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The Politics Of Health: Feature Article


A Bombshell Drops on Cholesterol Medication’s Glass House

Sunday, November 19, 2006

Byron Richards, CCN


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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.


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. A good diet 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 a very good reason the AHA was attacking vitamin E. One of the newer nutritional supplement forms of vitamin E, known as tocotrienols, is a powerful tool for managing cholesterol and boosting immunity. 100 mgs a day of rice bran tocotrienols have been shown to lower LDL cholesterol 25%. Tocotrienols are the only form of vitamin E that show some ability to reverse hardening in the arteries. They are known to effectively reduce plaque formation by preventing plaque from sticking to the lining of arteries. Instead of causing nerve damage like statins, they offer powerful antioxidant protection for nerves. Statins work by taking a sledge hammer to the cholesterol production line. Tocotrienols work by telling the workers on the production line to go home for the day, enough work has been done.
Nature provides us with hundreds of natural compounds that help cholesterol regulation. Any supplement that improves energy function, such as a good multiple vitamin, will have a synergistic benefit. Fiber, whether dietary or in the form of supplements, can help manage cholesterol. In some cases, a simple deficiency in magnesium can cause cholesterol to elevate. Magnesium is the most lacking mineral in the American diet. Omega 3 oils are also lacking in diets, and fish oil has been shown to lower cholesterol (study 1, study 2, study 3).

Whether it is a B vitamin like pantethine or niacin, a fruit extract from citrus or blueberries, or a simple condiment like garlic, the list of nutrients that may assist individuals to manage their cholesterol is almost endless. Nature has provided answers. You have many options.

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?


Other Feature Articles:


In an unprecedented change of posture the New England Journal of Medicine has reversed itself on the issue of whether Vytorin causes cancer.  In the initial release of data back in July NEJM stood by Merck and Schering-Plough, who hired an Oxford consultant to rule that a 50% statistically significant increased risk of cancer was by chance.  I pointed out in an earlier posting that such statistical manipulation, based primarily on the opinion of the Oxford reviewer, was ridiculous.  NEJM has had a sudden change of heart and now agrees with me.


The shocking death of Tim Russert last Friday has left an entire nation wondering what happened.  He was a model patient, doing everything his doctors asked.  All major media have run articles trying to explain the nuances and difficulties in treating coronary artery disease.  These articles find little fault in Russert’s care, trying to create the idea that his heart attack was just too hard to predict and that all that could have been done for him was done.  I beg to differ.  His death represents the failure of standard medical care to produce a positive result – an occurrence that is all too common in today’s world.


Legions of well wishers look on as Senator Ted Kennedy struggles for his life, fighting against one of the most difficult types of brain tumors.  Ironically, it may be the drugs he has so adamantly promoted that are the straw that broke the camel’s back, leading to his brain tumor.


The latest stone thrown at the 200-billion-dollar-a-year cell phone industry came from a study by neurosurgeon Vini G. Khurana entitled Mobile Phone-Brain Tumour: Public Health Advisory.  His meta-analysis of existing cell phone studies may not contain a lot of new information; but his rather alarming message was carried by media around the world: “there is a growing body of statistically significant evidence for a relationship between the overall length of use of a mobile phone and the delayed occurrence of a brain tumor on the same side of the head as the ‘preferred side’ for mobile phone usage.” He claimed a 2-4 fold increased risk following 10 years of regular use.


On April 2, 2008 CNN spent the day bringing awareness to the problem of autism.  Larry King’s segment, which included Jenny McCarthy along with a panel of guests, was particularly enlightening.  My hat is off to Jenny, a celebrity mother who is making it quite uncomfortable for the Center for Disease Control (CDC) to ignore parents of autistic children seeking answers.  Why does a mom have to do the work of the CDC?  The answer is rather simple:  our government’s zeal to insist on too many vaccines while ignoring the actual risks is the driving force behind the autism tragedy.


The Senate is about to approve legislation (Mothers Act – S.1375) which mandates the indoctrination of pregnant and nursing mothers into the use of extremely dangerous psychiatric medication.  We already know this class of medication poses serious health risks to both mother and baby.  Consequences to the baby are now proven to cause nerve-related changes that can adversely affect health for a lifetime.


