From: Dr. Betty Martini, D.Hum., Bettym19@mindspring.com
To: " Commissioner@fda.gov, email@example.com, firstname.lastname@example.org, "Jaffe Lyle D" LJAFFE@OC.FDA.GOV, email@example.com, firstname.lastname@example.org
Date: Thu, Jun 28, 2007 12:44 am
Subject: FDA, EFSA to Review New Aspartame Study
To the FDA:
I'm glad you will review the new Ramazzini aspartame study, it's a good step. Now take the next one: tell the public FDA knew that aspartame is a deadly carcinogen decades ago and courageously fought the poison for years, denying approval because it causes brain tumors and can't be proven safe. FDA even asked the Justice Department to prosecute NutraSweet for submitting fraudulent data. Their lawyers simply bought the prosecutors and the case expired with the Statute of Limitations. See the Board of Inquiry report revoking NutraSweet's petition for approval. http://www.wnho.net/fda_petition1.doc
FDA was the political victim of Don Rumsfeld, NutraSweet's boss, who joined the Reagan administration and got new Arthur Hayes installed as FDA commissioner. Hayes-the-Rat overrode your scientists and blessed it in 1981, then scurried away to a fat job in the aspartame biz. Washington Atty. James Turner tells the tale in Sweet Misery: A Poisoned World. It's all in the public record. http://www.amazon.com As maladies have multiplied, FDA has ignored the rain of petitions to halt this atrocity. My own Citizens Petition has been stonewalled for 5 years, though law requires your answer in 180 days. You betray the public trust, ignoring complaints, though you once published a list of 92 documented symptoms from 4 types of seizures to coma and death. Now you deny it exists: http://www.wnho.net/92_aspartame_symptoms.pdf
FDA now tells people aspartame is the "most tested product in history", but your own toxicologist, Dr. Jacqueline Verrett, a member of your task force that investigated the research done to establish the safety of aspartame, testified in front of a U.S. Senate hearing in l987 that tests used as the BASIS OF FDA APPROVAL - WERE A "DISASTER and should have been 'THROWN OUT". Verrett said the team was instructed not to be concerned with, or comment upon, the overall validity of the study and that a subsequent review discarded or ignored the problems and deficiencies outlined in her team's original report. Verrett concluded the data in the study was WORTHLESS, and the safety of aspartame and its breakdown products were therefore not determined, and emphasized that aspartame is in the marketplace without basic toxicity information, no data to assess the interactions with DKP, excess phenylalanine, other aspartame metabolites, additives, drugs or other chemicals. (Testimony of Dr. Jacqueline Verrett, Food and Drug Administration Toxicologist, before the U.S. Senate Committee on Labor and Human Resources, regarding "NutraSweet Health and Safety Concerns" 11/3/l987)
Dr. Verrett testified after aspartame was on the market 6 years. It hadn't been proven safe, because it's a poison and you can't prove a poison is safe without crooked tests. But the Hayes-Rat Fix was in. Did original studies show aspartame caused cancer? Your FDA toxicologist, Dr. Adrian Gross, testified before Congress on 8/1/85 that 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. 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 8/1/l985
The FDA Task Force Report nailed these abominably corrupt lab practices: "Excising masses [removing tumors] from live animals, in some cases without histologic examination of the masses, in others without reporting them to the FDA." (Schmidt l976c, page 4 of US Senate l976b). When caught and questioned about these actions the excuse was given: "these masses were in the head and neck areas and prevented the animals from feeding." The tumors were so big they choked the rats Burglars have better alibis! And just how many brain tumors were excised that weren't caught? The comedy continues, accusing the manufacturer of: "Failure to report to the FDA all internal tumors present in the experimental rats, e.g. polyps in the uterus, ovary neoplasms as well as other lesions." FDA caught Searle red-handed filtering out neoplasms, excising tumors from rats, putting the rats back in the study and when they died resurrecting them on paper. But what would you expect, as aspartame breaks down to a brain tumor agent, DKP. There were many tumors found, more mammary tumors than brain tumors, thyroid, pancreatic and testicular tumors, ovarian and uterine, etc. http://www.dorway.com/bressler.txt
