Posted: 26 April 2004
Dear Jeannie:
I am addressing your recent lies and nonsense on aspartame. That makes FDA guilty of Title 18, Section 1001 of knowingly misinforming the public on aspartame, the same law the FDA themselves used on the original manufacturer of aspartame, Searle, for lying and misinforming. You say, "Aspartame is one of the most thoroughly tested and studied food additive the Food and Drug Administration (FDA or the Agency) has ever approved. More than 100 toxicological and clinical studies reviewed by FDA confirm that aspartame is safe for the general population." Now here's the real truth of the matter on those studies:
On January 10, l977 in a 33 page letter, FDA Chief counsel Richard Merrill recommended to U.S. Attorney Sam Skinner that a grand jury investigate Searle for "apparent violations of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 331 (e), and the False Reports to the Government Act, 18, U.S.C. 1001, for "their willful and knowing failure to make reports to the Food and Drug Administration required by the Act, 21 U.S.C. 355 (i), and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of aspartame." The FDA calls special attention to studies investigating the effect of NutraSweet on monkeys and hamsters.
Both U.S. Prosecutors Sam Skinner and William Conlon hired on with the defense team and the statute of limitations expired. Who does that surprise? We know the power of the pharmaceutical industry. Don't want to get indicted just hire the prosecutors. When the District Attorney goes to work for the godfather expect acquittal.
In August, l977 The Bressler Report (FDA audit) compiled by FDA investigators and headed by Jerome Bressler, was released. The report found 98 of the 196 animals died during one of Searle's studies and weren't autopsied until later dates, in some cases over one year after they died. Records for approximately 30 animals showed substantial differences between original observations on pathology sheets and the observations on pathology sheets submitted to the FDA. There were numerous other inconsistencies and errors noted. For example, a rat was reported alive, then dead, then alive, then dead again; a mass, a uterine polyp and ovarian neoplasms were found in animals but not reported or diagnosed in Searle's reports. The FDA investigators found dose-related uterine polyps in 15% of 34 animals.
And you have the audacity to say aspartame is safe? And this is just the tip of the iceberg. I personally spoke to Jerome Bressler as did Dr. H. J. Roberts and Dr. Russell Blaylock.
We were all told that the studies were so bad that when the report was retyped the FDA left out 20% of the most damning part. Dr. Roberts had his congressman have the FDA release the other 20% omitted, as well as a cover letter and two mice studies Bressler mentioned but FDA refused. Let me remind you again about Merrill's letter to U.S. Prosecutor Sam Skinner "FOR CONCEALING MATERIAL FACTS AND MAKING FALSE STATEMENTS". That's what the FDA is doing!
For 16 years FDA themselves refused to allow aspartame on the market. In l974 Dr. J. Richard Crout, the acting director of the FDA Bureau of Drugs stated that "The information submitted for our review was limited to narrative clinical summaries and tabulated mean values of laboratory studies. No protocols, manufacturing controls information or pre-clinical data were provided. Such deficiencies in each area of required information precluded a scientific evaluation of the clinical safety of this product....." (Mullarkey 1992, page 23)
March 24, l976 The FDA task force reports, "At the heart of the FDA's regulatory process is its ability to rely upon the integrity of the basic safety data submitted by sponsors of regulated products. Our investigation clearly demonstrates that, in the G. D. Searle Company, we have no basis for such reliance now." The task force further says, "Some of our findings suggest an attitude of disregard for FDA's mission of protection of the public health by selectively reporting the results of studies in a manner which allays the concerns of questions of an FDA reviewer." (FDA Searle Investigation Task Force Chaired by Carlton Sharp. "Final Report of Investigation of G. D. Searle Company." 3/24/76)
Tell me Jeannie Ertter-Prego, when did aspartame become safe? Everything in the records shows aspartame was never proven safe. Do you want to hear some of the findings summarized from various documents describing the FDA Task Force Report?
