The Politics Of Health: Feature ArticleFDA Chief in Very Hot Water with CongressThursday, February 14, 2008Byron Richards, CCN 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. The FDA is now ignoring Congressional subpoenas of its records, setting up another showdown between Congress and the Bush Administration. Unlike former showdowns, national security is not involved. Will the Bush administration offer protection for a situation that involves needless deaths to Americans? The Chinese sentenced to death the head of their FDA for far lesser misdoings. The issue revolves around the fraud-riddled antibiotic Ketek which is made by Aventis, now Paris-based Sanofi-Aventis. Sen. Charles Grassley, R-IA, has been holding the FDA’s feet to the coals on the Ketek issue for the past several years ever since an 18 year old boy from Iowa was killed by the antibiotic when being treated for a routine infection. There are other deaths and many cases of liver failure. The House Oversight and Investigations Subcommittee has been looking into the matter since early last year, shortly after von Eschenbach’s permanent appointment to head the FDA. The available evidence paints a picture of the FDA turning this deadly drug loose on children even though it knew of safety problems, a trail of evidence von Eschenbach has actively covered up. In the face of Congressional scrutiny the FDA has since scaled back it’s approved use of Ketek, but has left it on the market to treat pneumonia. The FDA blames Aventis for the problems, who is also in hot water with Congress. The FDA is refusing to hand over records showing what it knew and when. Insider information indicates significant FDA wrongdoing. We already know that a clinical trial involving the drug was forged by a weight loss clinic in Gadsden, Alabama. The physician in charge, Dr. Maria Anne Kirkman-Campbell, is now serving five years in prison. Congress has been trying to get to the bottom of the matter, seeking to establish what Sanofi-Aventis and the FDA knew. Congress has hit a stone wall. It appears they both knew plenty – and covered their tracks. The House Subpoenas FDA Records Congress finally had enough. On January 25, 2008 John Dingell and Bart Stupak of the House Oversight and Investigations Subcommittee sent a memorandum stating they intended to subpoena FDA investigators, a private contractor, and various FDA records, which they followed through on several days later.
On February 12, 2008 the House committee held hearings on the matter. Douglas Loveland, a special agent at the FDA’s criminal-investigation office, told the committee that Aventis should have known there was fraud and there was a “catastrophic failure” of their clinical trial systems. They ignored “red flags” about the bogus data, “they were loud signals…they were bright signals.”
Last March von Eschenbach provided written testimony to the committee on events surrounding the Ketek drug approval. The committee subsequently learned from an FDA insider and those familiar with the approval that the testimony was not truthful. The committee had recently subpoenaed the FDA records regarding the preparation of this testimony to learn why it was lied to. On February 12, 2008 the committee was told by the parent of the FDA, the Health and Human Services Department, that these documents would not be provided because “The department has serious concerns about providing the kind of materials the committee has subpoenaed…such highly confidential and deliberative materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business.” A more skeptical outsider like myself would interpret this to mean “that when people are killed the FDA is above the law and doesn’t need to disclose relevant information.” Dingell is not taking the matter lying down: “What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there statements embarrassing to the administration?” He went on to say that “Neither Chairman Stupak nor I will tolerate such a perversion of Congressional powers to investigate and probe.” His next step to get the von Eschenbach records may be to hold Michael Leavitt, the HHS Secretary, in contempt of Congress – setting up a major showdown with the Bush Administration. FDA Whistleblower Dr. David Ross served as the FDA’s primary safety reviewer on Ketek. He was concerned about liver damage as early as 2000 and was stunned by the fact that the U.S. clinical trial contained blatant fraud. Back in 2003 he wanted to give this information to the FDA advisory panel that was deciding if Ketek was safe to use for the public. FDA management prevented him from doing so and purposefully withheld information from the advisory panel about the ongoing criminal investigation. Ross buckled to FDA management pressure and omitted the safety risks and his concerns about Ketek from his final report. This all happened prior to von Eschenbach coming to the FDA. Under von Eschenbach’s tenure as temporary head of the FDA the Ketek problems began to hit the fan. Congress started actively looking into the matter and von Eschenbach went into damage control mode. He called a meeting of 40 FDA employees regarding Ketek issues and mysteriously Ross was invited to this meeting (he no longer worked on the Ketek issue). Ross has reported that during the meeting von Eschenbach likened the workings of the FDA to a football locker room, where differing