The Politics Of Health: Feature ArticleFDA Sleeps While Common Medications Poison the ElderlyThursday, December 06, 2007Byron Richards, CCN 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 is not news to people who follow the subject closely. The FDA has been mostly dormant while 100,000 Americans die needlessly from drugs every year and another 3 million are injured so seriously they require hospitalization (half of those were already in the hospital!). The FDA management’s neglect of duty and follow up on drugs already on the market is unconscionable and has been for a long time. The reason the FDA report is only “almost honest” is because the report is little more than a fear-driven PR ploy by von Eschenbach to raise hundreds of millions of dollars from Congress with no strings attached; a lobbying campaign that is actively under way as you read this. Such money will not change the FDA because the FDA management is a corrupt revolving door with the industries it is supposed to be regulating. Rather, any new money will be used to further pie-in-the-sky research initiatives crafted by von Eschenbach to create profits for the cancer and sickness industry with new and very dangerous biotech drugs (he already undermined the scientific integrity of the National Cancer Institute using the same approach). Drug Toxicity is a Public Health Crisis The use of drugs as a primary tool of health care in our society is a hundred-billion-dollar-a-year scam, as well as a direct and dire danger to the health of anyone taking almost any medication for any period of time. On top of that, American citizens are being raped by excessive drug prices compared to any other country in the world. It is an acknowledged fact that the FDA has almost no clue of the actual risks of commonly used drugs on the market today and has totally failed the American public on post-market safety of drugs. Drug companies do everything in their power to suppress risk information and paint a false picture of benefits – even when they know their drugs needlessly kill or injure. “Scientific articles” that show the “effectiveness” of drugs are little more than Big Pharma-written promo pieces that generate billions in sales. It is common practice for drug companies to illegally promote the off label use of drugs, even to our children. A legion of doctors on the take from and trained by Big Pharma is happy to comply. And the major media, paid in the billions for drug ads, carefully protects Big Pharma and perpetuates the false value of drugs. A majority of Congress is on the take from the Big Pharma lobby, and the White House is their best friend. Multi-national Big Pharma companies are playing Russian Roulette with the health of Americans and those responsible for protecting the public are complicit in the atrocity. The toxicity of commonly used drugs is a serious issue. There are anti-energy drugs like statins to lower cholesterol that are slow and deleterious poisons, progressively and insidiously worsening health over time. This 20-billion-a-year statin industry maintains its charade through a carefully orchestrated public health image of false benefit. In the elderly population statins clearly increase the risk of death and giving them cannot be justified for the great majority that is currently having them crammed down their throats. I’ll write more about this ongoing statin debacle in an upcoming article. Then there are the drugs that are so dangerous they are oftentimes immediately toxic. A new study in the Annals of Internal Medicine shows that three common drugs are responsible for 1/3 of all emergency room adverse drug reaction visits by the elderly (age 65 and over). The drugs are Coumadin/warfarin (17.3%), insulin (13.0%), and digoxin (3.2%). Since warfarin is the worst offender I will use it as an example to illustrate my points – though it is just as easy to explain similar problems with insulin or digoxin. Warfarin – A Practice-Building Drug Given to Promote Recurring Office Visits It is not at all surprising that warfarin heads the list of drugs sending the elderly to the emergency room. This drug works by poisoning vitamin K receptors on platelets so that they cannot stick together – the hope is to prevent a stroke. It is commonly given to elderly individuals with atrial fibrillation and according to carefully crafted “studies” may reduce their risk of stroke a paltry few percentage points. It is a cash cow for the prescribing physician, as it keeps patients coming back to the office to have their clotting times tested to make sure their artificially-produced clotting time is in a range deemed desirable by the doctor. Most elderly individuals with atrial fibrillation are in poor health in general, making this a difficult patient population fraught with the risks inherent in multiple drug use. Excessive bleeding is a primary side effect of warfarin. It is not surprising that you can buy warfarin in the rat poison department at Home Depot. A high dose is very effective at making animals bleed to death. There is a fine line between a Home Depot dose and what doctors prescribe. This means that if you are taking warfarin and rupture a blood vessel in your brain (say from high blood pressure) your body may not be able to clot to save your life – as was the case with