"Failure to report to the FDA all internal tumors present in the experimental rats, e.g., polyps in the uterine, ovary neoplasms as well as other lesions." (Gross l987a, page8)
In at last one study, the aspartame 52 weeks monkey study, the protocol was written after the study had been initiated." (Gross l985, page S10835)
"They (G. D. Searle) lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study. As I say filter and just present to the FDA what they wished the FDA to know and they did other terrible things for instance animals would develop tumors while they were under study. Well they would remove these tumors from the animals."
FDA Lead Investigator and Task Force Team Leader, Phillip Brodsky described the l975 FDA Task Force members as some of the most experienced drug investigators. He went on to state that he had never seen anything as bad as G. D. Searle's studies (Graves l984; page S5499 of congressional Record l985a)
FDA Commissioner at the time, Alexander Schmidt stated (Graves l984, page S5497 of Congressional Record l985a):
Dr. Marvin Legator, professor and director of environmental toxicology at the University of Texas and the pioneer of mutagenicity testing at the FDA from l962 to l972 was asked by Common Cause Magazine to review the FDA investigation results of G. D. Searle's tests (Graves l984, page S5498 of Congressional Record l985a)
"All tests were scientifically irresponsible and disgraceful. I'm just shocked that the kind of sloppy work would even be sent to FDA, and that the FDA administrators accepted it. There no reason why these tests couldn't have been carried out correctly. It's not that we are talking about some great scientific breakthrough in methodology."
So Dr. Gross said because of their deliberate misconduct and "lies" it invalidated their experiments for the following reasons:
So what was the problem in showing safety? Aspartame is a neurotoxic drug and chemical poison. You can't do studies on a poison and make it show safety. It can't be done. This is why on August 4, l976 G. D. Searle representative met with the FDA and convinced them to allow Searle to hire a private agency, University Associated for Education in Pathology (UAREP) to "validate" some studies (Gordon l987 page 498 of US Senate l987). This is one of the more outrageous things Searle did because they "swore them to silence". And for this they were paid $500,000. As described by Florence Graves (l984, page S5500 of Congressional Record l985a) "The pathologists were specifically told that they were not to make a judgment about aspartame's safety or to look at the designs of the tests."
So let's just skip down to the FDA's final word on aspartame and safety. It was June 1, l979 when the FDA established a Public Board of Inquiry of the finest scientists they had to offer to rule on safety issues surround NutraSweet. On January 15, l980 the Board of Inquiry held hearings on objections to aspartame approval. On Sept 30, l980 the PBOI concluded NutraSweet should not be approved because of the brain tumor issue and because the Board "has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive." They said to revoke the petition for approval.
So for 16 years no FDA Commissioner would allow aspartame on the market and all comments were that aspartame had never been proven safe. At the time Don Rumsfeld was CEO of Searle and he didn't care that aspartame could not be proven safe. As discussed in the United Press International investigation of aspartame and the congressional record, Rumsfeld said he would call in his markers and get it approved anyway. He was on Reagan's transition team and the day after Reagan took office he appointed an FDA Commissioner who would approve it, Arthur Hull Hayes. Hayes over-ruled the Board of Inquiry on July 15, l981 and allowed it to be marketed. Then he went to work for the PR Agency of the manufacturer at what some say was $1000.00 a day, and has refused to talk to the press ever since. So safety had nothing to do with the approval of aspartame, just a political ploy by Don Rumsfeld, and he got a lot of money for doing it.