views can be vented but that once on the field the team speaks with one voice and any FDA staff who speaks differently will be warned the first time, benched the second time, and traded the third time. In the face of such a blatant effort to suppress the truth of the situation Ross turned whistleblower. He has told Congress that the FDA approved Ketek “despite knowing that it could kill people from liver damage and that tens of millions of people would be exposed to it.” Grassley Predicted the Unethical Behavior of von Eschenbach Back in February of 2007 Senator Grassley informed the House committee of the extensive nature of the FDA cover-up on Ketek as well as other issues, including FDA disregard for Congressional investigation. Von Eschenbach is a cancer-industry insider who took the job at the FDA so he could get quick approval of new biotech drugs while using humans for cruel experiments in the name of “progress.” His nomination as permanent head of the FDA took place during the 2006 lame duck session of Congress and was rubber stamped by Big Pharma friendly Senators. Senator Grassley knew better, as he stated on the floor of the Senate during the confirmation hearings: “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.” As Grassley’s warning fell on deaf ears, Orrin Hatch (R-UT), a man whose pockets are lined with Big Pharma money, rose in defense of von Eschenbach: “To me it is simply unconscionable that the Food and Drug Administration, one of the best little agencies in Government, has gone leaderless for such a period of time…I know Dr. von Eschenbach well. He is a man of integrity….I urge my colleagues--no, I implore my colleagues--to do what is right and vote [for] this nomination….it is what the American people deserve.”
Indeed, as history notes, the American people got von Eschenbach – a drug company sales rep sitting in the hot seat atop the dysfunctional FDA, an organization of unelected bureaucrats who are certain they are above the rule of law and certain they have nice jobs waiting for them in the Big Pharma world.
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The shocking death of Tim Russert last Friday has left an entire nation wondering what happened. He was a model patient, doing everything his doctors asked. All major media have run articles trying to explain the nuances and difficulties in treating coronary artery disease. These articles find little fault in Russert’s care, trying to create the idea that his heart attack was just too hard to predict and that all that could have been done for him was done. I beg to differ. His death represents the failure of standard medical care to produce a positive result – an occurrence that is all too common in today’s world.
Legions of well wishers look on as Senator Ted Kennedy struggles for his life, fighting against one of the most difficult types of brain tumors. Ironically, it may be the drugs he has so adamantly promoted that are the straw that broke the camel’s back, leading to his brain tumor.
The latest stone thrown at the 200-billion-dollar-a-year cell phone industry came from a study by neurosurgeon Vini G. Khurana entitled Mobile Phone-Brain Tumour: Public Health Advisory. His meta-analysis of existing cell phone studies may not contain a lot of new information; but his rather alarming message was carried by media around the world: “there is a growing body of statistically significant evidence for a relationship between the overall length of use of a mobile phone and the delayed occurrence of a brain tumor on the same side of the head as the ‘preferred side’ for mobile phone usage.” He claimed a 2-4 fold increased risk following 10 years of regular use.
On April 2, 2008 CNN spent the day bringing awareness to the problem of autism. Larry King’s segment, which included Jenny McCarthy along with a panel of guests, was particularly enlightening. My hat is off to Jenny, a celebrity mother who is making it quite uncomfortable for the Center for Disease Control (CDC) to ignore parents of autistic children seeking answers. Why does a mom have to do the work of the CDC? The answer is rather simple: our government’s zeal to insist on too many vaccines while ignoring the actual risks is the driving force behind the autism tragedy.
The Senate is about to approve legislation (Mothers Act – S.1375) which mandates the indoctrination of pregnant and nursing mothers into the use of extremely dangerous psychiatric medication. We already know this class of medication poses serious health risks to both mother and baby. Consequences to the baby are now proven to cause nerve-related changes that can adversely affect health for a lifetime.
Immediate Consumer Action is Needed to Stop Mothers Act The Mothers Act is pending legislation that will indoctrinate hundreds of thousands of mothers into taking dangerous psych drugs. It is a great example of how the Big Pharma lobby controls Congress to the detriment of health, as well as needlessly and dramatically inflating the costs of our health care system for everyone. Like any piece of legislation it purports to address a troubling issue – in this case the mood distress of mothers following birth known as postpartum depression. It is true that 10% - 15% of women need some assistance in dealing with this topic – but the majority of them sure don’t need it from Big Pharma. That is the Big Lie.
