Resolving The Worsening
Crisis At The FDA


The FDA has been taken over by the very industries that it was meant to regulate. This is outrageous; this is tragic; at times, this is even criminal. The unholy alliance between corporation and state have bled out even the pretense that the FDA is working for the benefit and safety of the American people. The FDA is a failed bureaucracy under corporate control. This sad litany affects every single American, and is compellingly detailed in this article by Stephen Fox. His analyses are at times horrifying, yet are always medically and legally accurate; his recommendations concerning corrections, especially at the state (rather than Federal level) are insightful.
KP Stoller, MD
President, International Hyperbaric Medical Assoc
Medical Director, Hyperbaric Medical Center of New Mexico
By Stephen Fox
Never before in Human History has food chemistry been so precarious and so critical to the health of billions. This results from multinational corporate biochemical mayhem going unchecked by regulatory bodies in every nation, the worst two being the United States Food and Drug Administration and Chinas total lack of standards. This crisis is worsening, demonstrated by the FDA failing to discern the imported melamine from China in the wheat and rice gluten additive to pet food that has already killed at least 4000 pets, and the failure to prevent imports of diethylene glycol, the fake glycerine from China added to medications as a sweetener, which has killed hundreds, especially children, from Panama to India to Bangladesh.
These egregious vignettes, however, pale in epidemiological comparison with harm done by the manufacturing of neurotoxic and carcinogenic food additives in general, which is rapidly destroying health in hundreds of nations. My own theory is that melamine, not normally very toxic, became poisonous when mixed with cyanuric acid in the bottom of the vats in China, a theory also advanced by Richard Goldstein at the Cornell College of Veterinary Medicine.
Food-flavoring workers in California were recently diagnosed with bronchiolitis obliterans, a rare and life-threatening form of lung disease, also known as popcorn workers lung, particularly in workers at microwave- popcorn factories; the disease destroys the lungs. Since 2001, studies have shown links between the disease and a chemical used in artificial butter flavor called diacetyl. Flavoring manufacturers have paid out more than $100 million as a result of lawsuits by people sick with popcorn workers lung over the past five years. One death from the disease has been confirmed among workers; how many have gone undetected in the general population?
Lawsuits against Pfizer and Zoloft have resulted in the FDA recently requiring antidepressant manufacturers to add suicide warnings to their products, a belated public relations gesture. Even the normally unflappable Dr. Andrew Von Eschenbach, Commissioner of the United States Food and Drug Administration, was very recently appointed a new Assistant Commissioner for Food Safety and Security, Dr. David Acheson, M.D. A 1980 graduate of University of London Medical School, Acheson trained in internal medicine and infectious diseases then taught at Tufts Medical Center and researched food borne pathogens, focusing on Shiga toxin- producing E. coli. He also participated in FDA discussions about the fact that heating french fries to 425 degrees transforms the starch into the carcinogenic acrylamide. (In 2003 and 2004, then Attorney General of California Lockyer tried to officially label french fries as containing a chemical known to the State of California to cause cancer, over the objections of the fast food lobby and the FDA commission at that time. Perhaps the present AG of California, Jerry Brown will continue this vital consumer protection battle).
Rep. Rosa DeLauro, Connecticut Democrat and senior member of the House Appropriations Committee, blasted Achesons appointment as a mere "reshuffling of management" doing little to prevent future outbreaks. "The agency should have a sense of the barriers, gaps and most critical needs in our food safety system," DeLauro said. "What is needed to adequately protect our food supply is strong enforcement authority that would require mandatory recalls of contaminated products and a commitment from agency management to follow-through with safety investigations."