former Israeli Prime Minister Ariel Sharon. Hemorrhage-related strokes have quadrupled in the past decade, consistent with the rise in expanded warfarin use. The warfarin/hemorrhage risk goes up 45 fold if the person is 80 or older. Also, if an elderly person on warfarin gets in a car accident and starts bleeding they may have great trouble stopping – especially if the bleeding is internal. Most discussions of drug benefits revolve around statistically concocted benefits of the drug, often in hand-picked patient populations, as is the case with warfarin stroke benefit studies. The studies are funded by drug companies, and if they don’t pan out or the statistics can’t be manipulated in some way to look good then they are thrown in the trash and never published. The benefits of drugs are never explained in terms of how the drug changes the body into a healthier state and solves the source of a problem – because drugs seldom ever do this. Drugs are about symptom and number management, and trying to titrate the poisons so they are not too toxic for something else that isn’t supposed to be damaged (a near impossible task). Warfarin is not only poisoning vitamin K function on platelets it is poisoning vitamin K function throughout the body. Doing so is very reckless and never considered by the myopic medical profession. Vitamin K is a potent antioxidant that is vital for health and participates in synergistic antioxidant activities throughout the body that are needed for more types of healthy function than any doctor could calculate. Vitamin K is required to attach calcium to bone structure to form new bone, something warfarin blocks. This means that warfarin use over time increases the risk for osteoporosis. It is now reported that use of warfarin for longer than 1 year increases the risk of bone fractures by 25% - a risk that is not explained to anyone taking warfarin. Unfortunately, when warfarin displaces calcium and interferes with normal vitamin K function it has the undesirable side effect of causing calcium to accumulate in arteries – otherwise known as hardening of the arteries or arteriosclerosis. This will speed the process of poor cardiovascular health, the same topic the drug is being given to assist. Thus, we have a medical profession that thinks if they see an unnaturally-produced clotting time on paper they have somehow reduced the risk of a clot-related stroke. Such a conclusion warrants an IQ score of 80 – and that’s the good news. At least 30,000 of their patients per year wind up in the emergency room with bleeding-related problems. Even worse, at least that number ends up with a warfarin-produced hemorrhage stroke. And for those that survive those odds, the risk of fracture and hardening of the arteries also elevates. While any of these issues would be very important to an elderly person, the risks are seldom clearly discussed. Instead, doctors insist their elderly patients stay on this medication and keep coming back for office visits to measure their clotting times, using “fear of stroke” to gain compliance. It is easy to conclude that the only discernible public health benefit is the money earned by the physician for repeat office visits. What if Doctors Could Think? If doctors had some actual training on how to make people healthy and could stretch their imaginations to ask the most basic of questions then maybe they would actually be able to help their patients. What if they asked: Why does this patient have atrial fibrillation? Or, why does this patient have sticky platelets? Or, how could I help the patient have a more desirable clotting time by helping restore healthy circulatory function? The answers to these questions would certainly not be a deficiency of warfarin, i.e., taking a sledgehammer to platelets. It could be a common elderly nutritional deficiency, such as DHA omega 3 oil or magnesium. Heaven forbid if a physician were to give dietary supplements instead of rat poison. Not only are both supplements known to help atrial fibrillation and stroke risk, they actually help bones and arteries and have no adverse effects. Maybe doctors could get past Health 101 and realize the cell membranes of platelets and other cells in the circulation are inherently flexible and do not stick together inappropriately when they are properly nourished, and need to stick together in certain situations. Numerous dietary supplements that promote cell membrane health, reduce inflammation, and/or enhance toxin clearance could be of immense help in these situations. All we need do is look at the elderly in Italy who followed the Mediterranean diet for the course of their lives. They live to an older age than Americans. They have a much higher quality of health in the last quarter of their life than Americans. They are poorer, have very little medical intervention and drug use, yet live longer. What they do have is a fresh and mostly organic food supply. Cleaning up the diet and removing irritants by eating an organic diet would do wonders for removing irritants from the circulation that make platelets stick together. The poor quality of our food supply is another area of betrayal of the public trust by the FDA, which now allows Frankenfood genetic mutations of real food to be sold as “food.” Managing stress is also very