CHINA HAS A SOLUTION FOR THE FDA's PROBLEM

The Next Vioxx

On June 6, 2007, Henry Waxman (D-CA), Chairman of the House Committee on Oversight and Government Reform will haul in Andrew von Eschenbach to testify on why the FDA failed to warn Americans of the extreme cardiovascular danger and increased risk of death from taking Avandia, a 3 billion-a-year blockbuster diabetes drug made by GlaxoSmithKline. Statistics that were primarily obtained from GlaxoSmithKline’s own research data predict that 35,000 people needlessly died taking Avandia last year and the FDA was fully aware of the risks and chose to ignore them. In fact, the problem only came to public view because one independent researcher pursued the investigation and published his findings in the New England Journal of Medicine. This is the FDA’s job, why do we need citizen watchdogs to do the work instead?

It is certain that during Von Eschenbach’s testimony he will speak out of both sides of his mouth and cover the FDA’s ineptitude and deceit. He is likely to blame a lack of FDA funding for the problems. In reality, the FDA is not at all as incompetent and under funded as they seem. The truth of the matter is that the FDA does exactly what they want. The FDA spends its time, energy, and money on management’s priorities.

It is hard for some to grasp that safety of drugs or safety of the food supply is not the top FDA management priority. In the case of Avandia Americans are being needlessly killed as a result of FDA management decisions. These decisions preserve the profits of drug companies and further the myth that drugs are the answer to our health problems. Do not be misled, FDA actions are intentional.

The timing couldn’t be worse for the FDA as Waxman is preparing the House version (HR.1561) of the recently passed Senate drug safety bill (S.1082). The Senate version is a fake safety bill paid for by Big Pharma. Will the House follow along or will they put some real teeth in the legislation?

How Does One Define Dereliction of Duty?

The dictionary defines it as a deliberate neglect of duty or obligations. Certainly, Avandia is a case in point. However, Avandia problems are the tip of the FDA iceberg. Anyone caring to look will find a rabbit hole so deep and so full of stench that it is virtually impossible to comprehend. The story is so bad that it falls into the category of not believable. Under the leadership of Andrew von Eschenbach collusion with the industries the FDA is supposed to regulate has reached an all time high. This reckless behavior has resulted in deaths and injuries to hundreds of thousands of Americans, all for the profit of drug companies at the expense of human health.

A case in point is the antibiotic Ketek, which the FDA approved for broad applications KNOWING it was going to injure children. Von Eschenbach even threatened FDA scientists who didn’t see the Ketek issue his way. Then there is the case of the atypical antipsychotic Zyprexa, which the FDA approved for use in adult schizophrenics even though the FDA knew the drug caused obesity and diabetes. The FDA sits around allowing billions of dollars of this drug (mostly at taxpayer expense) to be given to children for mild behavioral issues, an unapproved use that leads to extremely poor health and disease. Then there is the Trasylol scandal, a very expensive cardiovascular bypass drug that needlessly sentences 15,000 Americans per year to premature death within the next 5 years. When Bayer was caught directly lying to the FDA regarding Trasylol’s dangers, von Eschenbach deflected legal liability for Bayer by doing virtually nothing and leaving the drug on the market. These are just a few examples, there are unfortunately many more.

The common theme is that FDA management intentionally hides risks of drugs so that drug companies can turn them into blockbusters, oftentimes selling them in ways that were never approved in the first place. As chilling safety problems are reported to the FDA the organization fails to act, partly so it won’t look bad for approving the drugs in the first place, partly to preserve billions in profit for various companies, and partly because FDA management employees are often eyeing high-paying jobs in the industry that is being regulated. It is not that the FDA is incompetent. In fact, FDA scientists routinely warn management of the problems. Management intentionally does not act in a way that protects American consumers. In virtually all cases the economic situation of drug companies is placed ahead of human health and safety. In my way of looking at the world this is dereliction of duty.