Jeannie, then you say: "Some websites on the Internet and other publications such as Dr. Russell Blaylock's book have attempted to link aspartame consumption to various health conditions such as systemic lupus, multiple sclerosis, vision problems, headaches, fatigue and even Alzheimer's disease. The Agency has not been presented with any credible scientific evidence to support any of these claims, nor is it aware of any evidence presented in peer-reviewed scientific journals that support these claims." First of all, its not "some" it more like a quarter of a million, at least. They say where there is smoke there is fire, this is a blazing conflagration. There is also an Aspartame Toxicity Center to record the cases of the victims which never stop and aspartame detoxification centers where physicians treat the victims. And Mission Possible International is just one of the operations that alerts the public that aspartame is a deadly neurotoxic drug and is in 50 states and more than 22 countries of the world. Dr. Blaylock's book is just one of them getting the facts out so physicians and consumers can be educated on the damaging effect of this neurotoxin. How else would physicians correlate the symptoms and diseases with the culprit with the FDA, industry and professional organizations funded by industry lying. And you have the audacity to say the agency has not been presented with any credible scientific evidence to support any of these claims. You do not think that after having a deadly chemical poison on the market for over 20 years we wouldn't know what it causes? How long did it take for people to understand why thalidomide was doing? And yes, scientific studies were done but you don't think we're stupid enough to believe the manufacturer would publish the studies that showed what the toxin does, do you? First of all, in l983/84 Searle did studies on humans in South America that showed that aspartame destroys the central nervous system (mimics MS) and the brain. They sacrificed people in poor villages to grow brain tumors and brain tumors is what they suffered from as well as seizures. These studies also showed aspartame hardens the synovial fluids and causes agonizing joint pain. Some of the people in the study died and a pregnant woman lost her baby and then disappeared! A notarized affidavit from the translator N. Vera is on www.dorway.com Not only do aspartame manufacturers not publish the damaging studies but they threaten physicians not to do them. Read the UPI investigation on this same web site that shows Searle actually threatened Dr. Wurtman if he did studies on aspartame and seizures his research funds would be rejected and they were. And where do they get their research funds? From ILSE, Life Sciences, made up of aspartame manufactures, and manufacturers like Coke who use the toxin. Dr. Wurtman is at MIT and today they get research funds and Dr. Wurtman no longer speaks out about aspartame. That's the way it's done and you know it. Doctors and professional organizations are paid to say this toxin is safe.
And its the FDA themselves who have supported the manufacturer knowing aspartame is not safe, and resisted proposals from government scientists for comprehensive studies. Gregory Gordon when he was working for the Star Tribune in l996 wrote about this on November 22nd. He said:
"FDA officials have for years resisted proposals from government scientists for comprehensive studies of the safety of the artificial sweetener aspartame, which 100 million Americans consume as NutraSweet. Between the early l980's and l994 scientists at the National Institutes of Environmental Health Sciences (NIEHS) proposed at least four times that the government's leading program for toxicology research fund such studies, the Star Tribune has learned. The government scientists said they wanted the National Toxicology Program to conduct animal studies to resolve questions about the sweetener's cancer risks. After each of these "nominations" NIEHS officials elected not to pursue the research at the urging of FDA officials who said they were satisfied with industry-sponsored research that found no health risks..."
So the FDA while out of one side of their mouth says they would have to see scientific studies, have prevented these scientific studies from being done and replicating the ones that were invalidated years ago. You don't have any defense. The FDA would lie if the truth would do.
Multiple Sclerosis is epidemic. When I lectured for the World Environmental Conference, Dr. Gaylord of the EPA said: "We have an epidemic of MS and lupus and cannot identify the toxin." I answered I was there to lecture on MS and lupus and identify the toxin as NutraSweet. Not only were scientific studies done by Searle in South America and not published which is a crime, but a good deal of the population using aspartame long time complain of MS symptoms which are listed on your own FDA report of 92 documented symptoms triggered by this neurotoxin. Dizziness is so prevalent is #2 and the numbness and tingling they experience is #17. They slur their words from the methanol toxicity and speech impairment is also on the list as well as the other neurological symptoms. If its not too late all we have to do