholesterol medication is proof that government and Big Pharma work together to push drug sales, oftentimes disregarding the true effects on human health, including safety. I wonder if the American Heart Association will learn that those living in glass houses should not throw stones? How much longer can Americans tolerate a government, media, and health industry on the take from Big Pharma?
This is not a trivial issue. Many billions of taxpayer dollars have been wasted on the cholesterol drug scam. The health and well being of millions of Americans may have been compromised by reckless lowering of cholesterol, a substance that is vital to health and energy production.
It has long been recognized that adults who have naturally lower cholesterol levels during their 40s and 50s have less heart disease as they grow older. A large body of science supports the notion that LDL cholesterol levels lower than 130 mg/dL is an excellent goal for one and all. How a person should arrive at this goal is a matter of considerable debate. A good diet and exercise is the foundation for any person's health program and for many this approach is adequate.
The use of nutritional supplements to help lower cholesterol, products that have virtually no side effects and may be highly effective, is considered by the FDA to be an illegal health claim. Instead, the FDA expects Americans to use statin drugs to accomplish this goal, even though the medications have a general anti-energy effect and long list of potentially serious side effects that are not clearly explained to those taking the medications or even to the doctors giving them out.
To make matters worse, several years ago the government-funded National Cholesterol Education Program promoted new guidelines for the use of these drugs. It was recommended that individuals at high cardiovascular disease risk attain LDL levels < 100 mg/dL and individuals at very high cardiovascular risk attain LDL levels < 70 mg/dL. These are abnormally low levels of cholesterol, meaning drugs must be used to create an artificially low level of LDL cholesterol, an unnatural physiological condition. This is very difficult to do and requires high doses of statins, doubling or tripling the dose, oftentimes combined in dangerous combinations with other drugs (like fibrates).
These therapies are extremely expensive and often do not work. These guidelines immediately boosted the sales of statins from fifteen billion per year when the report was released in 2004 to over twenty-two billion in 2005. And now we come to find out there is not a shred of scientific evidence to support that lowering cholesterol in this manner will reduce cardiovascular disease, compared to simply having an LDL lower than 130.
Statins are also being pushed for prevention of a first heart attack in people with only moderate cardiovascular risk. A careful analysis of the statistical data shows that such statin use may very slightly reduce cardiovascular death in this preventive population over a ten year period. However, the drugs kill 1% as a side effect, due to accidents, suicide, and infection, completely canceling out any benefit. This means there is no value at all, from a societal point of view, in wasting billions of dollars of taxpayer money on this pointless preventive strategy.
The amount of money spent on this fraudulent scheme is at least seven billion dollars a year, money that is in essence stolen from hard working Americans. Class-action lawsuits have already been filed against Pfizer for illegal Lipitor promotion, many are sure to follow.
Big Pharma Concocts an Authentic Appearance
The National Cholesterol Education Program is part of the National Heart, Lung, and Blood Institute (NHLBI), meaning that it is part of our federal government and has an operating budget of about one million dollars per year. In 2004 it selected a panel of nine “experts” to review statin drug use and make recommendations as to guidelines doctors should follow to reduce cardiovascular disease.
On July 13, 2004, these nine experts published their findings in Circulation, a journal of the American Heart Association. Their paper lists the National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association as coauthors – meaning these various groups supported the findings. It doesn't appear to be very difficult to get published in your own marketing magazine.
Circulation failed to disclose that six of the nine authors had direct financial ties to the makers of statin drugs. Those drugs include Pfizer's Lipitor; Bristol-Myers Squibb's Pravachol, Merck's Lovastatin, and AstraZeneca's Crestor. For example, Newsday.com reported on July 14, 2004, “Dr. H. Bryan Brewer, a physician-scientist at the National Heart, Lung and Blood Institute, was one of the guidelines' authors. He was the subject of a letter to the director of the National Institutes of Health last week from a consumer watchdog, Public Citizen's Health Research Group. The advocacy organization charged that Brewer had failed to disclose his ties to AstraZeneca. Brewer, according to the letter, had written a glowing report in a medical journal about Crestor without disclosing that he is a paid consultant and had presided over a company-sponsored symposium.”
