FOOD AND DRUG REGULATION AFTER 75 YEARS BY ARTHUR HULL HAYES, JR., FDA COMMISSIONER WHO OVER-RULED THE BOARD OF INQUIRY AND GOT DEADLY ASPARTAME MARKETED - JAMA, 9/11/81

By Dr. Betty Martini, D.Hum.
Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097
Telephone: 770-242-2599
E-Mail: BettyM19@mindspring.com
Web Site: http://www.mpwhi.com



Posted: 05 July 2008


Dr. H. J. Roberts who wrote Aspartame Disease: An Ignored Epidemic, the 1000 page medical text dug up this article. http://www.sunsentpress.com We thank Lane Shore, Mission Possible Chicago for sending a good copy in a Word document.

Remember the FDA tried to have G. D. Searle indicted for fraud but both US Prosecutors hired on with the defense team and the statute of limitations expired. http://www.mpwhi.com/drug_testing_falsified.htm Then the FDA revoked the petition for approval. The next day Searle filed suit against the FDA. Donald Rumsfeld, then CEO of Searle, said he would call in his markers and get aspartame on the market anyway. What were those markers. President Reagan had told Rumsfeld he would nominate him for Vice President but instead he nominated Bush. Rumsfeld was on Reagan's transition team and he felt Reagan owed him a favor. Reagan paid off to the detriment of the health of the world. First Reagan had Mary Francis Wright of the Reagan transition team call Dr. Jere Goyan, FDA Commissioner who would have signed the revoked Board of Inquiry Report of the FDA into law, at 3:00 AM and fire him. Here is the letter from his wife confirming those facts: http://www.mpwhi.com/letter_about_jere_goyan.pdf The day after President Reagan took office he appointed Arthur Hull Hayes as FDA Commissioner to over-rule the Board of Inquiry. However, he knew it would take 30 days to get Hayes there and it would be too late. So he wrote an Executive Order making the FDA powerless to do anything about aspartame until Hayes got there.

All this is confirmed by Attorney James Turner in the movie Sweet Misery: A Poisoned World, http://www.soundandfury.tv Here is the clip "Meet Donald Rumsfeld": http://www.soundandfury.tv/pages/rumsfeld.html The Executive Order, incidentally, is by law suppose to be on file and yet has been stricken. I wrote the FDA a FOIA request and they have refused to release it.

Once Hayes got to the FDA it changed. No longer was FDA the adversary of Big Pharma. Here's a newspaper article that discusses this in detail called "The New FDA: Good Medicine for Drug Companies" - http://www.mpwhi.com/the_new_fda.htm Hayes over-ruled the Board of Inquiry and got aspartame marketed. What was his reward? He went to work on a ten year contract for Sidley & Austin, Searle's PR Firm, for $1.000 a day. What a reward. One article said he was never there except for about 15 days. You know what an FDA Commissioner does at a PR firm? Send postcards home from Bermuda!

Now here Hayes writes about the FDA and discloses what we know and what he knew at the time of approval. For one thing he mentions that food adulteration is a federal crime. Yet he had seen the protest of the National Soft Drink Association which is now in the congressional record and knew aspartame is adulterated. http://www.mpwhi.com/open_letter_dick_adamson.htm He discusses in this article that the law on adulteration which is mentioned in the protest above banned from interstate commerce any traffic in adulterated or misbranded food or drugs and made it unlawful to manufacture such products in the United States. So Hayes has over-ruled a Board of Inquiry that revoked the petition for approval of aspartame with full knowledge that this poison is adulterated and also violates Interstate Commerce laws. What gall. How blatant can you be? Hayes had full knowledge that aspartame violated the law.

Hayes also knew that aspartame violates the Delaney Amendment. The late FDA toxicologist, Dr. Adrian Gross exposed this later in congressional hearings and admitted FDA violated the law. It was violated by Arthur Hull Hayes!