is get them off aspartame and their symptoms disappear. Not only has Dr. Blaylock written about it but Dr. H. J. Roberts as well, and his position paper Multiple Sclerosis or Aspartame Disease? is on http://www.dorway.com/nomarkle.html along with my letter to the MS Society quoting Dr. Roberts medical text, Aspartame Disease: An Ignored Epidemic, on the chapter on aspartame and MS, including the mechanism. Cori Brackett is one of those aspartame victims who was diagnosed by the Mayo Clinic with MS, and had a huge lesion. She got off aspartame, walked out of her wheelchair and made a movie to tell the story called Sweet Misery: A Poisoned World. You can even get a copy from her at Cori@soundandfuryproductions.com. Today off aspartame even the large lesion has disappeared. Ermelle Martinez is another one who started using aspartame and was diagnosed as having MS in medical school. She never got to finish thanks to FDA's approval of this neurotoxin. She was ready for a wheelchair when she found out about aspartame and got off of it. Today she is just fine and her large lesion has also disappeared. Alicia Morris was diagnosed by two physicians as having MS, got off her three Diet Coke's a day, and all symptoms disappeared. Her story was in First for Women. And its not just the methanol toxicity but the whole chemical mess. There are so many of these cases they are stacked up for me to answer. Joyce Wilson was also misdiagnosed as having MS but it was too late. I still have her pitiful last letter to Senator Metzenbaum where she said: "It's too late for me, please warn others." And then she died. That's what FDA did when they approved a chemical poison for human consumption. And I notice death is on your report of 92 symptoms as well. I guess you would call that the "ultimate symptom"! Additives by law are suppose to be inert or non-reactive. When something causes over 92 symptoms by your own record, enough diseases to fill up a 1038 page medical, interacts with drugs, vaccines and your other approved toxins like Splenda (sucralose), asculfame potassium, MSG, and even causes death its no additive. It is not only against the law to approve a deadly drug as an additive but especially one that liberates free methyl alcohol.
Dr. John Olney, one of the most renowned neuroscientists on the planet today did the studies on aspartic acid in l970 and found it causes lesions in the brains of mice. He founded the field of neuroscience called excitotoxicity. Neurosurgeon Russell Blaylock, M.D., wrote the excellent book you mentioned, Excitotoxins: The Taste That Kills. And they do kill. An excitotoxin is a product that literally stimulates the neurons of the brain to death causing brain damage. When you think of MS also remember that an excitotoxin unlike a neurotoxin that goes directly into the brain does not cross the blood brain barrier but is secreted into the cerebral spinal fluid by the choroid plexus located in the ventricles of the brain. And there in the brain's lower area and upper terminus of the spinal cord is where Lou Gehrigs, Parkinson's Disease and Multiple Sclerosis damage is most prominent. These critical locations are bathed in the toxin as it removes from the blood. From the third to fourth ventricle there is a narrow canal called sylvian aqueduct which fills with this secretion and washes the roof of the hypothalamus. And this accounts for aspartame damage to the hypothalamus which produces serious and diverse problems including sexual dysfunction. This also is discussed in Excitotoxins and Dr. James Bowen has also discussed it at length.
Do you really think after over 20 years of post marketing reports and physicians treating aspartame victims in the trenches of medical practice all this wouldn't be known? And as to lupus, what is it that you don't understand about aspartame being an adjuvant that forms antigenic tissue, triggering immunologic attack. Dr. Blaylock also wrote on aspartame toxicity for Lancet's Discussion Group where he mentioned lupus. He was discussing the Trocho Study when he wrote about a study using radiolabeled aspartame that indicated attachment of the formaldehyde breakdown product to DNA and that the formaldehyde was cumulative with each dose. He said, "this should be a cause of concern especially so in relation to oncogene activation and in disorders associated with elevated rats of DNA damage, such as lupus and the neurodegenerative disorders. He said Shephard, et al found that aspartame was nitrosated in the GI tract and that in this form was significantly mutagenic. Such nitrosation, according to their findings could also occur in endothelial cells and stimulated macrophages. This would raise concern not only of carcinogenic potential but also the stimulation of free radical generation in blood vessels associated with atherosclerosis. Related to this finding is another report by Hardcastle and Bruch, in which they found that macrophages treated with aspartame produced an excess of leukotrienes and other arachidonic acid metabolites. Yamada, et all found that aspartic acid inhibited melatonin secretion from the pineal gland. It has been shown that aspartame consumption does increase aspartic acid blood levels, especially when consumed with MSG."