Even though these connections were slightly exposed in the media at the time, no action was taken to review the credibility of the statin science by other less biased researchers. Instead, the public relations buzz was that the statin “science” was solid.
The October 3 review in the Annals of Internal Medicine tears this “solid science” to shreds, something that should have been done two years ago. The review explains the deceitful manipulation of statistics and how not one study proves that lowering LDL cholesterol to the super low levels recommended has any benefit in reducing cardiovascular disease. Simply put, this report is shocking.
The bottom line: there is no credible science, and there never was, that offered proof that lowering cholesterol levels to physiologically abnormal levels reduced cardiovascular risk. Thus, basing a broad governmental public health recommendation on no solid science is flat out wrong. Why aren't these faulty recommendations being reversed?
The Extreme Dangers of Statin Drugs are Downplayed
In my book, Fight for Your Health: Exposing the FDA's Betrayal of America, I spend several chapters documenting all the clearly known risks of statin drugs, citing over 140 references. Even though it is the most widely used drug in America, most doctors prescribing it are not aware of its many side effects or numerous interactions with other drugs. Statins are known to disrupt energy production, weaken the adrenal glands, interrupt vitamin D synthesis, block co-enzyme Q10 production, induce cardiomyopathy, damage kidneys, weaken or damage muscles, and in a variety of situations increase cancer risk.
There are numerous reports of suicide, depression, and cognitive impairment from statin use. Since many elderly patients are using statins, brain damage with ongoing use is likely. This is not difficult for anyone to understand. Brain cells contain higher levels of cholesterol in their cell membranes, enabling nerve cells to survive longer. Nerve cells do not split and divide like other cells in the body, thus they must have a higher level of cholesterol – this is normal. One clear adverse effect of statins is lowering the nerve cell-membrane level of cholesterol, resulting in premature cellular death. Maintaining proper levels of cholesterol in the brain is vital to normal nerve function. This toxic effect of statins will be worse on a higher dose and nerve damage will progressively accumulate over time. Doctors, mostly unaware they could be inducing cognitive decline or neuropathy in their patients, may prescribe other brain medications to treat the decline in nervous system function, thinking the symptoms are just part of the aging process. This is a tragedy.
Another seldom mentioned adverse side effect of statins is that they directly interfere with immune system function. Statin pushers like to claim this is a benefit, reducing inflammation. There is an element of truth in this; however, there are much better ways to reduce inflammation than by use of statins that actually block immune signals. The same system being blocked by statins is required for a robust response to combat infection. The immune suppressing effects are so powerful that statins are being considered as adjunctive therapy for organ transplant patients. What happens to a person's immune defense when they are on a super high dose of statins to lower cholesterol to abnormally low levels? How is anybody on high-dose statin therapy supposed to fight the flu? What happens if a pandemic flu strain hits? Guess which citizens won't make it.
Mainstream Media Attempts to Brainwash Americans
A major part of the drug safety problem in the United States is that sleazy Big Pharma-sponsored studies are published as if they are science. Mainstream media forwards the Big Pharma sales pitch. This is done to blatantly promote the use of many dangerous drugs (like Vioxx), as well as to improperly discredit competition to drugs, i.e., the very safe nutritional supplements.
We hardly heard a peep from the mainstream media regarding these rather dramatic findings. The New York Times did manage to report on this issue; however, the reporting is more a defense of the status quo than a consumer wake-up call to a major health scam costing us billions of dollars.
Circulation is operated by the American Heart Association (AHA). All the big statin companies, Pfizer, Bristol-Myers Squibb, Merck, and AstraZeneca, pay big money to the AHA every year (so does Bayer for aspirin promotion). The AHA has a long history of taking in millions from statin-producing companies and other heart-drug producers, supporting questionable products in return. Once Big Pharma gets the slanted study published, the mainstream media is fed press releases and they promote the information to the unsuspecting public as if it is a major scientific discovery. Big Pharma pays several billion dollars a year for media advertising – you better believe the top media executives know where their bread is buttered.