Immediate Consumer Action is Needed to Stop Mothers Act

The Mothers Act is pending legislation that will indoctrinate hundreds of thousands of mothers into taking dangerous psych drugs.  It is a great example of how the Big Pharma lobby controls Congress to the detriment of health, as well as needlessly and dramatically inflating the costs of our health care system for everyone.  Like any piece of legislation it purports to address a troubling issue – in this case the mood distress of mothers following birth known as postpartum depression.  It is true that 10% - 15% of women need some assistance in dealing with this topic – but the majority of them sure don’t need it from Big Pharma.  That is the Big Lie. 


It now appears that the FDA Chief Andrew von Eschenbach, M.D. has committed perjury before Congress.  Unlike Roger Clemens, who also seems to be putting his foot in his mouth before Congress, von Eschenbach’s actions appeared to have allowed unnecessary deaths to Americans – hardly the mission of the FDA.  By contrast, Roger Clemens is simply causing death to his own reputation.  Hopefully Congress can quit wasting taxpayer money on baseball and get to the bottom of what is really going on at the FDA.


Several high profile human cardiovascular drug experiments have turned into disasters for Big Pharma.  These findings are sure to shake the misguided consumer confidence in drugs as a mainstay of preventive cardiovascular health.  Hanging in the balance are billions of dollars of fraudulent drug sales based on the flimsy argument that changing numbers (blood sugar, cholesterol, or blood pressure) with the use of toxic drugs is somehow the same as actually being healthy…


Women across the country are being duped to consume billions of dollars worth of bone poisons under the false pretense that if they take them long enough they will not develop osteoporosis.  Even the FDA is becoming alarmed by the side effects of these bone drugs.  The biggest selling drug in this class is called Fosamax, made by Merck – the very same company that killed thousands of Americans with Vioxx while hiding cardiovascular risks from the FDA and patients.  Does anyone trust them?…


Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media this month:  “Statins Found to Turn On Gene that Causes Muscle Damage.” It’s now a fact of science; a new study shows that taking statins destroys your muscle to a greater or lesser degree.  And let’s not forget that the heart is a muscle. 


On November 29, 2007 the FDA made a rather surprising, almost honest announcement.  It said that it could not protect Americans from the dangers of drugs.  A 56-page report by its Subcommittee on Science and Technology stated the FDA “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” This blistering report on the life-threatening shortcomings of the FDA was released with the stamp of approval of the head of the FDA, Commissioner Andrew von Eschenbach.  The flagrant disregard for human health by the FDA…


Oprah has done an immense favor to millions of American women by helping them understand that a malfunctioning thyroid gland may indeed be part of their weight and health problems. After writing openly about her thyroid problem in the October 2007 Oprah Magazine, she then went into the nature of thyroid problems on her TV show. 


The United States Health Freedom Assembly met October 12 – 14, 2007 at the William Mitchell College of Law in Saint Paul, MN, a gathering of many of the top state, federal, and international health freedom advocates, organizations, and industry.  The meeting took on a tone of extreme importance as the FDA has issued policy and obtained broad new regulatory authority over health freedom in the past 12 months.  The FDA is seeking to undermine the law known as DSHEA (Dietary Supplement Health and Education Act of 1994), the cornerstone of health freedom in America.  Emboldened by its new powers the FDA is now poised to trample the first amendment rights of companies and Americans who seek to explain or understand how nutrition can support health.  The FDA campaign has begun.


On Wednesday, July 11, 2007 the House passed HR.2900 without allowing the Ron Paul (R-TX) amendments to protect dietary supplements.  Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company. 


The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market.  The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs).  Within this 800 page rule the FDA states, “We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”  


Under the false pretense of improved food and drug safety the FDA is re-inventing itself as a kingpin drug company. This charade has so far hoodwinked virtually all members of Congress. The Senate has already approved this FDA transformation. The House will bring similar legislation out of committee next week, with a vote in the full House likely in July.


The Andrew von Eschenbach FDA era is upon us. The Avandia scandal is the tip of the iceberg. Is anyone ready? The words “illicit financial collusion” have been replaced by the politically correct term, “collaboration.”


The penalty in China is death, in America its business as usual. Zheng Xiaoyu, the former head of China’s FDA, was sentenced to death for accepting $832,000 in drug company bribes and for dereliction of duty. Like China, our country is in the middle of a drug and food safety crisis. Why is FDA Commissioner Andrew von Eschenbach, M.D. getting a free pass? Why did the Senate just pass legislation (S.1082) that gives von Eschenbach significantly more power to do whatever he pleases? And exactly what is it that von Eschenbach is doing?


Senate Attempts Damage Control – House Braces for Onslaught

Senators were taken off guard by the public outrage over the passing of bill S.1082 with language that can be used to seriously harass dietary supplements by enabling the FDA to apply drug-related risk analysis to the safety of food and food ingredients (and thus dietary supplements). 


