The Politics Of Health: Feature ArticleS1082 - What Is Really Going On At The FDAMonday, May 07, 2007Byron Richards, CCN 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. Americans are sick and tired of unelected bureaucrats, such as the management of the FDA, usurping our constitutional rights, suppressing our choices, interfering with commerce, and forcing on us a predetermined path that lines the pockets of the multinational corporations known as Big Pharma. The American people must wake up so that we do not consistently repeat the same mistakes that were made by our parents and grandparents, mistakes that created the current dilemma. We cannot and must not pass these problems on to our children and grandchildren. Yet, before us this very day, the Senate is proposing sweeping changes (S1082) that will affect the FDA, Big Pharma, and Big Biotech for the next 50 years. This legislation is as significant as the original creation of the FDA. I wish I could say that these changes were mostly positive, but that is just not the case. Many of the real problems are being completely ignored. Under the pretense of improved consumer safety, this legislation seeks to lock in the Big Pharma monopoly called the sickness industry – even taking it to a whole new level. S1082 is a major tool that will assist the FDA, Big Pharma, and Big Biotech in their overall plan to suppress, eliminate, or buy up all safe and effective natural health competition.
In order to empower the American public to understand what is going on, I am releasing my book, Fight for Your Health, to be read online FREE OF CHARGE. Right now is a moment in time, a window of chance, which is rapidly closing. We must understand and learn from the mistakes of the past and forge a different future. Your voice matters. We can make a difference. Unlike Humpty Dumpty, we can put our country, our constitution, our communities, and our freedoms back together again. Health freedom is fundamental to all other freedoms. Rise up and be heard. Click on this link to read Fight for Your Health.
PDUFA allows the very wealthy drug companies to pay fees to the FDA in order to have their drugs fast-tracked through FDA approval. There are numerous cases of the safety concerns of FDA scientists being overridden by FDA management to meet the time deadlines required by the PDUFA legislation. Additionally, such large sums of money coming from so few companies enables those companies to have considerable say in how they will be regulated. This is a major conflict of interest as well as a major safety issue. Last year Big Pharma paid the FDA 250 million in user fees, over 50% of the FDA’s budget for new drug approvals. Under S1082 this problem is made worse, raising Big Pharma contributions to 380 million, well over 50% of the FDA budget for new drug approvals. Shockingly, ALL SENATORS have decided that this arrangement is just fine. What gives these Senators the right to perpetuate such a safety scam and conflict of interest on the American people? How can any Senator claim S1082 is true and meaningful safety legislation when one of the key problems driving safety concerns is made worse! This is total hypocrisy. I am amazed that Congress can come up with 100 billion dollars a year to fund a war in Iraq but can’t fund the FDA to correctly evaluate the safety of new drugs (and even more importantly – the safety of drugs already on the market). To make matters worse, the Durbin amendment to S1082 (#1022, which passed on a vote of 94-0), directs the Secretary of Health and Human Services to conduct a study to figure out how to implement user fees in the food industry (which includes dietary supplement companies). I can tell you right now that unlike Big Pharma user fees, these user fees will drive up the cost of food and dietary supplements and run many smaller businesses out of business. Such money would have to be collected from many thousands of small companies as a form of tax, and in the case of dietary supplement companies will become part of an intentional FDA-harassment campaign to brand safe and effective dietary supplements as drugs. An underlying primary goal of the FDA is to help Big Pharma eliminate competition from the market. These user fees will be used in conjunction with draconian Adverse Event Reporting legislation that Hatch snuck through the Senate last year in the wee hours of the Lame Duck session. Our government should fund the FDA for adequate inspection of the safety of the food supply, including and especially food imports. The FDA should not become the next IRS. We need less bureaucratic bumbling with our freedom, not more.
In essence, the Senate’s desire to encourage the expansion of user fees to Big Pharma and its desire to expand them to the food industry is a sign that the Senate can no longer do its job of proper financial appropriations. By dumping government responsibility onto the private sector, not only is a costly bureaucratic nightmare created, but in the case of drugs – SERIOUS SAFETY ISSUES AND CONFLICT OF INTEREST ISSUES ARE PERPETUATED. This is one reason every American should flood the Senate calling for a no vote on S1082.