This pet food thing has shown people, including people at the very highest levels of the administration, that something needs to be fixed. If this isnt a wake-up call, the people are so asleep they are catatonic, stated William Hubbard, Associate Director of FDA from 1991 to 2005. As long as the system depends on government inspectors to detect problems and pull dangerous foods, its a failed system, said Michael Taylor former Director of the Agriculture Departments Food Safety Service. Former FDA Commissioner David Kessler, who served under both Bush I and Clinton, maintained that major improvements were needed from Congress, the industry and the FDA."The food safety system in this country is broken," Kessler told the Oversight and Government Reform Committee. Kessler said the FDA needed more money for food safety efforts and should make it a higher priority. "Food safety can't be delegated to second-tier management within the agency, and the fact is that food is a second-tier priority within the FDA," Kessler said.
More money for more experts? Was Kessler joking? We wantonly add chemicals to almost everything we consume as food, almost none of which existed 101 years ago when the Pure Food and Drugs Act was passed, the precursor of the 1937 FDCA that created the FDA (except for Saccharin from Monsanto, invented in 1904). Ralph Nader published THE CHEMICAL FEAST in 1970. Everything is done for superficial appearance or taste. Sodium hexametaphosphate added to potatoes. Sodium Erythorbate, Sodium Nitrates and Nitrites TBHQ, BHA, and BHT, some of which chemical relatives of embalming fluid routinely added to meats and manufactured food products, result in cancers from heated carcinogenic nitrosamines. Artificial sweeteners, made by adding chlorine to sugar (Sucralose/Splenda) or Aspartame, metabolized as methanol and formaldehyde. Take coffee beans; add mercurial fungicides during the transport, then mix the coffee with chemicals like artificial sweeteners and non-dairy creamers, or even just the regular old recombinant bovine grown hormones, found in 99% of the USAs milk, all at higher temperatures which release the proven brain tumor causing diketopiperazine from the Aspartame molecule. Ship cases and cases of Diet Sodas to the Middle East, store them out in the sun at 120 degrees, and then are you surprised when the troops drinking 12-15 daily of these come home with neurological impairments conveniently dubbed Gulf War Syndrome, as if someone else were responsible for these Weapons of Mass Destruction?
Are you surprised when children drinking sodas for breakfast and having manufactured junk food at lunch doled out in the federally funded school lunch programs develop behavioral problems like the Attention Deficit Hyperactivity Syndrome, or worse genetic afflictions like Autism? Or when they fail academically or develop criminal pathologies at an early age, and they develop Adult Onset Diabetes at the age of 10 or 11? Add in pesticides, herbicides, fluorine and chlorine in the water, and unburnt hydrocarbons and carbon monoxide in the air, and you have a witches brew of toxic chemicals that is destroying health in the USA and other nations. When activists, lawyers, and legislators try to take some tiny incremental step to begin to correct even one of these problems, they are met with a solid wall of bureaucratic intransigence, corporate lobbyists, stonewalling, and idiotic denial of even the basic premises of their arguments, as if that to reveal that critics are paranoiac will somehow defuse their arguments.
At the level of the New Mexico Legislature 2005-2007, it became absurd to talk to State Senators about the obvious need to prevent Aspartame from harming our children, while six out of nine of them were obliviously guzzling their own can of Diet Coke! Only when bodies pile up killed by chemicals, as they did from DDT, Agent Orange, Asbestos, Vioxx, and others, will the corporate clamor and smoke and mirrors evaporate. Only when the massive lawsuits and judgments begin to roll up will regulatory authorities like the FDA be FORCED to rescind the approval for more of these harmful chemicals, and will see state-level FDAs created by legislatures.
Once, I had hope about FDA Commissioner Von Eschenbach, a cancer survivor who proclaimed that he sought to end cancer by 2015.However, in every single case wherein he was contacted by Aspartame victims, physicians treating Aspartame poisoning, citizen activists, and even state and national Senators, he has either ignored them or else diligently toed the line of cranking out corporate-pleasing lies. In his letter responding to 21 New Mexico legislators asking for Aspartames approval to be rescinded, Von Eschenbach said FDA has yet to be presented with credible scientific evidence! Fact: FDA has always completely ignored or discredited evidence laid before them (just google Ramazzini Oncology Foundation, Dr. Russell Blaylock, Dr. H.J. Roberts, Dr. Betty Martini, and others, to read some of the evidence).