Dr. Blaylock ended his report by saying: "With the complexity of the central nervous system it would be irresponsible for the FDA to allow the widespread selling of aspartame without further independent study of the neurophysiological, neurobehavioral and neurochemical effects of high intakes of this drug at all ages using chronic studies. I think it is foolish to ignore the complaints of millions of individuals reporting difficulties with this substance."
But, of course, the FDA doesn't want these studies done as Gregory Gordon pointed out. The FDA knows how deadly aspartame is, and once its documented there is no way to explain the marketing of a deadly drug that has caused a global plague. As Dr. James Bowen told FDA years ago (on http://www.dorway.com) "....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."
Dr. Bowen has also written about lupus and said the ability of methyl alcohol/formaldehyde to create antigenicity, especially as combined in aspartame molecules is so great as to cause severe autoimmune reactions to the tissues deformed by formaldehyde polemerization, adduct formation. The immune system turns against the victim's tissues: Lupus. So why write as if it wasn't so when it is so easy to understand. Dr. Roberts likewise has written about it in his medical text and says it mimics and can trigger lupus.
Vision problems likewise are on your FDA report and are so common they are #6 of 92 symptoms and include blindness. But what would you expect when you approve a product with methanol that converts to formaldehyde and formic acid even in the retina of the eye and destroys the optic nerve. The seizures and blindness are so common with aspartame use that in l986 the Community Nutrition Institute in Washington, D.C. petitioned FDA to ban it on this basis. So don't act like this is something FDA doesn't know, they documented it themselves and then refused to ban aspartame as blindness became epidemic. And don't use words like "attempted to link" as FDA knows fully well what aspartame causes. In fact, so well that it was disclosed in congressional hearings FDA was getting so many complaints they were referring them to the AIDS Hotline to get rid of them. You say "When controlled scientific studies have been conducted to attempt to replicate these anecdotally reported adverse effects or uncover a mechanistic bases for their causation by aspartame"... FDA attempts to prevent these controlled scientific studies from being accomplished while at the same time asking to be provided with credible scientific proof. And you act like you don't know they exist when FDA wrote the report of the symptoms.
Furthermore, when scientific studies are done or peer reviewed reports rather than be accepted by FDA it rebuts them like Dr. Olney's study on the association of aspartame and brain tumors.
You say, "To date, the results of independent studies carried out in government, academic, and private laboratories consistently have been reassuring about the safety of aspartame. FDA is aware of no reports of well-controlled clinical studies that would question the safety of aspartame under normal use conditions." What a lie. Ralph Walton, M.D. did a research paper for 60 Minutes showing that 92% of independent scientific peer reviewed studies show the problems aspartame causes. This is on http://www.dorway.com. And if you eliminate one pro-industry summation and 6 studies that the FDA had something to do with, 100% of independent, scientific peer reviewed studies show the problems aspartame triggers. I can understand why Dr. Walton said that since while the FDA should be independent, it is nothing more than the handmaiden of the pharmaceutical and chemical industry. Only studies funded and controlled by the manufacturer have ever said aspartame was safe, and the manufacturers are pros at fixing studies as the FDA proved themselves. Take the Rowan Study funded by Monsanto on aspartame and seizures. They used 18 subjects for a one day study with one capsule of aspartame, and forgot to mention they gave anti-seizure medication to 16 of them. It's tantamount to smelling the bottle. Then they get it peer reviewed with their power with medical journals and claim they did a scientific peer reviewed study and aspartame doesn't cause seizures. I was just reading today an article titled Why You Can't Trust Medical Journals Anymore by The Washington Monthly, April 1, 2004 (Doctors Without Borders). It talks about researchers with financial ties to drug and biotech companies. It ends by saying "What are we to do with the knowledge that much of what passes as science in medicine is little more than gussied-up marketing?" There is no way to trust industry or the FDA. Dr. Ralph Walton himself did a study on aspartame and Monsanto refused to sell him the aspartame because they could not control it. They obviously knew what would happen. One man had a retinal detachment, another was bleeding from the eyes, conjunctival bleeding, and some said they were being poisoned. The institution had to stop the study.