FDA has deviously worked with Big Pharma to create case law precedent around the country that forces the FDA to hide safety issues from the public so as not to expose the “trade secrets” of Big Pharma. How this happened is fully explained in Fight for Your Health. It is important to understand that the FDA has intentionally gone out of its way to create a situation that keeps American citizens in the dark – and the proposed S1082 does not change this. Furthermore, the FDA has taken the position that citizens of the United States of America should have NO RIGHTS to sue a drug company in state court when a drug injures or kills them. FDA is seeking to undermine the balance of power between the states and the federal government, while at the same time shooting down fundamental rights of citizens. In essence, FDA is taking a fascist/totalitarian approach. Why? Partly to prevent law suits and save Big Pharma money. And mostly because the FDA is planning on becoming a drug company and using its software as the centerpiece for the design of all new drugs through its Critical Path Initiative and the S1082-proposed Reagan-Udall Foundation for the FDA. What happens when new FDA-designed drugs start injuring and killing people? If citizens have the right to sue when they have been injured they will in fact be suing the FDA. The FDA’s “solution” to this problem is to wipe out citizen’s rights. The FDA is saying that if they do the testing and give their stamp of approval, then the public should trust that the FDA did an honest job of ensuring safety and thus give up any rights of recourse - regardless of what happens. First of all, nobody trusts the FDA. Second of all, this plan is insane. Yet, it is exactly what is being pushed off on us by the FDA. S1082, as written, not only ignores this issue entirely but gives FDA management dramatically more power and creates the Reagan-Udall Foundation for the FDA to implement the plan. Furthermore, FDA management is acting with a political agenda to forward globalization at the expense of health freedom in the United States. The FDA is actively helping to forge the North American Union through its illegal Trilateral Cooperation Charter with Mexico and Canada. If you have not already signed the petition demanding Congressional oversight on this issue, please do so by clicking on this link. The FDA is also seeking to harmonize United States laws to draconian Codex guidelines relating to dietary supplements so as to help eliminate competition for Big Pharma. This is also fully explained in Fight for Your Health. The important point to understand is that FDA management is acting politically AND WITHOUT CONGRESSIONAL MANDATE OR AUTHORITY to undermine the laws in our country – including an outright attack on our constitution and sovereignty. FDA is actually helping to carry out the globalization agendas of both the Clinton and Bush administrations, administrations that have both been owned by Big Pharma. Thus, there is no turning to one or the other political party to solve these problems – it can only be solved by Americans uniting together to stand up for our rights and preserve our national sovereignty and constitution. Your voice is clearly being heard. And we must keep flooding the Senate. There are now two letters that need to be e-mailed or faxed, as well as calling in to let your Senator’s know your feelings. The first letter relates to The People’s Amendment, which must be in place if this horrid package of legislation becomes law. It has been updated to reflect the fact that Durbin has put the word “food” into the legislation in multiple places. The second letter relates to being opposed to the legislation in general.
To get information on contacting your Senators, click here:
The Honorable (Senator First and Last Name)
Dear Senator Last Name; The issue of drug safety is of the utmost importance to myself and all Americans. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use S.1082 to undermine my access to safe and effective dietary supplements. 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 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. I am sure you and other Senators were not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with a simple amendment. Proposed amendment to S1082:
“The bill, S1082, is hereby amended to eliminate any reference to the terms food or food ingredients within Subtitle B - Reagan-Udall Foundation for the Food and Drug Administration, 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.
The Honorable (Senator First and Last Name)
Dear Senator Last Name; The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Prescription Drug User Fee Amendments of 2007, as it does not go far enough to protect myself and my family from the dangers of drugs. I am opposed to Big Pharma funding of the FDA. I want Congress, not private industry, to fund new drug approval as well as the safety of drugs already on the market. It is an intolerable conflict of interest AND SAFETY ISSUE to have Big Pharma paying the FDA to approve its own drugs. I want an independent office within the FDA to monitor the safety of drugs already on the market. FDA scientists must be free of all FDA management pressures and Big Pharma influence. I am in favor of all 11 Grassley amendments. I support the Dorgan amendment that enables Americans to get a fair price on prescription medication. I am opposed to the Reagan-Udall Foundation for the FDA, which supports the plans of the Critical Path Initiative, a plan that is officially on record wanting to speed new and even more powerful drugs to the market with far less safety and effectiveness testing than current medications. It is intolerable that Congress does not properly fund the FDA to approve new drugs, monitor the safety of drugs, and ensure a safe food supply. It is also intolerable that FDA management problems, as outlined in the Institute of Medicine report (which calls FDA management dysfunctional) are not being meaningfully addressed. S.1082 is Big Pharma preferred legislation. I want true and meaningful safety legislation that protects myself and my family. Please vote no on S1082.
Sincerely,
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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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