I am suspicious of Dr. Acheson, the recently appointed Food Safety and Security Deputy Commissioner. At best, he is a band-aid pasted on to thus far unsolved afflictions, another gutless apparatchik appointed to appease our increasingly angry public, yet not rock the boat of the grander Administration schemes of corporate-driven Haliburton-corrupted plutocracies, health be damned. Acheson has thus far obtained the ringing endorsement of the Grocery Manufacturers of America, who lick his boots and count on him to do absolutely nothing to correct the medical, neurological, epidemiological, and educational harm done by the biochemical mayhem and chemical feast called mainstream American cuisine.
Hillary Clinton very recently called on FDA and the Agriculture Department to strengthen regulations for imported and domestic foods. In a letter to Secretary Mike Johanns of the USDA and to Commissioner Andrew Eschenbach, Clinton wrote that "On top of the direct threat to human health, this contamination also threatens our agricultural industries. It is unconscionable that America does not have proper mechanisms in place to adequately test and track food and feed materials from overseas." She asked: "What procedures you plan to put in place to test food and feed products coming in from overseas, especially countries with lax food safety standards? How you can improve the monitoring and tracking of products once they enter into the United States? How you will alert the public to these
problems in the future?"
However, as long as we have current and prior Presidents and the rest of the current Presidential candidates addicted to junk food, unable to recognize the neurological harm done by their own guzzling of aspartame in diet sodas, is there any political resolution possible to curtail general
fast food corporate abuses of human health? Please let me know what you think!
Stephen Fox
Founder, New Millennium Fine Art
US Senate Votes To Give FDA Sweeping New Powers
By Robert Pear
Washington Post
May 9, 2007
WASHINGTON -- By a vote of 93 to 1, the Senate passed a bill last Wednesday giving the FDA new power to police drug safety, order changes in drug labels, and restrict the use and distribution of medicines found to pose serious risks to consumers. The bill calls for a fundamental change in the philosophy and operations of the FDA, requiring the agency to focus on the entire life cycle of a drug, including the experience of patients who later take it. Senators said the bill was a response to a loss of confidence in FDAs ability to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004.
The Bush administration has not actively opposed the measure and many drug manufacturers support it. The bill is widely seen as "must pass" legislation because it renews authority for the government to collect fees from drug companies to speed the review of their products. "This legislation will make a major difference for families in America, ensuring the safety of our prescription drug system," said the chief sponsor of the bill, Senator Edward M. Kennedy, Democrat of Massachusetts. "We will also have safer food for families and for pets."Senator Michael B. Enzi, Republican of Wyoming, said the bill was the "most comprehensive drug safety overhaul in more than a decade." The no vote was cast by Senator Bernard Sanders, the Vermont independent who is an outspoken critic of the pharmaceutical industry.
The bill sidestepped a multibillion-dollar question: how to give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year. "If fines are nothing more than the cost of doing business, you cannot deter bad behavior," said Senator Charles E. Grassley, Republican of Iowa, who proposed the increase. Under the bill, the government would analyze data on tens of millions of patients, looking for signals that particular drugs posed serious risks.
To minimize those risks, the government could order changes in a drug's label and could require the manufacturer to conduct more studies and clinical trials of a drug already on the market. Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the FDA can request but not compel manufacturers to perform studies.
"For Vioxx, it took 14 months to change the drug's label to warn doctors and patients of the danger," Kennedy said. "Companies routinely promise to conduct studies that are never even started, much less completed." The bill would require the government to establish a public database of all clinical trials and their results. Senator Enzi said the bill could speed the approval of new drugs, by giving the FDA more tools to protect patients after treatments were approved. In exceptional cases, the FDA could restrict the use and distribution of a drug that posed extraordinary risks. The agency could, for example, require special training for doctors who prescribe a particular drug, certification of drugstores that dispense it and monitoring of patients who take it.
Information on aspartame:



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