So you say: "FDA is aware of no reports of well-controlled clinical studies that would question the safety of aspartame under normal use conditions." Read Dr. Walton's report of all these independent studies that have shown that aspartame is not safe, and tell me why you lied when, in fact, FDA has seen them all. No wonder a friend wears a button about the FDA that simply says: "They lie and deny."
Then you want somebody to read your FDA Consumer Magazine with the well known reputation of being a propaganda rag supporting industry. Shame on you Jeannine Ertter-Prego.
Physicians like Doctors Blaylock, Roberts, Olney, Walton and Bowen are giants as aspartame experts. They don't lie like the FDA does, like you have in your note on aspartame. If it wasn't for them putting out truthful information hundreds of thousands more would be dead. You have proven my point in your note. You put down any book that tells the facts on aspartame because you want to stumble the public and have them believe FDA lies. We're not going to allow it to happen, that's why millions of anti-aspartame activists work free to get the truth all over the world.
I read the article in the New York Times about your coverup of the anti-depressants and suicidal tendencies. Aspartame which depletes serotonin triggering manic depression, mood swings, SUICIDAL TENDENCIES, etc. is used by 70 per cent of the population and 40% of our kids. And according to Dr. H. J. Roberts medical text, Aspartame Disease: An Ignored Epidemic, aspartame interacts with ALL antidepressants. FDA couldn't let people know that. When you tell one lie you keep on telling more to coverup the first ones.
Then FDA took ephedra off the market in violation of the Dietary Supplement Act to coverup the fact aspartame damages the cardiac conduction system and causes sudden death. And now that it's off the market and athletes are still dropping dead, what's your excuse! Defibrillators are becoming as common as fire extinguishers! Lots of information on http://www.wnho.net, just click on aspartame. Be sure you read the Diane Fleming story and her petition. Charles Fleming played basketball four times a week while he was addicted to diet pop and other aspartame products for years. It took his life. The police saw the methanol poisoning on autopsy and thought she poisoned him even though there was no evidence and she passed a lie detector test. In fact, she was even the one who called the police. She remains in a Troy, Virginia prison even though the FDA has been notified he died of aspartame and has done nothing. It's this chronic methanol poisoning that affects the dopamine system of the brain and causes addiction. And remember that methanol is classified as a narcotic and FDA allows it even in pediatric products.
What does it take for the FDA to stop serving above the law? I filed a petition for recall almost two years ago and the law states that the FDA has 180 days to answer. Obviously, they don't know how to answer it since I told the FDA its not based on safety because we know its not safe, its based on the fact that I have the FDA records showing it to be a chemical poison and the FDA continues to lie to the public. I also stated I will not accept a packet of Federal Registers and a propaganda rag (FDA Consumer) as an answer as the FDA sends out when they can't answer questions.
I'm still waiting for the FDA to answer one of my letters, since its known for making allegations and never able to back them up. I'm waiting for you to show me how you can say aspartame is safe when I have copies of your original records showing it not to be safe.
You people don't even have the decency to put a warning for pregnant women knowing full well that aspartame is a teratogen as discussed by Louis Elsas, M.D., Pediatric Professor, genetics, below. How many millions of babies have been murdered in their mother's womb because of your lies. You will notice also below Dr. Blaylock's excellent letter to the Miami Herald in answer to them publishing a letter from NutraSweet's front group, the Calorie Control Council. Take a lesson in integrity from this outstanding physician.
You will also see below a press release on aspartame lawsuits, and this is only the beginning. I leave you with the words of your own late FDA toxicologist, Dr. Adrian Gross, when he testified before Congress. He said aspartame without a shadow of a doubt can trigger brain tumors and brain cancer, and violated the Delaney Amendment which forbid putting anything in food you know will cause cancer. "And if the FDA violates its own laws who is left to protect the public?" Obviously, the public has no protector because of the existence of your government agency pushing unsafe food and drugs while trying to snatch safe supplement for industry.
[Copies of these articles were sent along with this letter]: