The Politics Of Health: Feature ArticleHow the FDA is Becoming a Drug Company: Consumer Safety, Access to Natural Health Options ThreatenedWednesday, June 13, 2007Byron Richards, CCN 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 measure will then go to a conference committee to work out the differences. The final chapter in this transformation occurs when the Reagan-Udall Foundation for the FDA becomes law, which is scheduled to happen some time before September 30, 2007.
Even well-intended FDA employees are actively seeking new employment in more meaningful work. Such is the case with Rosemary Johann-Liang, former FDA deputy director of the Division of Drug Risk Evaluation. Last year she was reprimanded for trying to put a black box warning on Avandia, a move the FDA itself made last week in a damage-control effort to cover its complicity with GlaxoSmithKline. After 6 ½ years Johann-Liang is leaving the FDA. As the USA Today reports:
The 10,000 or so laid off Pfizer employees should cheer up, gainful employment for a legion of drug reps will soon be available through spin-off companies of the FDA’s Regan-Udall Foundation. Yes indeed, times are a changing. How Did this Happen? The Bush administration figured out that the fastest way to get the FDA out of the way of Big Pharma’s profits was to appoint FDA critics to key positions, thereby changing the FDA from within. This began in August of 2001 when Bush appointed Daniel Troy as chief counsel of the FDA, a man best known for defending tobacco companies. Mr. Troy invited Big Pharma to submit cases to him so that the FDA could help Big Pharma defeat citizens who were complaining that drugs and medical devices injured them. This has resulted in legal case precedent that ties up damage claim cases indefinitely and creates “trade secret laws” wherein the FDA claims it is legally obligated to withhold drug risks from the public to protect Big Pharma’s proprietary knowledge. Another active critic of the FDA, Scott Gottlieb, M.D.a Wall Street biotech sales rep and member of the American Enterprise Institute was invited into the FDA to rewrite its medical policy. Shortly after that Bush appointed him to the number two position at the FDA, even though he was a young and inexperienced physician with no expertise in drug safety – just a major agenda to bring unproven drugs to the market with far less safety or effectiveness testing for the benefits of Wall Street. These appointments were just warm-ups for Bush. His appointment that floored the drug-safety world and sent well-intentioned FDA employees running for cover was the appointment of Andrew von Eschenbach to head the FDA, an appointment that the Senate made permanent in last year’s Lame Duck session. The FDA is now headed by a representative of the pharmaceutical and biotech industries. It is informative to understand the chain of events enabling von Eschenbach to attempt his transformation of the FDA into a drug company. C-Change Andrew von Eschenbach is a founding member of C-Change, short for Cancer Change (originally called The National Dialogue on Cancer) – a group that was created and funded in 1998 by the American Cancer Society. This group has become a conglomeration of the most powerful players in the cancer treatment industry, as can readily be judged by looking at their member list. Their unstated goal is taking the national cancer agenda away from the public sector and placing it into private for-profit hands. The group is headed by former President Bush and his wife, Barbara. Until recently von Eschenbach was the vice chairman of the board. Since becoming permanent head of the FDA he relinquished his board position and is now only a member. Von Eschenbach is an oncologist by trade, a cancer survivor himself, and had a long career running the MD Anderson Cancer Center in Texas. He parlayed his close relationship with the Bushes and cancer-industry players into an appointment to head the National Cancer Institute (January 2002). And thus began the final stages in the transfer of power from public health interests to Big Pharma and Big Biotech. The initial and extensive C-Change conflicts of interest are fully explained in a revealing article on the Cancer Prevention Coalition website, including the assistance of tobacco companies and their PR firms in setting up this arrangement. On February 22, 2002, Diane Feinstein (D-CA), the only Senator that is a member of C-Change, introduced The National Cancer Act of 2002 (S.1976). While this legislation never became law, it was quite telling as regards the C-Change plan – to shift the national cancer agenda and funding away from the public interest and into the hands of the American Cancer Society, C-Change, and related pharmaceutical companies. Astonishingly, then director of Health and Human Services Tommy Thompson approved a waiver allowing von Eschenbach to remain vice chairman of C-Change while heading NCI, a dramatic conflict of interest. Tommy Thompson, like von Eschenbach, is a founding member of C-Change. During the von Eschenbach rein at NCI hundreds of millions of dollars in research grants were channeled to his C-Change friends and away from basic cancer research and public health measures relating to easily preventable cancers. As head of NCI, von Eschenbach reorganized its administration bringing in a new layer of management spearheaded by the chairperson of the C-Change cancer research team and former biotech CEO, Anna Barker, Ph.D. Part of this new team included C-Change member Mark Clanton, M.D., as deputy director for cancer care and delivery. This C-Change management team met behind closed doors, setting NCI priorities independent of NCI’s traditional scientific advisors. Von Eschenbach then funneled NCI money into Big Biotech projects relating to genomic-based cancer research, nanotechnology, proteomics, and the establishment of biomarkers relating to disease and cancer identification. While such innovative projects are on the one hand admirable, they are quite detached from the real-world issues that cause cancer in many Americans and are in many ways a diversion from what should be done now to realistically help many people not get cancer. Furthermore, there is no near-term tangible result. The problem for all of this type of research is how to get potential products to the market when the cost for drug development is so high and the FDA has no guidelines as to how these drugs even work or can be monitored for safety. The Critical Path Initiative The FDA “solution” to this problem, announced in March of 2004, was to set up a collaboration with industry to design the next generation of drugs. This plan is called the Critical Path Initiative and it refers to streamlining the path for approval to get new drugs on the market faster with less expense and less testing for safety or effectiveness. I would like to point out that the entire Critical Path Initiative, admirable as it may seem to some, is going to produce an increase in public health disasters like Vioxx. This is because the FDA (or more specifically von Eschenbach and friends) think the pharmaceutical industry’s problems are all based on a failure to get approval of new drugs fast enough. In reality, the pharmaceutical industry’s real problem is a failure to get results in the marketplace. When a new drug is approved very little is actually known about how it will perform in the real world. This problem is complicated by direct to consumer promotion that typically misrepresents the drug, massive off label promotion and use of the drug, and no system that monitors what is really happening with the drug as it is used. By rushing more drugs onto the market faster, the failure to get results issue will be magnified – and the safeguards proposed in S.1082 are inadequate. Any savings in the cost of bringing a drug to market will be offset by the costs of lawsuits related to damages. The FDA is trying to “solve” that problem by preventing citizens from suing drug companies when an FDA-approved drug injures or kills. Von Eschenbach and the FDA have pushed forward with this very misguided marketing strategy. In June of 2004 von Eschenbach’s NCI awarded SRI International a long term grant to evaluate the safety and pharmacology of these new biological drug cancer treatments. More related grants have followed. SRI specializes in cancer biology and toxicology research, as well as helping to patent, license, and spin off inventions into commercial applications. SRI also does extensive work for the Department of Defense and Homeland Security. Some of SRI’s largest clients besides government are the Rockefeller Foundation, the Ford Foundation, and the Bill and Melinda Gates Foundation. In March of 2005 the FDA announced its first Critical Path collaboration known as the C-Path Institute in Tucson, Arizona. This is collaboration between the University of Arizona, the FDA, and SRI International. One of its first projects is the establishment of cardiovascular biomarkers, working in conjunction with the University of Utah. Following this announcement the governors of the States of Arizona and Utah joined C-Change. Conflict of interest reached a new level in October of 2005 when President Bush appointed von Eschenbach as temporary head of the FDA, a position he took while maintaining his roles as head of NCI and as vice chairman of the board of C-Change.