On August 1, l985 the FDA's own toxicologist, Dr. Adrian Gross, told Congress at least one of Searle's studies "has established beyond ANY REASONABLE DOUBT that aspartame is capable of inducing brain tumors in experimental animals and that this predisposition of it is of extremely high significance. ... In view of these indications that the cancer causing potential of aspartame is a matter that had been established WAY BEYOND ANY REASONABLE DOUBT, one can ask: What is the reason for the apparent refusal by the FDA to invoke for this food additive the so-called Delaney Amendment to the Food, Drug and Cosmetic Act?"

The Delaney Amendment makes it illegal to allow any residues of cancer causing chemicals in foods. In his concluding testimony Gross asked, "Given the cancer causing potential of aspartame how would the FDA justify its position that it views a certain amount of aspartame as constituting an allowable daily intake or 'safe' level of it? Is that position in effect not equivalent to setting a 'tolerance' for this food additive and thus a violation of that law? And if the FDA itself elects to violate the law, who is left to protect the health of the public?" Congressional Record SID835:131 (August 1, l985)

Also note there is no safe dose of aspartame. Hayes discusses comprehensive legislation over the years. He mentions the addition of poisonous substances to foods was prohibited. What is aspartame but an addictive excitoneurotoxic carcinogenic drug - a deadly chemical poison. It was listed with the pentagon in an inventory of prospective biochemical warfare weapons submitted to Congress. (NutraPoison on http://www.dorway.com and The Ecologist: http://www.mpwhi.com/ecologist_september_2005.pdf) It is a chemical hypersensitization product and makes victims chemically hypersensitive for life.

Hayes knew aspartame was poison, that the FDA had tried to have the company indicted for fraud. They simply couldn't get this poison to show safety and they got caught. FDA Audit, Bressler Report: http://www.dorway.com/bressler.txt Later on 60 Minutes when Dr. John Olney made world news on the aspartame brain tumor issue, Dr. Ralph Walton exposed research on scientific peer reviewed studies and funding. Seems 92% of independent studies show the problems and if you eliminate 6 studies the FDA had something to do with since their conversion to Big Pharma's Washington Branch Office, betraying the public trust, and one pro-industry summary, 100% of independent studies show the problems. http://www.holisticmed.com/aspartame goes over industry severely "flawed" studies and explains how its done. For instance, here is scientific abuse in seizure research on aspartame: http://www.holisticmed.com/aspartame/abuse/seizures.html An epileptic organization has told us they did a study and it showed that aspartame not only triggers seizure but epilepsy and no anti-seizure medication will work. We always knew this and its in Dr. Roberts medical text but now there is a study to prove it. No wonder Searle's Vice President threatened Dr. Richard Wurtman if he did studies on aspartame and seizures his research funds would be denied. They were. Dr. Wurtman no longer speaks out on aspartame.

Arthur Hayes goes over Postmarketing Surveillance. He says if experience demonstrates a lack of safety the FDA is able to take steps to remove it from the market. When the Community Nutrition Institute in Washington DC petitioned the FDA to ban aspartame because of the seizures and blindness FDA refused. In fact, in l985 it was admitted in Congressional hearings the FDA was getting so many complaints on aspartame they were referring them to the AIDS Hotline. Yes, the new FDA, responsible to solve the problem BECAME THE PROBLEM.

Hayes ends by saying that the FDA and the medical profession, from differing but overlapping perspectives, share a direct interest in making sure that technology yields the greatest benefit to society at the least possible risk. Yet, Hayes two months earlier had approved a deadly poison with full knowledge creating an ignored epidemic in now over 100 countries of the world. Aspartic acid, 40% of aspartame is an excitotoxin (Excitotoxins: The Taste That Kills, Russell Blaylock, M.D., http://www.russellblaylockmd.com), the free methyl alcohol is a neurotoxin, 10% by weight, and the phenylalanine, 50%, as an isolate a neurotoxin. The molecule breaks down into diketopiperazine, a brain tumor agent. The Ramazzini Studies in Italy show aspartame to be what the FDA has always known, a deadly multipotential carcinogen, even in small amounts. The Trocho Study in Barcelona shows the formaldehyde converted from the free methyl alcohol embalms living tissue and damages DNA. When you damage DNA you can destroy humanity. Hayes even discusses as a public health agency, the FDA has a continuing responsibility to provide the public with accurate and timely information about the health implications of the products it regulates.