WE HAVE ESTABLISHED ASPARTAME WAS NEVER PROVEN SAFE AND IT CAUSES CANCER BY THE STATEMENTS OF FDA TOXICOLOGISTS WHO INVESTIGATED IT! So why are you hiding it now? http://www.wnho.net/whopper.htm
The 3-year Ramazzini Study confirms what FDA already knew. A NY Times article gave FDA's excuse for not banning aspartame - "it would hurt the manufacturers economically." Let people die to protect the producer' profits. You admit you're there to protect the manufacturers and not us. This makes you their Washington Branch office, so we can expect nothing from FDA but industry propaganda! http://www.nytimes.com/2006/02/12/business/yourmoney/12sweet.html?ex=1297400400&en=f5f573accc334534&ei=5088&partner=rssnyt&emc=rss
You showed your hand again when Dr. Soffritti gave a lecture on his new aspartame study that proves it causes cancer at low doses. The day before FDA issued a release not accepting the first study. Your timing was to confuse the people that you were condemning the new study, which you hadn't even seen yet. http://www.laleva.org/eng/2007/04/aspartame_fda_spins_news_on_second_cancer_study.html
After the first study you dragged up a ten-year-old NIH & AARP diet survey asking elderly people what they ate last year. The form had 56 questions. Aspartame was mentioned in one: Which sweetener did you use in your coffee? FDA transformed this into blanket proof of aspartame safety! You're a public agency charged to protect us, not corporations, but you get most of your money from the corporations you regulate. So it's clear why America has the most expensive healthcare on the planet, and some of the worst: You're protecting your paychecks. http://www.wnho.net/halt_the_spin_on_bogus_studies.htm
EFSA, The European Food Safety Authority, reviewed the Ramazzini study, and behold! They reported that the rats had respiratory diseases that caused the cancers. Physicians all know that respiratory disease is part of the dying process, but EFSA folks had to make words to protect their bank accounts, they have financial connections with the aspartame industry. Here's an excuse they could have used: When rats die their temperature drops, so they must have froze to death. Mother Goose! I reported the EFSA to the Universal Court of Justice, so finally Executive Director of EFSA, Dr. Herman Koeter confessed that industry "had pressured them to hi-jack science." http://www.wnho.net/letter_to_efsa.htm
A new study sponsored by Food Standards there showed that additives cause behavioral problems in children, and big UK food chains are removing aspartame from their products. Unfortunately, they're switching to another toxin FDA approved: Splenda, a chlorocarbon poison.
When industry sponsors flawed studies, you don't expose them; others have to do that as you can see from these reports of abuse in aspartame studies:
Scientific Abuse in Methanol / Formaldehyde Research Related to ...
More details about chronic Methanol / Formaldehyde poisoning from aspartame can be found on the Internet at http://www.holisticmed.com/aspartame/aspfaq.html
Scientific Abuse in Seizure Research Related to Aspartame:
In a study looking at 551 aspartame reactors, Roberts (1988) found that grand mal, ... Based on these findings, several research teams have found that ... www.holisticmed.com/aspartame/abuse/seizures.html
Scientific Abuse in Migraine/Headache Research Related to Aspartame:
Cananzi (1995) found increased levels of glutamate in platelets (but not plasma) in ... In a study of migraine and children, D'Eufemia (1997) found that ...
Scientific Abuse and Possible Scientific Fraud in Monsanto Research:
Aspartame and NutraSweet research abuse from Monsanto. This page is specific to the abuse of the methanol and formaldehyde research:
Scientific Abuse in Parkinson's Disease Research Related to Aspartame:
Industry's efforts to show aspartame is safe are criminal. In the Rowan Study on seizures above: Of 18 subjects they gave 16 anti-seizure medication, and then a one day study with one capsule of aspartame. If I can find out what they did, you had to know. Did you ask for all the records to examine this study that you consider showing aspartame safety?
With the impeccable Ramazzini Studies you want particular material because it's your intention to try and protect the manufacturers. There is no precedent for what you want. You did nothing when the manufacturers funded "flawed" studies and asked for nothing.