The Reagan-Udall Foundation for the FDA
This year, Kennedy and Enzi tacked this piece of legislation onto required FDA funding, lumping numerous FDA issues into one huge bill (S.1082) and telling everyone it is a safety bill. Within this new legislation is the creation of the Reagan-Udall Foundation for the FDA, set up as an independent non-profit Foundation that will be under the control of the FDA. The Senate fought bitterly over various drug-safety issues unrelated to the Reagan-Udall Foundation, as if these issues acted as a smoke screen to slip past members of the Senate the creation of the Reagan-Udall Foundation for the FDA, the von Eschenbach dream come true. Not a single Senator raised one concern about the significant safety issues inherent in the Critical Path Initiative/Reagan-Udall Foundation or conflicts of interest when Big Pharma and the FDA work side by side to develop, patent, and license drugs. The entire history of von Eschenbach’s relationship with Big Pharma, Big Biotech, and C-Change has been conveniently ignored. This issue now moves to the House, where it will be interesting to see if Representatives are as poorly informed as Senators as to what is actually going on. Yes, the FDA is going into the drug development business. According to Senate bill S.1082, 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. It will do this by taking 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 postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics. The board of directors is composed of four primary members: the Commissioner of the FDA, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Director of the Agency for Healthcare Research and Quality. These members will then select the remaining board members to be composed of 4 representatives from Big Pharma and Big Biotech, 3 representatives from academia (which is funded by Big Pharma), 2 more from the FDA and NIH, 2 from consumers groups, and 1 from health care providers. This means that the FDA/Big Pharma/Big Biotech voting block always has 13 votes – to at the most 3. An executive director of the Foundation will be appointed by the board and serve at the pleasure of the board. The bill says the Foundation will ensure that “action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and (C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation.” Since the Foundation is responding to the needs of the Critical Path Initiative, and that initiative is primarily about the development of new drugs, it is clear that the Foundation will not only help with drug development but it will have significant business relationships as a result. Do not be confused by the Foundation’s non-profit status, this is simply a useful vehicle that SRI International has used to coordinate collaboration while securing patents and licenses and then spinning off business ventures. The FDA is trying to reduce its legal liability to the federal government by setting up the Regan-Udall Foundation as a non-profit, in case the drugs it helps design injure or kill people. Make no mistake about it, the FDA will be fully in control of the Reagan-Udall Foundation for the FDA. Once this becomes law, as anticipated by September 30, 2007, we will enter a new era with the FDA as a quasi drug company. A Safety Nightmare It is indeed disturbing that SRI International is intimately involved with the drug development process and has equally extensive connections with Homeland Security and the Defense Department. It will be far easier to make biological weapons that disrupt gene function than it will be to cure anything, in terms of initial applications of Critical Path technology. Indeed, this is an international problem and could cause an arms race of a new sort, as the Reagan-Udall licensed technology moves out into the world and not only creates a generic biotech drug industry but a generic biotech military industry. It would be responsible for the Congress to actually consider this problem before letting the Jeanie out of the bottle. On the drug development side von Eschenbach plans to replace clinical trials that show positive outcomes such as true improvement in the medical condition or improved life expectancy with studies based on biomarkers or surrogate endpoints. Biomarkers are like sign posts that point the way, but do not guarantee that anything positive is actually happening. This concept lowers the safety and effectiveness testing required to get an approval, a key theme of the Critical Path Initiative. This use of biomarkers, in and of itself, represents a drastic reduction in safety for Americans. One example of this problem is the Avandia scandal, wherein the drug was approved based on its ability to lower blood sugar (a surrogate endpoint or biomarker). It turns out that the drug does so while increasing the risk for heart failure, heart attack, and mortality. Over an eight year period it was turned into a blockbuster drug with sales of 3.2 billion a year. During this time the FDA sat on the known risks and did almost nothing to determine the aftermarket safety of the drug. The problem was actually exposed by an independent researcher. Based on last year’s drug sales and the increased risk for heart attack, it is likely that 35,000 people needlessly died last year alone. How will independent researchers expose problems in the future when all of the advance technology required to evaluate the issue is part of an FDA-controlled monopoly? Biotech drugs are inherently dangerous as they throw gene switches and powerfully influence functions of the body. Our understanding of what we are doing is in its infancy. This is like having the discovery of matches to light fires and not having any firefighting equipment or technology. Take the biotech company Amgen, with annual sales of 14.3 billion in 2006, and nearly half that revenue coming from two biotech drugs, Epogen and Aranesp, used in kidney disease. Aranesp is the blockbuster with 4.1 billion in sales for 2006, and is also used to treat anemia during chemotherapy. Amgen stock and sales are taking a beating as it is now coming to light