Read this article written by Arthur Hull Hayes who knew the truth about aspartame and how poisonous it is, over-ruled the Board of Inquiry of the FDA and released it on the market, then had the brazenness to write this article as if he believed in safety. Then read the article below my signature by Cynthia Drasler, "A Crisis in Confidence: What Happened To the Old FDA?" The newspaper article above answers her question, Arthur Hull Hayes was appointed FDA Commissioner. Today the FDA are nothing but puppets for Big Pharma and they serve above the law. The Citizens Petition for Ban of aspartame I wrote 6 years ago has never been answered even though the law requires it do so in 180 days. Mitchell Cheeseman who heads the Additives Division refuses to even answer my phone call. The amendment regarding an imminent health hazard has also been ignored that must be answered in a week or ten days and was sent in October.

The heros of the old FDA were Dr. Adrian Gross, FDA toxicologist who asked for the indictment of Searle, Dr. Jacqueline Verrett who told Congress all studies on aspartame were built on a foundation of sand and should be thrown out and aspartame has never been proven safe, and Jerome Bressler who wrote the FDA audit. The worst 20%, two mice studies were stricken when FDA retyped it. A FOIA request said the records were confidential and later said they had been destroyed.

Dr. Gross and Dr. Verrett are now deceased but their records will go down in history. They made a difference. Dr. Verrett left behind the book, "Eating May Be Hazardous To Your Health: The Case Against Food Additives." Her summary says it all:

"Obviously, the final question is: What can be done to restore the consumers their right to safe food regardless of economic and political interests? Anyone who has sen the FDA organized an reorganized and scrutinized by Congress knows this is a tough one. Probably the best solution, as some members of Congress have suggested, is to abolish the FDA and start over with a completely new agency free of some of the political pressures."

She also said, "Ralph Nader has another excellent idea to keep administrators and policy-makers from being corrupted. He would write into law a provision that officials who display gross dereliction of their duties could be sued by citizens and would be subject to fines, dismissal and criminal penalties. This provision obviously would be a constant reminder to food protection officials of precisely who their constituency is." Dr. Verrett wrote this book years ago. Finally, Dr. Verrett said: "When science and the public interest win out, it is invariably only after the government has been pushed to the wall by consumer advocates and other public pressure."

May Dr. Adrian Gross and Dr. Jacqueline Verrett rest in peace as we forge on and ask Congress to put an end to this FDA that lies and endangers the lives of the public, serves above the law, and refuses to remove a deadly poison, aspartame, that has caused a global plague. As Dr. James Bowen told the FDA over 20 years ago, "..the only responsible action would be to immediately take aspartame off the market, fully disclose its toxicities, offer full compensation to the injured, public and criminally prosecute anyone who participated in the fraudulent placement of aspartame on the marketplace. That includes those who work so diligently to keep it on the market as well."