important. There are many options. Doctors would actually have to spend time getting to know the patient. Yes – it is far easier and more cost effective for physicians to measure clotting times and never talk to the patient for any length of time. So what if the patient dies – they are old and are going to die anyway (a prevalent attitude in elderly health care). There are plenty more guinea pigs standing in line. Our medical care system is sick, especially in the fear mongering and negligent treatment of our elderly citizens. MDiety syndrome is a disease worse than cancer. These physicians don’t have 1/100th of the wisdom of the people they are treating. There is no respect and dignity in our health system. What is the FDA Doing about This? Essentially – nothing. And now they have admitted they are a failure and are not able to protect the public from drug dangers. The FDA knows about the problems warfarin is causing. Is the FDA making sure there are proper warnings on the drug to make sure patients are informed of all the known risks? – no. Is the FDA demanding further post-marketing studies relating to the explosion of hemorrhage stroke consistent with the increase in warfarin use, especially in the elderly population? – no. Instead, the FDA sees the warfarin problem as a business opportunity for the new drug and biotech industry branch of its operation known as the Reagan-Udall Foundation for the FDA – otherwise known as FDA, Inc. The only label change to warfarin that the FDA has proposed will require a $300 - $500 test of genes, profits that go into the pockets of von Eschenbach-friendly companies and forward the idea that genetic testing is essential for health (a fallacy). Never before has there been a more massive conflict of interest. The FDA will now market and license the drugs it is supposed to be regulating for safety, as well as put out testing requirements to prop up the new industry it is in charge of. As payback to Orin Hatch (R-UT) for helping to turn the FDA into a quasi-drug company this past year (the most sweeping FDA change in 50 years) and being a huge backer of the permanent appointment of Andrew von Eschenbach to head the FDA, the University of Utah was awarded an FDA no-bid contract to do biomarker research using advanced genomics to determine which patients are most at risk for bleeding from warfarin. This is what I mean by a pie-in-the-sky Andrew von Eschenbach project. It exists not to really help anyone, but to forward his personal agenda of evolving new tools that can be used in the cancer industry – lining the pockets of his many friends in the biotech industry. Raising more money for this agenda is the only reason von Eschenbach is sending out a panic message about the FDA’s inability to protect the public. Fear is a great motivator. The warfarin project is simply a test project to expand an entirely new field of science that will be used in the cancer-for-profit industry. In ten years it might produce a set of very expensive tools to use in a doctor’s office for gauging warfarin toxicity differences amongst various patients – maybe. It is highly questionable that such research will yield better genetic tests than those that are already available and not widely used (due to cost and lack of proof). Sure it is important to forward scientific research. However, what about all the people dying from hemorrhage stroke and going to the emergency room because physicians are massively over-prescribing a dangerous drug that is basically only really good at producing repeat office visits and profits for Big Pharma?
The von Eschenbach warfarin project is a stupid waste of millions of taxpayer dollars – money the inept FDA is apparently already short on. Warfarin is toxic – period. It is a poison – period. It may be appropriate for some, but it is clearly over-prescribed in a patient population of poorly managed health. There are much better ways to naturally help people that the FDA is actively suppressing. This is all about profits for doctors, biotech companies, gene-experimenting food companies, drug companies, and preserving the vested interests behind a poor quality food supply AT THE EXPENSE OF HUMAN HEALTH. Beware of those using fear mongering to market their wares, whether it is happening in a doctor’s office visit or coming from the head of the FDA. FDA management is corrupt and negligent of their responsibilities – a price that is being paid for in lost and damaged health by the citizens of this country.
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In an unprecedented change of posture the New England Journal of Medicine has reversed itself on the issue of whether Vytorin causes cancer. In the initial release of data back in July NEJM stood by Merck and Schering-Plough, who hired an Oxford consultant to rule that a 50% statistically significant increased risk of cancer was by chance. I pointed out in an earlier posting that such statistical manipulation, based primarily on the opinion of the Oxford reviewer, was ridiculous. NEJM has had a sudden change of heart and now agrees with me.
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.
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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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