The FDA is Acquiring New Powers to Suppress Alternative Health

Your right to have free access to safe and highly effective dietary supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the Supreme Court sided with the FDA by deciding not to hear the case of Nutraceutical v FDA, letting stand a federal appeals court ruling that permits the FDA to use drug-related risk/ benefit analysis to determine if a nutrient is safe. 


The Senate has sold out the American people. Anyone voting for change in the last election can now plainly see the shenanigans of a Democratic-controlled Senate. Under Republicans no FDA reform ever took place. Big Pharma owns so many Republicans that all meaningful legislation to curtail the deaths and injuries of American citizens at the hands of Big Pharma and the FDA had been completely thwarted for the past six years. Under Democratic control sweeping FDA reform favorable to Big Pharma was proposed and the majority of meaningful reform was blocked or seriously watered down. Which is worse? As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an “elaborate scheme.”


For approximately four days Americans lived in a delusional state that they may soon pay drug prices the same as every other country in the civilized world. Euphoria over breaking the Big Pharma monopoly turned to disgust as the chameleon, Senator Edward Kennedy (D-MA), changed sides and lead a contingency of Democrats against fellow Democrats lead by Byron Dorgan (D-ND). By passing the Cochran amendment the Dorgan amendment is poisoned and will no longer be effective. Maybe Democrats are now learning what Republicans have known for some time – you can’t trust Kennedy. 


In May of 2006, after months of research and investigation, I published my ominous findings in the book Fight for Your Health: Exposing the FDA’s Betrayal of America. Everything I predicted in this book is on the fast track to becoming reality. A majority of Americans, not informed on current events and unaware of the history involved, are silent. Mainstream media, one of Big Pharma’s largest clients, is silent. Only the power of the internet, which rivals the invention of the printing press in significance, is making it possible for individuals to understand what is going on. 


There is still time to stop FDA, Inc.

Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is known all over Capital Hill as Big Pharma-designed legislation. It is running into all sorts of credibility problems. A vote is likely on Monday – delayed due to all the opposition flooding the Senate by “we the people.”


S1082 Update – Tuesday’s Activity. Fight Erupts on Senate floor:

As the Senate continues to debate the Big Pharma-friendly sweeping reform of the FDA a new problem for Big Pharma’s prize Senators has erupted and quickly turned into confrontation on the floor of the Senate. At stake is at least 10 billion dollars per year in exorbitant Big Pharma profits. In one corner is Big Pharma-puppet Orrin Hatch (R-UT), representing the Kennedy/Enzi drug cartel. In the other corner is a majority of Senators lead by Byron Dorgan (D-ND). 


The combination of a lack of sun and cold weather invariably strains your mood as well as your metabolism. It is an energy-depleting form of stress, similar to having a daily argument with someone. If your energy systems…


S1082 Update – Monday’s Activity at the bottom of this article.

Bill S1082: The Food and Drug Administration Revitalization Act (also called the Prescription Drug User Fee Act of 2007) is one of the greatest scams and con jobs ever foisted on the American public. Current FDA management is grossly incompetent on the subject of drug safety.


A new attack against health freedom, drug safety, and dietary supplements was launched last week by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY). It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA’s dysfunctional management and legal team – meaning this legislation was written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH. 


Americans are up in arms that our pets are being injured and killed by a toxin sent to America by a Chinese company. Melamine, a toxic fertilizer used in China, is the suspected culprit behind the deaths and injuries to potentially hundreds of thousands of our pets. The FDA assures us that this toxin has not entered the human food supply – does anyone believe in the competence of the FDA? It is only a matter of time before this type of problem happens to humans, as the inept FDA has no control over imported food intended for humans, let alone pets. 


On February 13, 2007 the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations opened hearings lambasting the FDA regarding the safety of drugs. The opening statement by Chairman John Dingell (D-MI) set the tone, “It is clear … that the FDA is badly broken. I expect that before we finish this investigation, which is just getting underway, we will discover whether the problems we have found are due to the work of scoundrels, irrational penny-pinching, or because the doors to the FDA “hen house” have been thrown open to foxes. It may be a combination of all three.”


Wall Street, international bankers, President Bush, pharmaceutical companies, new biotech companies, the Rockefeller empire, and the FDA have created a new plan for public health. It is a grand vision based on profit. It will use the FDA and, as needed, the Department of Homeland Security as the regulatory police force that ensures compliance in the name of public safety. Legitimate objections may be overpowered in the name of national security. 


  • The FDA: An Agency Out Of Control - Part 1 of 2,

    The FDA is steamrolling its way to a grand vision of repressive health care based on profits for Big Pharma and new biotech companies at the expense of human health.
    Human death means little to the FDA, permitting mass killings of Americans while protecting Big Pharma profits. This year the FDA is being given more money (federal funding up 5% to 1.5 billion) without any accountability or effective Congressional oversight. This means that instead of using the money to meaningfully improve drug safety, the FDA will carry on its pet projects that include forwarding the health component of the Bush administration’s North American Union, limiting health freedom by harassing dietary supplement companies so as to reduce access to safe and effective drug competition, and actively turning the FDA into a drug company. 


    In the middle of the night the House passed a bill at the conclusion of the lame duck session known as Adverse Event Reporting legislation for dietary supplements (S.3546). The bill was pushed through the Senate and the House by Senator Orrin Hatch (R-UT), also known as the Hatch-et-man. Many Congressional leaders were hoodwinked by Hatch to back the bill, as he passed around letters of various trade organizations to imply the bill had wide support amongst stakeholders (it does not). Others were most likely bribed with threats to hold other legislation hostage in the Senate unless Hatch-et-man’s bill was passed in the House. 


    Benjamin Franklin and Thomas Jefferson not only rolled over in their graves, they had a stake driven through their coffins by the departing 109th Congress. Big Pharma is now fully in charge of the FDA. Therapeutic nutrition is now marked for elimination from the free market. How did this happen? What does it all mean? Why did the House Democrats, at 3:06 A.M., while Americans slept, stab our people in the back? It is an ominous sign of things to come. 


    Today I received an e-mail from the Natural Products Association (NPA) asking me to support the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER bill”). Apparently they do not know I am one of the most outspoken critics of this legislation. I have already posted two articles on this topic for NWV, one in July and one in November. The NPA, formerly the NNFA (National Nutritional Foods Association), is the largest trade association for ingredient suppliers and health food stores. This group, along with CRN (the Council for Responsible Nutrition) has been taken over by Big Pharma and is selling out the supplement industry. 


    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.”


    Last week Americans sent a warning shot into the oversized belly of the Republican Party. Unfortunately for President Bush, Americans turned out not to be the zombies he was counting on. This week Bush is trying to figure out why his public health goons forgot to double the fluoride content in the drinking water prior to the elections. Even Hitler knew this was the best way to make a population docile.


    I am amazed by the relentless attack of Big Pharma-controlled media on dietary supplements that help people lose weight. The FDA, colluding illegally with health officials in Mexico and Canada, has weight-loss fraud at the top of their list. The FDA is constantly insinuating that all weight-loss supplements are fraudulent and unproven, and they implore all consumers to beware. As one of the leading clinical nutritionists in this country and owner of Wellness Resources, an independent supplement company, I have over twenty years experience helping individuals lose weight with diet, exercise, and nutritional supplements. I’m more than happy to weigh in on this subject from my experienced point of view. 


    On October 19, 2006, the FDA fired off twenty-four warning letters to small nutrition companies that made claims they had natural remedies to help with diabetes. At first glance, one might think the FDA was actually doing its job. With tremendous bravado they announced to the world their trouncing of internet fraud. It is interesting how the FDA is now teaming up with Mexican and Canadian health authorities to attack American companies, part of the FDA’s illegal North American Union. 


    The FDA has created its own monster. Could it be that an FDA advisory panel actually has enough impartial members to be truly concerned about the health and well being of all Americans? No doubt, the top FDA officials were squirming in their boots as five current and past members of the Drug Safety and Risk Management Advisory Committee went public with their call for sweeping changes at the FDA.
    The October 9, 2006, issue of the Archives of Internal Medicine contains the article “FDA and Drug Safety: A Proposal for Sweeping Changes.” The lead author is Curt D. Furberg, M.D., Ph. D., an expert in epidemiology and biostatistics and current member of the FDA safety committee. He is a professor at the Department of Public Health Services, Wake Forest University School of Medicine. In an interview by Amanda Gardner, HealthDay reporter, Dr. Furberg states: 


    Americans are Injured and Killed by Drug
    The next Vioxx scandal has now landed on the FDA’s plate. A secret tip to the FDA forced Bayer to admit they had failed to disclose serious safety data. Bayer scientists recently testified before an FDA advisory panel investigating the company’s heart-surgery drug, Trasylol. They failed to mention a new study Bayer commissioned for the drug, one that contained highly unfavorable results.