Read the article "Food And Drug Regulation 75 Yeas Later" By Arthur Hill Hayes by clicking HERE [RTF Format] (It will open in a new window)

Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: BettyM19@mindspring.com
http://www.wpwhi.com
http://www.whno.net
http://www.dorway.com

Aspartame Toxicity Center: http://www.holisticmed.com/aspartame


A CRISIS IN CONFIDENCE
What Happened To the Old FDA?
By: Cynthia Drasler, MBA
Originally published in the Sept/Oct 2006 issue of Mystic Pop Magazine

Who exactly are these people calling themselves the FDA today, and what did they do with the old FDA? The old FDA was a critical part of the checks and balances set up by Congress to be the arbiter between our American capitalistic business structure and public safety. The old FDA tried hard to protect the American public from over-zealous pharmaceutical companies. They routinely stared down the pharmaceutical industry and kept them on the straight and narrow. They acted like Elliot Nesss untouchables during prohibition. They were fearless, relentless and demanded meticulous, rigorous pharmaceutical testing procedures, with the emphasis on rigor. They were the good guys in the white hats without a hint of scandal in their relationships with the companies they regulated. They were on the side of safeguarding public health, pure and simple. If the old FDA ever approved a drug that killed or hurt people, they changed their procedures to make sure it didn't happen again and Congress was always watching. It was the old FDA that demanded sweeping changes in the way pre-clinical testing was done on all drugs following the thalidomide disaster in the 1950s. Thalidomide was a drug given to pregnant women that caused children to be born without arms and legs. The changes in pre-clinical testing, demanded by the old FDA gave birth to Teratology, the science of how drugs affect developing fetuses. Teratology studies have been required on all drugs since then to prevent another epic disaster like thalidomide from happening again. The old FDA would routinely discipline pharmaceutical companies who submitted sloppy scientific reports. They even threatened to close down the GD Searle Company in the 1970s for substandard testing procedures. These were the actions of the old FDA, the one I remember - the one I miss. The old FDA answered to Congress and Congress answered to the American public. This was a great system; it worked well for all Americans to create a medical industry that was the envy of the world. I miss that system. I miss the old FDA. I really do.

The new 21st century FDA is unrecognizable from the old FDA. The new FDA looks more like the marketing department of the pharmaceutical industry, than a regulator of it. It certainly isn't acting like it has the best interest of the American public at heart anymore. Not only is there a revolving door between members of the FDA and the corporate boards of pharmaceutical companies, but their allegiance seems to have changed from protecting the physical health of the American public to protecting the financial health of the name brand pharmaceutical industry. Scandals are rampant and include the resignation of recent FDA Commissioner Crawford, only 3 months after being confirmed by Congress. He resigned amid allegations of obvious financial ties to companies he was regulating, and lying to Congress. Then there was the USA Today article a few months ago reporting that 54% of the experts hired by the FDA to evaluate drug safety studies have shameful financial ties to the companies they are regulating, and they are completely unapologetic about it. All of this is occurring while the new FDA claims objectivity and concern for the safety of the American public.

Since Congress changed the method of funding the FDA in 1992, its power and budget has grown, but its accountability to the American public has diminished. The new FDAs attitude of omnipotence is understandable since Congress has been unwilling to challenge the new FDA on its decisions since 1992, with few exceptions. Even with the recent Vioxx scandal, there has been an amazing silence from Congress about the accountability of the new FDA. I am deeply disturbed by this lack of Congressional over sight, and consider it a big part of the new FDAs declining image with the public. Because of the recent financial scandals and the fact that a substantial portion of its budget is funded by the pharmaceutical and chemical companies that it regulates, I have personal doubts about the safety of newly approved drugs. For example, when I heard Mercks new vaccine for cervical cancer was recently approved I was skeptical. They are encouraging girls and young women between the ages of 8 and 26 to get the vaccine. My first thoughts were, Should I really make an appointment for my high school aged daughter to get it? Is this vaccine really safe? Did the FDA seriously evaluate it? Or, was the approval more of a haphazard scan of the testing data to get this vaccine on the market fast to help Merck recoup their financial losses from the Vioxx scandal. I'm not sure about anything the new FDA says or approves anymore. Is this vaccine going to be found to be harmful to the girls and young women who receive it 5 years from now? I'm not sure...