During the time in 2004 that Big Pharma was plotting its statin bonanza it needed to fire cannonballs at its most widely recognized competition, Vitamin E and other antioxidants. No problem. First, in August 2004, they use their marketing magazine to print a bogus article, contradicting hundreds of nutritional studies, stating that antioxidants A, C, and E are not effective for cardiovascular disease risk reduction. Then, in November of 2004, with trumpets blaring at their yearly AHA meeting, they make the brazenly fraudulent claim that vitamin E increases the risk of death by 6%!!!
Outside the marketing meeting masquerading as a scientific conference, the chairman, Dr. Raymond Gibbons of the Mayo Clinic in Rochester, Minnesota, is holding a dog and pony show press conference. “I spend all my time trying to tell patients why they should not take vitamin E. Too often in terms of the supplements there's very scant science. In this area, we have the science. Vitamin E doesn't work.” He implored his captive audience of reporters to help him convince patients to stop taking Vitamin E and take the “proven” drugs. The next day, all major media ran the story telling consumers vitamin E was dangerous. Program effective. Damage done.
Within weeks the American Heart Association had brainwashed doctors and the American public to actually think vitamin E was dangerous, clearing out the primary competition to statins for the prevention and treatment of cardiovascular disease. Doctors were telling all their patients to stop taking vitamin E. The anti-vitamin rhetoric spread like wild fire through doctor's offices around the nation.
Within a week the bogus vitamin E information coming from the American Heart Association meeting was debunked. Physician and nutritional expert, Alan Gaby, pointed out all the flaws as well as the safe and effective track record of vitamin E. By April of 2006, the leading antioxidant scientists in the world had published a comprehensive review showing the safety of vitamin E up to doses of 1600 IU per day, again debunking the false vitamin E story and explain the high degree of safety of antioxidant nutrients. The media was nowhere to be found; the public never heard vitamin E was truly safe and vital for immune function, prevention of cognitive decline, and a wonderful nutrient for cardiovascular support.
In July of 2005, the Journal of the American Medical Association published the results of an amazing vitamin E and heart disease study. After tracking 40,000 women for eight years it was proven that vitamin E lowered the risk of cardiovascular death by 24%! However, JAMA authors, going along with the vitamin E smear campaign, concluded that vitamin E was not worth recommending! Any drug with that kind of statistical evidence would be a billion dollar blockbuster. The idiotic media failed to look at the study and reported everywhere that vitamin E was not needed, denying women the true information about a wonderful cardiovascular support nutrient.
It should not be surprising that the American Heart Association's bogus attack on vitamin E was rooted in their bogus science about the benefits of using statin drugs to lower LDL cholesterol to abnormally low physiological levels. The degree of collusion between the American Heart Association, Big Pharma, government agencies, scientific journals, and the media is simply appalling. The American Heart Association is now seen as the Big Pharma front group they truly are.
Where is the FDA when they are needed? Why isn't the FDA requiring more testing before allowing doctors to use statins in an unapproved manner? Why is the FDA attacking super-safe nutritional strategies to help Americans naturally and safely normalize cholesterol levels?
Consumers Really Do Have Choices
There is no short cut to healthy cholesterol function in the human body. Nutrition and exercise are the foundation. Many nutritional ingredients may be able to assist a person in their quest to improve their cholesterol levels. Despite this fact, the FDA is trying to trample the first amendment and prevent you from learning about these options; however, Americans do have choices.
There is good reason many Americans are turning to safe and effective natural options as part of a health strategy to maintain cholesterol levels in a better range. This latest fiasco with cholesterol medication is proof that government and Big Pharma work together to push drug sales, oftentimes disregarding the true effects on human health, including safety. I wonder if the American Heart Association will learn that those living in glass houses should not throw stones? How much longer can Americans tolerate a government, media, and health industry on the take from Big Pharma?
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