    There he stood, a man with a captive audience of fellow anti-American neo-cons bent on one world government. His mission: to lay out the military and security integration of Canada, Mexico, and the United States. The date: September 13, 2006. The place: Banff Springs Hotel, Alberta, Canada. The forum: a secret meeting of the powerful elite, a meeting that all of a sudden become not so secret. The man: Donald Rumsfeld, point puppet for the Bush administration’s planned integration known as the North American Union. This is serious government collusion behind the backs of the citizens of the United States, Canada, and Mexico. It is government for the elite, not government representing the people. 


    Over one million Americans have been killed by Big Pharma in the last decade. Tens of millions have been seriously injured. Every person knows someone whose life has been damaged or snuffed out by Big Pharma. Consumers call for improved safety. Politicians pretending to respond to consumer outrage have now introduced legislation that, if passed, would create a new FDA—a Big Pharma FDA. At the same time, good legislation that would begin to address the multitude of major FDA problems has been scuttled. 


    On Friday, August 18, 2006, the FDA approved a viral cocktail to be sprayed on foods we eat. This is the first time viruses have been approved for use as food additives. The FDA wants you to believe it will be safe to consume these viruses every day for the rest of your life with no adverse health effects. This is a monumental announcement by the FDA, indicating they are throwing all caution to the wind regarding the safety of our food supply. 


    The FDA is now poised to dramatically change the health and well being of all Americans. Unfortunately, they are headed in the wrong direction—straight over a cliff. The FDA is supposed to make sure drugs are safe and effective; they are mandated to protect the public. However, the top two positions at the FDA are now headed by Big Pharma representatives. The Bush-appointed new FDA leadership is intent on removing any brakes being applied to the drug approval process, quite happy to turn ill Americans into human guinea pigs. 


    The United States government and especially the FDA have lost credibility in assisting you with your personal health. Instead, they have placed the vast resources of our federal government behind a twisted public health agenda that perpetuates the profits of the elite and the unspoken primary agenda of eugenics. The daily assault on American freedom is now like living in the twilight zone. Public health policy, under the guise of public benefit, is a primary tool of a despotic regime. It is a system designed to convince Americans to hand over their remaining freedoms, as a decayed government grapples to maintain control over its increasingly restless citizens. 


    By Byron J. Richards, CCN
    July 24, 2006

    Health is far and away a person’s most important asset. Protecting this asset from accelerated decay is no small challenge. Indeed, the cards are stacked against the individual.

    There are many obstacles to health. Our land, water, and air are heavily polluted with disease-provoking toxins. Our food supply contains various adulterations in the form of neuro-toxic pesticides, preservatives, coal-tar derived coloring agents, MSG, genetically modified food (that express the Bt toxin in every cell), excessively processed food, too much sugar/corn syrup and artificial chemical sweeteners, and high-fat junk food. Big Pharma promotes and excessively pushes toxic drugs on society, in far greater excess than their true need. 


    On July 19, 2006 President Bush employed his first presidential veto, rejecting a bill for the expansion of stem cell research. He told Americans stem cell research “crosses a moral boundary that our decent society needs to respect.” A close examination of the issue shows that this is merely a public relations ploy to preserve the profits of struggling Big Pharma and perpetuate the sickness industry at the expense of health improvements for millions of Americans. 


    The FDA has conveniently used the excuse of looking out for consumer safety to increase their perverse regulatory power, undermine free speech, disrupt commerce, and generally get in the way of helping people improve their health. The “half-truth” of the safety issue is used as a ploy to reduce the rights of Americans, one freedom at a time. Once again, the FDA is seeking more police power to intimidate supplement companies. 


    • The FDA Lowers The Boom On Citizens’ Rights,

      An ominous tone is now set as the FDA embarks upon its second hundred years. New drug labels, which have been in development for years and are intended to improve consumer safety, went into effect on June 30, 2006. In typical FDA fashion, a program that should have helped patients has been twisted. The FDA took this opportunity to sneak disclaimer language on the new labels, seeking to prevent patients from suing pharmaceutical companies if a drug injures or kills. 


      Today marks the one-hundred-year birthday of the FDA. To celebrate, the FDA plans a gala event at the Harvey W. Wiley federal building. The FDA is touting Dr. Wiley as the “Father of the Pure Food and Drugs Act,” inviting his decedents to attend their event. The FDA is quite proud of the heritage Dr. Wiley has bestowed upon them. 


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