that these drugs pose a significant risk for increased death when used, and doctors keep using them in an inappropriate way even though the FDA has warned them not to. The FDA is scrambling to contain the damage the drug is causing without making Amgen look bad. Otherwise, the whole fast track approval of new biotech drugs as envisioned by the Critical Path Initiative and Reagan-Udall Foundation is in jeopardy. This is because these Amgen drugs were approved by the FDA based on biomarkers, not based on improved patient outcomes. An FDA Advisory panel was surprised to find how little testing Amgen did to demonstrate these drugs are safe or actually improve the patient’s health. Amgen has a long history of involvement with the American Cancer Society and its fundraising activities. Will an FDA chief that is beholden to the same circle of friends and a true believer in what Amgen stands for actually be able to objectively regulate the company and protect patients from danger? Or will the profits of the drug company and image of the Critical Path Initiative be more important? The Loss of Patient Centered Care There was a time when a patient walking into the doctor’s office actually had a meaningful conversation. The amount of time spent and the type of lab work or diagnostics performed were not constrained by managed care. To the best of the doctor’s ability, the patient was given personalized care in the best interest of the patient. Patient centered care has been replaced by time constraints, minimized diagnostics, and maximized dispensing of questionable drugs. All of these problems are about to get significantly worse, as we enter the new era of von Eschenbach’s concept of personalized medicine, based on genomics and proteomics. Initially, a flood of new biotech drugs will hit the market, resulting in numerous Avandia and Vioxx-like scandals, which in some cases may take several years to identify. Congress, with 20-20 hindsight, will hold hearings that will result in legislation to improve safety. Von Eschenbach will tell Congress that the fault is not the drugs. Rather, it is the inability to personalize those drugs to specific patients that is the problem. Von Eschenbach would love to say that today, but he knows he doesn’t have the technology ready to implement this plan as he will in five years. Thus, he is willing to put the lives of hundreds of thousands of innocent Americans in jeopardy by exposure to barely tested biotech drugs and recklessly push forward with his Critical Path Initiative plan. The Von Eschenbach solution will be to evaluate the blood of every patient taking the drug with the FDA’s sophisticated biomarker software. The FDA has already developed the early stages of this software and will continue to perfect its new system of medicine over the next decade. Making a long story short, in order to receive medical care your blood will be evaluated by an FDA-controlled super computer, your genes will be profiled, your genetic weaknesses will be part of your medical record, and you will have an RFID chip in your arm storing your complex biological medical records, tracking your vital signs, and monitoring your whereabouts. If doctors think they have it bad now just wait until they become slaves to the FDA computer’s directions and drug prescriptions – which will no doubt be the latest and most expensive biotech drug experiment.
Loss of Health Options
While any person is in favor of the FDA being able to better identify contamination in food, such as infectious E.coli, assessing the safety of food and food ingredients is an entirely different matter. Similar language has been written into S.1082 in the section on the Reagan-Udall Foundation for the FDA, meaning the FDA is seeking to have it written into law that it can use Critical Path toxicology assessment to determine the safety of food ingredients (i.e., dietary supplements). This becomes a vehicle for the FDA to be able to remove any dietary supplement it desires from the market at its whim. The supplements most likely to be removed are those that compete with Big Pharma and Big Biotech drugs, especially those drugs produced by the Reagan-Udall Foundation itself. S.1082 already contains the troublesome wording. The battle now moves to the House where it is vital to get an amendment into this legislation that will protect dietary supplements without interfering with the FDA’s ability to identify true food contamination problems. This amendment has been prepared by Jonathan Emord, our nation’s top health freedom attorney. To keep up to date on this legislation and to help preserve your access to dietary supplements, send an email to your Senators and Representative by clicking here. A great deal will be happening in the next month or two on this legislation, which will determine the future of health care safety and quality for many years to come. Ideally, the Reagan-Udall Foundation for the FDA should be removed from this legislation altogether until the technology is ready and the safety can be assured. Realistically, both the Senate and House are going to pass this legislation with the Reagan-Udall Foundation in the bill – unless massive public protest occurs.
Assuming that the Reagan-Udall Foundation does move forward, strong language will need to be in this legislation to preserve health freedom and protect consumers from having dietary supplements evaluated using drug-related risk benefit analysis. In addition to the Emord amendment it will be essential to protect ourselves from the FDA’s internal conflicts of interest that pervade the agency. As things are now the FDA is more concerned about looking good and protecting its image than it is about drug safety or allowing unfettered access to safe and effective forms of natural health options. Alternative therapies and dietary supplements are the true competition to the FDA’s Big Pharma and Big Biotech medical model it is seeking to cram down the throats of all Americans. Stay tuned – more to come.
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.
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