The Politics Of Health: Feature ArticleDietary Supplements Threatened, Freedom In DangerMonday, April 30, 2007Byron Richards, CCN S1082 Update – Monday’s Activity at the bottom of this article.
Bill S1082 pretends to address drug safety while in fact proposing a set of laws that helps hide existing risks while ushering in the next generation of extreme drug risk (the Critical Path Initiative). At the same time the bill dramatically broadens FDA regulatory power to attack dietary supplements and health freedom. On the afternoon of April 30, a Unanimous Consent Agreement on S1082 is scheduled for 4:15 PM eastern time. Senator Kennedy, who is in charge of the HELP committee that has sent this bill to the Senate floor, is seeking to fast track this legislation through the Senate on a voice vote before anyone figures out what he is doing. Kennedy reported in the Congressional Record on April 24 that he filed a committee report on S1082; however, when the HELP committee office was contacted late Friday they were unaware of any report and did not have one - WHICH MEANS THAT ALMOST NO SENATOR WHO IS EXPECTED TO VOTE ON MONDAY TRULY KNOWS WHAT IS IN THIS BILL. Kennedy is seeking to run a secret government and bypass the Advise and Consent Clause of Article Two of the United States Constitution. This is not democracy. As things stand right now, the bill is expected to pass by voice vote based on the propaganda of Kennedy, Enzi, Clinton, and many others. This is a bipartisan hoodwinking of the American public being paid for by Big Pharma. Big Pharma and the dysfunctional FDA management have spent over two years crafting this bill. Not only does the bill fail to solve key drug safety issues, IT TURNS THE FDA INTO A DRUG DEVELOPMENT COMPANY.
Immediate action is required in the Senate, and if the bill should pass, in the House. E-mail, phone, and fax your Senators and Representatives – please do all three! Big Pharma is spending millions to pass this legislation. It is up to the American people to stop it. Also see the additional action step following the sample letter.
Anti S.1082 Food and Drug Revitalization Act
The Honorable (Senator or Representative First and Last Name)
Dear Senator (or Dear Representative) Last Name; The issue of drug safety is of the utmost importance to myself and all Americans. I am totally opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as well as any companion bill that is introduced in the House. I am dismayed that the HELP committee has not provided a report on this bill for your staff to study and that you are not aware of many dangerous consequences within this legislation. As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements – which has nothing whatsoever to do with drug safety. It is vital that the terms “food” and “food ingredients” be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. This bill authorizes, on pages 106-107, the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. Often, I feel that the FDA is working to protect Big Pharma and eliminate safe and effective natural health options. By removing the terms food and food ingredients from this legislation there can be no confusion of drug regulation with food regulation.
Indeed, there are many shortcomings in this legislation. The following points need a much more open and public debate, and thorough testimony in the Senate:
S1082 is seeking to do far too much without true and meaningful FDA reform. Minimally, I want the terms “food” and “food ingredients” removed from this legislation. However, I ask you to vote no on the entire bill, because, as written, it will not prevent another Vioxx catastrophe. Sincerely,
The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Reagan-Udall Foundation for the Food and Drug Administration.
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.
Con Job Unfolding – New Threat to Dietary Supplements Emerges
On Monday, April 30, 2007, Senator Edward Kennedy, consistently stumbling on his words and unable to look up (its hard to look anyone in the eye or speak clearly when you are lying through your teeth), sought to convince the American public that bill S1082 was true and meaningful drug safety reform. The latest information is that Kennedy and Enzi will now consider various amendments to S1082, which may last a day or two. Kennedy will evaluate these amendments, not on the basis of meaningful reform, but on the basis of how many votes he needs in order to get S1082 to pass. He is expected to reject Senator Grassley’s meaningful drug-safety amendments – there could be some fireworks (tune in to C Span if you want to watch). A full Senate vote could happen tomorrow, although it is most likely to be later this week.
Don’t be deceived, this is Big Pharma backed legislation concocted in close harmony with the dysfunctional FDA management team and is designed specifically to bring riskier medications onto the market with hardly any safety or effectiveness testing. As Kennedy and Enzi both stated on the floor of the Senate today – drug safety will now depend on the FDA linking to health care databases and looking for trends. Yes, that’s right, the inept FDA will now track safety “real time” as the drug companies perform their experiments on the public. In other words, the practice of medicine will now officially be one large clinical trial.
Other Feature Articles:
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.
News Categories:
Highlights |
| Home > Health News > The Politics Of Health: Feature Article |
