The Politics Of Health: Feature ArticleUS Health Freedom On Verge Of CollapseWednesday, April 25, 2007Byron Richards, CCN 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. S1082 is a Trojan Horse bill that pretends to address safety issues. Unbelievably, the bill turns the FDA into a drug development company that will expose Americans to new and dangerous biological drugs that have little testing to prove safety or effectiveness. And to top it off, the bill gives broad new regulatory powers to the FDA that can be used to frivolously attack dietary supplements and forward the FDA management’s anti-American globalization agenda.
On April 18, 2007, S1082 was approved by the HELP committee (which Kennedy and Enzi control) and now moves to the floor of the Senate. In a slick move, Kennedy has attached his long-planned FDA/Big Pharma “reform” measures to the renewal of PDUFA (Prescription Drug User Fee Act). Current PDUFA law expires later this year and must be reviewed by Congress. PDUFA allows Big Pharma to pay the FDA fees to speed the approval of its drugs. The new Kennedy bill will increase these FDA bribes to 380 million dollars in 2008, well over 50% of the FDA budget for new drug approvals. This is like paying the mob for protection. Kennedy, by replacing the existing PDUFA law with this new bill (S1082), is ensuring that his twisted legislation is the one that will be put before the Senate for a vote.
This new FDA business enterprise is called the Reagan-Udall Foundation for the Food and Drug Administration (see pages 105-125). In previous versions of the Kennedy bill it was going to be an independent drug company within the FDA (the Reagan-Udall Institute for Applied Biomedical Research). In the current bill it is a “non profit” collaboration of the FDA, private industry, government funding, and private funding. It is run directly by the FDA even though it pretends to not be part of the government. Under this scam taxpayers will foot the bill for drug development and then be charged outrageous prices for the drugs. Furthermore, the new bill seeks to allow a massive expanse of FDA regulatory power through this new foundation. For example, on pages 106-107 the bill states: “The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety….The Foundation shall [take] into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including post approval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.”
Through this foundation the FDA is seeking broad new regulatory power that it currently does not possess. This will include the authority to attack any dietary supplement (which are food ingredients) as unsafe based on its use of “Critical Path” technology. This means the FDA will use proteomics (the advanced study of proteins in biological systems) to assess changes in biomarkers (the change in the state of a protein at the molecular level) in order to establish whatever it wants to consider as a risk. The FDA can slant this technology, based on their own personal opinions, to make anything they want appear as a risk – including your favorite dietary supplements that you use to stay healthy.
While S1082 also pretends to address the issues of drug safety, in reality all the needed Big Pharma loopholes are firmly in place. Additionally, the establishment of a clinical trial database as written in this proposed law will enable Big Pharma to hide experimental and undesirable side effects. Instead of full disclosure we will have a sterilized clinical trial database that will have the net effect of being used as a tool by Big Pharma to promote off label use of drugs. This is a far cry from disclosure that results in safety. In response to the Kennedy con Charles Grassley (R-IA) immediately attacked the legislation on the floor of the Senate: “The bill [S1802] does not address the outstanding critical problem that the office responsible for post-market drug safety lacks the independence, lacks the authority to promptly identify serious health risks and take necessary steps that will protect the public. As I think we all agree, the FDA is in desperate need of major overhaul.” The problem for Grassley, and all Americans, is that his true safety reform measures for the FDA are being held hostage by the HELP committee which is under the control of Kennedy and Enzi. His proposed legislation is S. 468: Food and Drug Administration Safety Act of 2007 and S. 467: Fair Access to Clinical Trials Act of 2007. As Grassley told the Senate: “Let me be clear: Big Pharma does not like these bills. FDA management does not like these bills. Lobbyists are spending hours upon hours lobbying against these bills…What is wrong with establishing a separate center within the FDA--not outside the FDA, within the FDA--with its only job being that of a watchdog for those drugs already in the market?...What is wrong with supporting a clinical trial registry and results database that also requires sponsors to reveal their negative trials?...I propose there is nothing wrong with any of these proposals.”
The situation is rather grave for all Americans. Kennedy has attached repressive legislation to replace the PDUFA funding thereby ensuring that his agenda will come before the Senate for a vote. The only real opposition to the legislation is coming from Grassley, who is attacking the weakness in FDA reform regarding drug safety and clinical trials. An even greater threat to the public – turning the FDA into a drug company and creating new regulatory powers that can be used to attack dietary supplements and remove them from the market – is being ignored by everyone – until now. Kennedy knows he can defeat Grassley and keep Grassley’s bills from ever seeing the light of day. Can Kennedy defeat the American public? Solving this problem is up to you.
The anti-American FDA is actively seeking to undermine U.S. laws and harmonize our dietary supplement laws with Mexico and Canada. This is being done through the Trilateral Cooperation Charter – an illegal agreement set up with health regulatory agencies in Mexico and Canada. It is part of the campaign towards a North American Union, one which would be a catastrophe for health freedom in this country as dietary supplement laws in Canada and Mexico are far more restrictive than in the U.S. The FDA would also like to harmonize our dietary supplement laws with the evolving international standards set by Codex, thus branding therapeutic nutrition as dangerous and risky and needing to be sold by Big Pharma or removed from the market altogether (if it competes with a blockbuster category of drugs). Codex is planning to use the same proteomics and biomarker technology that will be used by the FDA’s Critical Path Initiative to remove therapeutic dietary supplements from the international market and force their policies on America, thereby superseding the sovereignty of American law on threat of trade sanctions. The FDA fully supports draconian Codex guidelines to regulate dietary supplements and is working with the Germans to concoct technology to brand nutrients as drugs. The FDA management is as bad as any government agency can get. Under the leadership of Andrew von Eschenbach it has plummeted to an all time low.
The issue of health freedom is an issue for all Americans who believe in our constitution and our founding documents. America is the last bastion of health freedom on earth. If we fall, the world will be plunged into a Dark Ages of health. Our future health will be dictated by a multinational sickness industry driven by profits for drug and biologic companies with little to do with real quality of health. This is a crossroads – a moment in time. Health freedom is fundamental to all other freedoms as without health freedom the minds and bodies of a population are easy to control.
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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).
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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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