The Politics Of Health: Feature ArticleThe FDA: An Agency Out Of Control - Part 1 of 2Friday, February 09, 2007Byron Richards, CCN The FDA is steamrolling its way to a grand vision of repressive health care based on profits for Big Pharma and new biotech companies at the expense of human health.
A current case in point is the heart bypass drug, Trasylol, a medication often given so patients don’t bleed too much during surgery. A study published in the February 7, 2007 issue of the Journal of the American Medical Association showed that Trasylol was found to significantly increase the risk of death in the subsequent five-year period following heart bypass surgery. The data predicts that for the 246,000 Americans receiving this drug in 2005, over 19,000 will needlessly die in the following five-year period. FDA warnings in early 2006, weak as they were, curtailed the blockbuster growth of the drug, and it appears the drug lost about 20% of its sales compared to 2005. This means that roughly 15,000 Americans receiving Trasylol in 2006 will needlessly die over the next five years because the FDA twiddled its thumbs to protect Bayer from an avalanche of lawsuits, even while Bayer lied point blank to the FDA (the Justice Department should be investigating). You heard me correctly, the head of the FDA, Andrew von Eschenbach, made an administrative decision to leave Trasylol on the market to protect Bayer, brushing aside a blatant Bayer cover-up. Of course, the problem is ongoing in 2007, exposing innocent Americans to unnecessary risk that is likely to result in an additional 1000 deaths per month (over the next five-year period). Bayer was expecting Trasylol to be its next blockbuster drug and was in Phase III trials to use the drug for all kinds of common operations (these trials were dropped in January 2007). While Bayer made $291 million on the drug in 2005, the drug generated over 1.2 billion in treatment fees for the friends of Bayer due to all of its damaging side effects. This information was published in a January 2006 article in the New England Journal of Medicine. The study showed that Trasylol doubles the risk for kidney damage, causes 10,000 patients per year to require dialysis for life, increases heart attack risk by 48%, increases heart failure risk by 109%, and increases the risk of stroke by 181%. I mean really, what would you expect from a drug that promotes clotting in someone with clogged arteries??? Thus, since at least January of 2006 the FDA has had the data, heart surgeons have had the data, and Bayer executives have had the data. At what point does criminal neglect enter in to the picture? Following this information Bayer did its own independent study, hid the results from the FDA because they were so bad, and lied to an FDA advisory panel telling it that Trasylol was safe (see link in previous paragraph). Yet, von Eschenbach still didn’t take the drug off the market. Trasylol has been on the market since 1993 with about 4 million users worldwide. Based on the statistical evidence in the new study, this translates to about 320,000 unnecessary deaths around the globe (almost half are Americans). What punishment is there for German executives who kill Americans? And what about the doctors who are well aware of Trasylol risks and use it anyway (never informing the patient)? What motivates them? How much is Bayer paying them in perks to use the drug? The Justice Department should be investigating. There are older drugs that are 1% to 4% of the cost of Trasylol, work by a different mechanism, don’t kill people, and don’t generate the additional billion or more in treatment costs each year. Andrew von Eschenbach, as head of the FDA, has some serious explaining to do. Yes, this is the same Andrew von Eschenbach that was permanently appointed head of the FDA by the Senate in the lame duck session of Congress. Both sides of the aisle sold out American citizens (see how your senators voted), allowing the von Eschenbach appointment to go through (paid for by the Big Pharma lobby). The only Senator with any significant fortitude and honor was Charles Grassley (R-IA), whose Senate confirmation testimony regarding Andrew von Eschenbach on December 7, 2006 was accurate, frank, and to the point: “People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.…This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people…Under Dr. Von Eschenbach, the FDA has not only avoided transparency, it also has threatened those who are trying to desperately expose the truth….” America has huge problems with health care and the quality of care. Big Pharma owns both political parties and the White House. Big Pharma owns the FDA. The head of the FDA is now a Big Pharma biotech sales rep. Big Pharma owns the American Medical Association. Big Pharma sponsors numerous “scientific” journals as well as funds the research they publish. Big Pharma owns the researchers in many academic institutions. Big Pharma owns the pen and pencil of almost every doctor in America. Big Pharma owns the mainstream media, and will use it to downplay problems and openly attack dietary supplements (their only real competition). The FDA is headed on a path of becoming a full fledged drug company. Big Pharma is stealing the profits of corporate America and the wealth of American citizens through the creation of a sickness industry paid for by corporations and taxpayers, and fully sanctioned by the federal government. Yet, the American public is unable to act while Rome burns. It is truly a sad state of affairs, rotting away the very pillars of our democracy. In order to have any faith in the human spirit I need to take the view that the American public is simply uneducated and that ignorance is bliss, from the point of view of Big Pharma. All I can do is try to inform. To do so I am taking the rather unusual step of publishing my expose book, Fight for Your Health: Exposing the FDA’s Betrayal of America, on NewsWithViews.com. Each week I will release a chapter or two, along with a few brief comments as to the current situation with any topics discussed in the chapter. If enough people actually comprehend what is going on we may be able to rise above the rather significant problems that challenge our nation. This is a gift; please pass it along to your friends.
Here is what you can do: e-mail me () your personal story of drug-induced side effects (yourself or a family member). I am particularly interested in stories about ADHD drugs, antipsychotic drugs, bone drugs, statin drugs, and blood pressure drugs – although any story is fine. Please keep stories to 250 words, include your name and mailing address, and whether it is OK to publish your name. Each week I will publish some of the stories following my chapter. If I use your story I will send you a free autographed copy of Fight for Your Health. If enough Americans read the experiences of other citizens it may help break through the “collective numbness” that has been induced by the bombardment and reporting of war-related death and injuries on TV and in the media.
THIS IS A STORY ABOUT HEALTH. It is not your typical health story; it is the real story of how your health and the health of your children are being seriously compromised.
The real story shows that the FDA has spent the last hundred years boosting the profits of drug companies and eliminating competition to those companies, acting as a misguided police force that has little to do with public safety. The trend has progressively worsened over the hundred-year period and reached a new low in 1992, when President William Jefferson Clinton allowed the FDA to accept millions of dollars in drug company money to help approve drugs, a practice that continues to this day. The problems worsened in recent years, as President George W. Bush actually turned portions of the FDA itself into a drug company, responding primarily to the interests of Wall Street. He installed a new FDA chief and second-in-command who have multiple connections to drug companies and Wall Street (Andrew von Eschenbach, M.D., and Scott Gottlieb, M.D.). Public safety is low on the list. Citizens’ rights are low on the list. Rushing new and expensive unproven drugs onto the market is now a top priority. Of course, stamping out competition remains an important duty.
The quality and safety of health care are major concerns for Americans, especially regarding our children. Consumers actively look for the best options to maintain their health. Our society uses a combination of traditional medical and alternative approaches in an effort to harness the best of both worlds. This is all about to change; there is a new vision for American public health. It is a plan sponsored and promoted by the Bush administration, the FDA, and drug companies. It is based on the new politics of the emerging global economy, at the expense of personal health freedom. For part 2 click below.
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.
|
| Home > Health News > The Politics Of Health: Feature Article |