Doubt is the legacy of the new FDA. Even as recently as 10 years ago getting FDA approval for a new drug meant it had instant assurance of not only US but also global profitability. Today that is changing. Several European countries have started questioning the new FDAs approval of various drugs and genetically modified foods. FDA approval no longer equates to instant global acceptance. There is a crisis in confidence brewing not only in America but globally about the new FDA's objectives and motives. We are in the beginning stages of it now, and neither the new FDA, Congress, nor the pharmaceutical companies show any evidence of concern.

For years, the new FDA has been trying to shut down the natural supplement industry, thereby eliminating competition for the pharmaceutical industry and eliminating health care choices for Americans. Recently, the new FDA has been targeting bio-identical hormones for removal from the market. If bio-identical hormones are banned, what's their next step? These hormones are identical to the hormones that we have in our bodies. Does this mean the new FDA believes that our natural inborn human hormones are dangerous too? Their basis for wanting to remove bio-identical hormones from the US results from nothing more than a consumer complaint filed by Wyeth Pharmaceuticals (the manufacturer the leading synthetic hormones on the market) after several years of declining sales. Wyeth's sales have been free falling since their synthetic hormones (not bio-identical) were found to be dangerous for some women in the early 2000s. Today, women are choosing more natural options for their hormonal needs, and Wyeth wants to take that option away with the help of the new FDA. The process of name brand pharmaceutical companies filing consumer complaints to the FDA for the sole purpose of eliminating their competition has been increasing in the last few years according to a Washington Post article on July 3, 2006. They have been exploiting a procedural loophole the size of a 747 that was put into place to alert the FDA to safety issues, but has been twisted by their stable of lawyers to try to ban competition. This legal tactic is increasing health care costs by 100s of millions of dollars per month and serves to eliminate our freedom of medical choices. If the name brand pharmaceutical industry is allowed to continue the perversion of this procedure, bio-identical hormones, nutritional supplements and generic drugs will be removed from the market. Only name brand drugs will be allowed and we will be forced to pay whatever the name brand companies want to charge us. Thankfully, Senator Trent Lott (Rep- Miss.) and Senator Debbie Stabenow (Dem-Mich.) are jointly working on a bill to stop this practice. I am heartened by their efforts, it's an important step in the right direction. I would like to see them start a movement to completely overhaul the FDA.

Don't forget that new FDA has approved herbicide and pesticide laced bacteria for insertion into the DNA of genetically modified foods. This approval was given with out requiring anything more than a 90 rat study, designed, conducted and interpreted by the chemical company profiting from it. Also, after requiring almost no testing for these genetically modified foods, the new FDA has refused to require the labeling of them because the manufacturer of the foods doesn't want them labeled. We are coming dangerously close to completely poisoning ourselves with synthetic chemicals (including pharmaceutical drugs) considering the hundreds of thousands of toxic chemicals allowed in every product and food we come in contact with. Is it any wonder why every type of disease is skyrocketing and the cancer rate in America is now one in two?

A growing body of reputable scientific studies link synthetic chemicals used in everyday products to an increase risk for diseases ranging from allergies to cancer. Our bodies are not able to metabolize these synthetic chemicals and they build up in our tissues, over decades of use, suppressing our immune systems until we get sick. The American Medical Association (AMA) has identified a new illness caused by the buildup of toxic synthetic chemicals in our bodies called Multiple Chemical Sensitivities (MCS). MCS is treated by a new medical specialty created by the AMA called the Environmental Medicine Doctor. These doctors are MDs and are usually trained in Allergy/Immunology. Yet despite the fact that the AMA acknowledges the health damage that synthetic chemicals cause, the new FDA just happily keeps approving any request by the pharmaceutical and chemical companies to unleash more synthetic chemicals onto the market with little or no consideration of the consequences to our long term health.

It is up to us to change this. Call your congressional delegates and tell them that you want to stop the FDA from trying to take away alternative medical choices of for the sake of preserving pharmaceutical profits.

Cynthia Drasler, MBA Copyright July 2006.