It now appears that the FDA Chief Andrew von Eschenbach, M.D. has committed perjury before Congress. Unlike Roger Clemens, who also seems to be putting his foot in his mouth before Congress, von Eschenbach’s actions appeared to have allowed unnecessary deaths to Americans – hardly the mission of the FDA. By contrast, Roger Clemens is simply causing death to his own reputation. Hopefully Congress can quit wasting taxpayer money on baseball and get to the bottom of what is really going on at the FDA.
Several high profile human cardiovascular drug experiments have turned into disasters for Big Pharma. These findings are sure to shake the misguided consumer confidence in drugs as a mainstay of preventive cardiovascular health. Hanging in the balance are billions of dollars of fraudulent drug sales based on the flimsy argument that changing numbers (blood sugar, cholesterol, or blood pressure) with the use of toxic drugs is somehow the same as actually being healthy…
Women across the country are being duped to consume billions of dollars worth of bone poisons under the false pretense that if they take them long enough they will not develop osteoporosis. Even the FDA is becoming alarmed by the side effects of these bone drugs. The biggest selling drug in this class is called Fosamax, made by Merck – the very same company that killed thousands of Americans with Vioxx while hiding cardiovascular risks from the FDA and patients. Does anyone trust them?…
Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media this month: “Statins Found to Turn On Gene that Causes Muscle Damage.” It’s now a fact of science; a new study shows that taking statins destroys your muscle to a greater or lesser degree. And let’s not forget that the heart is a muscle.
On November 29, 2007 the FDA made a rather surprising, almost honest announcement. It said that it could not protect Americans from the dangers of drugs. A 56-page report by its Subcommittee on Science and Technology stated the FDA “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” This blistering report on the life-threatening shortcomings of the FDA was released with the stamp of approval of the head of the FDA, Commissioner Andrew von Eschenbach. The flagrant disregard for human health by the FDA…
Oprah has done an immense favor to millions of American women by helping them understand that a malfunctioning thyroid gland may indeed be part of their weight and health problems. After writing openly about her thyroid problem in the October 2007 Oprah Magazine, she then went into the nature of thyroid problems on her TV show.
The United States Health Freedom Assembly met October 12 – 14, 2007 at the William Mitchell College of Law in Saint Paul, MN, a gathering of many of the top state, federal, and international health freedom advocates, organizations, and industry. The meeting took on a tone of extreme importance as the FDA has issued policy and obtained broad new regulatory authority over health freedom in the past 12 months. The FDA is seeking to undermine the law known as DSHEA (Dietary Supplement Health and Education Act of 1994), the cornerstone of health freedom in America. Emboldened by its new powers the FDA is now poised to trample the first amendment rights of companies and Americans who seek to explain or understand how nutrition can support health. The FDA campaign has begun.
On Wednesday, July 11, 2007 the House passed HR.2900 without allowing the Ron Paul (R-TX) amendments to protect dietary supplements. Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company.
The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, “We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”
Under the false pretense of improved food and drug safety the FDA is re-inventing itself as a kingpin drug company. This charade has so far hoodwinked virtually all members of Congress. The Senate has already approved this FDA transformation. The House will bring similar legislation out of committee next week, with a vote in the full House likely in July.
The Andrew von Eschenbach FDA era is upon us. The Avandia scandal is the tip of the iceberg. Is anyone ready? The words “illicit financial collusion” have been replaced by the politically correct term, “collaboration.”
The penalty in China is death, in America its business as usual. Zheng Xiaoyu, the former head of China’s FDA, was sentenced to death for accepting $832,000 in drug company bribes and for dereliction of duty. Like China, our country is in the middle of a drug and food safety crisis. Why is FDA Commissioner Andrew von Eschenbach, M.D. getting a free pass? Why did the Senate just pass legislation (S.1082) that gives von Eschenbach significantly more power to do whatever he pleases? And exactly what is it that von Eschenbach is doing?
Senate Attempts Damage Control – House Braces for Onslaught Senators were taken off guard by the public outrage over the passing of bill S.1082 with language that can be used to seriously harass dietary supplements by enabling the FDA to apply drug-related risk analysis to the safety of food and food ingredients (and thus dietary supplements).