The Ramazzini Institute knows exactly what you're up to: that what you really want is something you can twist and turn around to attempt to convince the public an impeccable study by a world famous independent research organization is not correct. Kathryn Knowles said it well:
"Kathryn Knowles, director of resource development at ERF told FoodNavigator-USA.com that "the approach of industry and industry-sponsored lobbies is two-fold; first to raise doubts about the credibility of our institution and then about the design or conduct of our studies".
"The ERF has faced similar criticism by industry, lobbies and industry-sponsored scientists almost every time we have published new data on the carcinogenicity of a compound or agent in the last 35 years. Despite these criticisms, it must be noted that experimental data reported by the ERF have not been challenged by epidemiological evidence. It is also interesting that these criticisms are never applied to our carcinogenicity studies when the results are negative."
If the Ramazzini Study had been different and shown aspartame to be safe you wouldn't have asked for a thing, just touted it all over the world, and how prestigious this organization is.
Here are summaries of both studies:
The first ERF study (2005) was conducted on 1800 Sprague-Dawley rats (100-150/per sex/per group). In order to simulate daily human intake, aspartame was added to the standard rat diet in quantities of 5000, 2500, 100, 500, 20, 4, and 0 mg/Kg of body weight. Treatment of the animals began at 8 weeks of age and continued until spontaneous death. The results show that APM causes a statistically significant, dose-related increase of lymphomas/leukemias and malignant tumors of the renal pelvis in females and malignant tumors of peripheral nerves in males. These results demonstrate for the first time that APM is a carcinogenic agent, capable of inducing malignancies at various dose levels, including those lower than the current acceptable daily intake (ADI) for humans (50 mg/kg of body weight in the US, 40 mg/kg of body weight in the EU).
The second ERF study (2007) was conducted on 400 Sprague-Dawley rats (70-95/per sex/per group). In order to simulate daily human intake, aspartame was added to the standard rat diet in quantities of 100, 20, and 0 mg/Kg of body weight. Treatment of the animals began on the 12th day of fetal life until natural death. The results of the second study show an increased incidence of lymphomas/leukemias in female rats with respect to the first study. Moreover, the study shows that when lifespan exposure to APM begins during fetal life, the age at which lymphomas/leukemias develop in females is anticipated. For the first time, a statistically significant increase in mammary cancers in females was also observed in the second study. The results of this transplacental carcinogenicity bioassay not only confirm, but also reinforce the first experimental demonstration of APMs multipotential carcinogenicity.
I'm sending a copy of this to the European Food Safety Authority and hope you both this time will review this study honesty with integrity. Is this too much to ask? You must remove this poison from the market as it even interacts with all drugs, vaccines and toxins. http://www.wnho.net/aspartame_interacts.htm
For those who are using this toxin no drug is safe on the market.
The comments of the Calorie Control Council below should be ignored as they are a notorious NutraSweet front group! http://www.wnho.net/mh_aspartame_letter.htm
Aspartame Disease is a global plague defined in the medical text: Aspartame Disease: An Ignored Epidemic, by H. J. Roberts, M.D. http://www.sunsentpress.com
Russell Blaylock, M.D. author of Excitotoxins: The Taste That Kills, ( http://www.russellblaylockmd.com ) said of these studies:
"My review of the first Ramazzini Study concluded that the study was one of the best-designed, comprehensive and conclusive studies done to date on the multipotent carcinogenic potential of aspartame. This second study is even more conclusive, in that it shows a dose-dependent statistically significant increase in lymphomas/leukemia in both male and female rats exposed to aspartame. These two cancers are the fastest growing cancers in people under age 30.
"Also, of major concern is their finding of statistically significant increases in breast cancer in animals exposed to aspartame. With newer studies clearly indicating that toxic exposures during fetal development can dramatically increase the cancer risk of the offspring, this study takes on a very important meaning to all pregnant women consuming aspartame products. Likewise, small children are at considerable risk of the later development of these highly fatal cancers.
"It should be appreciated that the doses used in these study fall within the range of doses seen in everyday users of aspartame. This study, along with the first study, should convince any reasonable scientific mind, as well as the public at large, that this product should be removed from the market."
This letter recaps aspartame's foul history, a matter of record. Face it, the public, and now the mainstream media are wising up to your lies and foolishness. And that's the rest of the story!
Dr. Betty Martini
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
Aspartame Toxiocity Center: http://www.holisticmed.com/aspartame