The Politics Of Health: Feature ArticleThe FDA - A Wolf In Sheep’s ClothingFriday, July 07, 2006Byron Richards, CCN 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. This is one step in an overall FDA master plan to eliminate therapeutic nutritional supplements from the free market. Those who lose are the American public. The newest piece of supplement-harassing legislation is the brainchild of vitamin-hating Senator Richard Durbin (D-IL), perennial attacker of the supplement industry. S 3546, Dietary Supplement and Nonprescription Drug Consumer Protection Act, is known as Adverse Event Reporting (AER) legislation. It was introduced in the Senate on June 21, 2006, by Senator Orin Hatch (R-UT), former supporter of the supplement industry now turned gutless compromiser. It is backed by large supplement industry spin groups like the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA). CRN and NNFA have been infiltrated by Big Pharma and march to the drum of globalization and the New World Order. Like Hatch, these groups have placed themselves in a position of speaking for the supplement industry. Unfortunately, they are rapidly taking on the colors of the enemy. The PR spin suggesting a “need” for this legislation is to protect consumers and give consumers confidence in the supplement industry. The only reason for any lack of consumer confidence is due to a relentless and fraudulent persecution of supplements by the controlled media acting on behalf of the sickness industry. It is an attempt to divert public attention from the real safety issue of dangerous drugs that kill several thousand Americans per week. Big Pharma is terrified that the American public will flock to natural health options instead of options that have death as a side effect. Under the proposed legislation supplement manufacturers and distributors would be required to report to the FDA serious adverse reactions such as death or inpatient hospitalization. Such requirements seem plausible to any person with common sense; however, it is already a simple matter to file an adverse event report for any drug, medical device, or dietary supplement. The FDA’s MedWatch program offers a toll free number. Forms for filing complaints are readily available on their website. Furthermore, supplements are so safe such reactions are very infrequent. Why is legislation needed for a nonexistent problem?
The way the legislation is written a person could blame vitamins for almost anything, even if they are on multiple drugs or have pre-existing serious health problems. While the legislation states that the need to file a serious adverse event report is not an admission of guilt, some feel it will lead to frivolous law suits.
1. The FDA will charge supplement companies user fees for AER functions (as they currently do with drug companies). 2. The FDA will use supplements as a scapegoat for adverse effects that are caused by drugs. 3. Agreeing to such legislation implies there is an actual need for it. This shifts the burden of proof from government to supplement companies, undermining free commerce, citizen’s rights, and existing legislation that protects consumer access to health options (DSHEA). 4. The legislation will be a springboard for future FDA efforts to regulate supplements as prescription drugs and implement draconian Codex supplement guidelines, plunging alternative health for Americans into the Dark Ages. If all that isn’t bad enough, tucked into the legislation is a requirement for supplement companies to keep records of any adverse event reported to them for the past six years. The bill says, “The term adverse event means any health-related event associated with the use of a dietary supplement that is adverse.” This is far different than a serious adverse event. In another words, any symptom a person associates with taking a vitamin that in their opinion is improper will need to be recorded as an adverse event. Such reports need to be open for FDA inspection at any time. This legislation is nothing more than an FDA harassment vehicle.
As the owner of a nutritional company, Wellness Resources, and a clinician with twenty years of experience working with supplements, I can tell you that such a requirement is absolutely absurd.
Take the simple fact that half of Americans have digestive problems. The overuse of antibiotics and sugar-laden diets make us the world leaders in gas, bloating, indigestion, and constipation. No country in the world can beat us in antacid and laxative use. One example is the common problem of Candida albicans (a digestive yeast infection) occurring after antibiotic use, especially recurring antibiotic use. This issue is at epidemic levels in America, a problem caused by incompetent medical care. It can ruin lives, sending people down a path of chronic problems with digestion, sinuses, allergies, thyroid function, autoimmune problems, depression, and fatigue. In small children it can easily cause a life of asthma or lead to serious learning, developmental, immunological, or mental disorders. Since doctors appear virtually incapable of recognizing the problem or helping a person recover, and they typically create the problem in the first place, patients frequently turn to alternative health. Thankfully for many, the proper use of vitamins and diet can restore health and prevent what may otherwise be a lifetime of misery. Under current FDA repression of free speech, we aren’t supposed to tell someone what their problem is or how supplements can help them. Those with MDiety syndrome deny the problem even exists! People with Candida frequently have various symptoms that come and go and could easily be considered adverse, both because of the problem itself and due to the process of normal recovery (which can be likened to pulling weeds out of a lawn, wherein the lawn is the digestive tract). Under the proposed legislation, if a person gets nauseous or a headache after taking a supplement (which is referred to as “die off” and a relatively common occurrence), and complains about it, we would have to record it as an adverse event. Soon, the supplements that truly help people would be gone. Of course, individuals with Candida get headaches and nausea from eating sugar, consuming artificial sweeteners, or drinking alcohol. In this case, these substances are actually making them worse. Shouldn’t the entire food industry have to keep track of “adverse” events? As a supplement company I will incur costs trying to explain to people what their symptoms mean so as to prevent having to file an adverse event report, keeping track of symptoms in a six year file, and defending myself from FDA harassment. The burden of proof for the safety of supplement products will shift from the government to the supplement companies, counter to existing law. Needless cost will be passed on to the consumer. Much worse, truly helpful supplements will be targeted for removal from the market so as to eliminate competition for drugs (the true FDA intent).
Sooner or later I will be asking myself, why should I bother trying to help anybody? And that is exactly what the FDA would like me to think. The FDA does not want useful supplements as a health option for the American public. Candida albicans is one of many similar issues, like fibromyalgia, depressed immunity, and chronic fatigue. Tens of millions of Americans are suffering at the hands of the inept medical care of the sickness industry. In many cases, high quality nutrition offers a true option for a return to health.
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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.
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