The FDA is Acquiring New Powers to Suppress Alternative Health Your right to have free access to safe and highly effective dietary supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the Supreme Court sided with the FDA by deciding not to hear the case of Nutraceutical v FDA, letting stand a federal appeals court ruling that permits the FDA to use drug-related risk/ benefit analysis to determine if a nutrient is safe.
The Senate has sold out the American people. Anyone voting for change in the last election can now plainly see the shenanigans of a Democratic-controlled Senate. Under Republicans no FDA reform ever took place. Big Pharma owns so many Republicans that all meaningful legislation to curtail the deaths and injuries of American citizens at the hands of Big Pharma and the FDA had been completely thwarted for the past six years. Under Democratic control sweeping FDA reform favorable to Big Pharma was proposed and the majority of meaningful reform was blocked or seriously watered down. Which is worse? As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an “elaborate scheme.”
For approximately four days Americans lived in a delusional state that they may soon pay drug prices the same as every other country in the civilized world. Euphoria over breaking the Big Pharma monopoly turned to disgust as the chameleon, Senator Edward Kennedy (D-MA), changed sides and lead a contingency of Democrats against fellow Democrats lead by Byron Dorgan (D-ND). By passing the Cochran amendment the Dorgan amendment is poisoned and will no longer be effective. Maybe Democrats are now learning what Republicans have known for some time – you can’t trust Kennedy.
In May of 2006, after months of research and investigation, I published my ominous findings in the book Fight for Your Health: Exposing the FDA’s Betrayal of America. Everything I predicted in this book is on the fast track to becoming reality. A majority of Americans, not informed on current events and unaware of the history involved, are silent. Mainstream media, one of Big Pharma’s largest clients, is silent. Only the power of the internet, which rivals the invention of the printing press in significance, is making it possible for individuals to understand what is going on.
There is still time to stop FDA, Inc. Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is known all over Capital Hill as Big Pharma-designed legislation. It is running into all sorts of credibility problems. A vote is likely on Monday – delayed due to all the opposition flooding the Senate by “we the people.”
S1082 Update – Tuesday’s Activity. Fight Erupts on Senate floor: As the Senate continues to debate the Big Pharma-friendly sweeping reform of the FDA a new problem for Big Pharma’s prize Senators has erupted and quickly turned into confrontation on the floor of the Senate. At stake is at least 10 billion dollars per year in exorbitant Big Pharma profits. In one corner is Big Pharma-puppet Orrin Hatch (R-UT), representing the Kennedy/Enzi drug cartel. In the other corner is a majority of Senators lead by Byron Dorgan (D-ND).
The combination of a lack of sun and cold weather invariably strains your mood as well as your metabolism. It is an energy-depleting form of stress, similar to having a daily argument with someone. If your energy systems…
S1082 Update – Monday’s Activity at the bottom of this article. Bill S1082: The Food and Drug Administration Revitalization Act (also called the Prescription Drug User Fee Act of 2007) is one of the greatest scams and con jobs ever foisted on the American public. Current FDA management is grossly incompetent on the subject of drug safety.
A new attack against health freedom, drug safety, and dietary supplements was launched last week by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY). It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA’s dysfunctional management and legal team – meaning this legislation was written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.
Americans are up in arms that our pets are being injured and killed by a toxin sent to America by a Chinese company. Melamine, a toxic fertilizer used in China, is the suspected culprit behind the deaths and injuries to potentially hundreds of thousands of our pets. The FDA assures us that this toxin has not entered the human food supply – does anyone believe in the competence of the FDA? It is only a matter of time before this type of problem happens to humans, as the inept FDA has no control over imported food intended for humans, let alone pets.
On February 13, 2007 the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations opened hearings lambasting the FDA regarding the safety of drugs. The opening statement by Chairman John Dingell (D-MI) set the tone, “It is clear … that the FDA is badly broken. I expect that before we finish this investigation, which is just getting underway, we will discover whether the problems we have found are due to the work of scoundrels, irrational penny-pinching, or because the doors to the FDA “hen house” have been thrown open to foxes. It may be a combination of all three.”
Wall Street, international bankers, President Bush, pharmaceutical companies, new biotech companies, the Rockefeller empire, and the FDA have created a new plan for public health. It is a grand vision based on profit. It will use the FDA and, as needed, the Department of Homeland Security as the regulatory police force that ensures compliance in the name of public safety. Legitimate objections may be overpowered in the name of national security.
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