This is as true of drugs as it is of our massively adulterated food supply (genetically modified foods, viral cocktails approved as food additives, chemicals allowed on food, chemicals allowed as flavoring agents or sweeteners, etc.). The FDA has no way to trace the toxicity of genetically modified food and actively prevents labels that would tell consumers they are even eating the garbage, which now permeates the packaged foods on grocery store shelves. At the same time the FDA actively works to suppress information about natural ways to improve health. All of these FDA actions are intentional.

China gives the death sentence for dereliction of duty. In America we conduct hearings (sometimes) and then do nothing. Big Pharma and Big Biotech own the FDA, the White House, and much of Congress.

The FDA’s Real Priority

Andrew von Eschenbach has never hidden his agenda; it is more an issue that people simply aren’t paying attention. The top priority of the FDA is now the von Eschenbach dream, which is to bring new biotech drugs to the market with far less safety or effectiveness testing and then conduct experiments on individuals as the drugs are used in clinical practice. This effort is called the Critical Path Initiative and it will take a giant step forward should the Reagan-Udall Foundation for the FDA come into existence as proposed in Senate bill S.1082. Von Eschenbach has stated that this is the very top priority of the FDA for many years to come (not food or drug safety).

Von Eschenbach is an oncologist who wants to create a cancer sickness industry wherein nobody is cured; they are simply managed indefinitely on super expensive medications. Von Eschenbach has led this effort for many years as a key figure in the elder Bush’s C-Change, a group facilitating the development of Big Biotech drugs for highly profitable cancer “treatment.”

Andrew von Eschenbach took the top job at the National Cancer Institute to forward this agenda. As its head he diverted billions of dollars of research funding into C-Change companies and away from fundamental cancer research, a shocking travesty. Even more appalling is that Tommy Thompson, then head of the Department of Health and Human Services, approved a waiver allowing von Eschenbach to remain on at C-Change while he headed the National Cancer Institute. This is one of the most dramatic conflicts of interest imaginable, setting back vital cancer research at least a decade.

Tommy Thompson, like so many government officials, has moved on and now helps Verichip sell implantable RFID chips. In October of 2006 Von Eschenbach was appointed to head the FDA, and for a while he held all three spots (C-Change, head of NCI, and head of FDA). In the recent Lame Duck session von Eschenbach was made permanent head of the FDA. No questions were asked of his extensive connections to the Biotech industry.

It should come as no surprise that von Eschenbach wants to make the FDA part of the drug development business, including licensing and marketing rights for the drugs the FDA helps develop with its sophisticated software. Is it possible to imagine a greater conflict of interest? We are not talking about a paltry $780,000 worth of conflict of interest, we are talking tens of billions. Do you think for a moment the FDA will ever remove one of its own drugs from the market or paint a clear picture of its true risks?

A Time for Action

Senate bill S.1082 and House bill HR.1561 will turn into some type of new and sweeping FDA “reform” before Big Pharma’s funding of the FDA expires on September 30 of this year. The big question is what will be in the legislation. So far, Big Pharma was able to buy enough Senator’s votes to neutralize any meaningful reform. The Avandia scandal is likely to make matters worse for the FDA as the House considers its version of this legislation after the Memorial Day recess.

Buried within this legislation is an FDA sneak attack on dietary supplements. Dietary supplements are routinely targeted by the FDA as they offer true competition, both safe and effective, to drugs. The FDA acts as a police-force bully to help stamp out Big Pharma competition and keep Americans in the dark on natural ways to prevent and treat disease. Bill S.1082 allows the FDA to apply drug-related risk benefit analysis to the safety of food and dietary supplements and remove commonly used products from the market at their whim. This must be stopped. A take action letter can be found by clicking here.

At least one hundred thousand people needlessly die per year at the hands of Big Pharma drugs. Several million are injured so seriously they have to go to the hospital – and unfortunately many are injured while at the hospital. The FDA actively and intentionally withholds from doctors and patients the true risk profile of many drugs despite the desperate warnings of its own safety scientists and independent experts. There is no question that FDA top management suffers serious dereliction of duty. Should we follow the lead of the Chinese? Maybe then drug safety and food safety would improve.

Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.

Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com

E-mail: byron@truthinwellness.com