EFSA's Review of Ramazzini’s Second Aspartame Study Shows Sellout


In 2005 the prestigious Cesare Maltoni Cancer Research Center at the European Foundation for Oncology and Environmental Sciences published the results of their 3 year aspartame study on 1,800 rats, known as the Ramazzini Study. It was the most scrupulous and costly investigation of the chemical sweetener ever performed. Dr. Morando Soffritti led this groundbreaking research that revealed aspartame causes lymphomas and leukemia and is a “multipotential carcinogen.”


Now the European Food Safety Authority [EFSA] was on the spot. Would they cover their eyes and keep this poison on the market, destroying the health and lives of millions? Of course! EFSA’s Dr. Herman Koeter, admitted that commercial pressure controlled them with these words in the article "EU's Food Agency Battles Attempts to Hijack Science":

"Science and politics make poor bedfellows. Just ask Herman Koeter, deputy executive director at the European Food Safety Authority (EFSA) which has felt the push and pull of national politics ever since the agency began operating four years ago. ...Along the way he also described the various political pressures EFSA faces as it strives to maintain a firm line between its independent scientific research and the mire of EU politics...."Hot decisions that had political repercussions included … A REVIEW OF A CONTROVERSIAL ASPARTAME STUDY.


"Pressure comes from the European Commission, national legislators, regulatory agencies and industry to tone down or beef up results. Sometimes the pressure comes in the form of a push for a firm opinion on controversial subjects, when science is unable to yield a clear answer, Koeter said”

Under such pressure EFSA gave aspartame a green light! Now Dr Soffritti executed another flawless unimpeachable study, peer reviewed by 7 world experts which further condemned aspartame as unfit for humans or rats.

EFSA stepped into the breech to protect the producers not the population, declaring, in part:


· The majority of the lymphomas and leukemias observed appeared to have developed in rats suffering from inflammatory changes in the lungs, which is characteristic for chronic respiratory disease. In accordance with the previous view of the AFC Panel, these changes were not considered to be related to the treatment with aspartame.



TRANSLATION: The cancer-saturated rats had inflamed lungs. We think that’s meaningless.

REALITY: Respiratory inflammation is part of the dying process!



· * The increase in incidence of mammary carcinoma is not considered indicative of a carcinogenic potential of aspartame since the incidence of mammary tumours in female rats is rather high and varies considerably between carcinogenicity studies. The Panel also noted that an increased incidence of mammary carcinomas was not reported in the previous ERF study with aspartame, which used much higher doses of the compound.

TRANSLATION: Female rats get breast cancer. We don’t think that counts.

· REALITY: When they consume aspartame mammary tumours multiply.



Read EFSA’s outrageous, unprincipled head-in-the-profitable-sand decision and the statements of fine medical experts motivated by medical reality and their commitments to prevent illness, not political persuasion.



Dr. Ken Stoller declared: "EFSA's position on aspartame is a testament to the power of corporations to influence, compromise and corrupt the safety nets that have been put into place to protect the public."

Here are the facts of the second Ramazzini Study:



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.

When Dr. M. Soffritti, the lead researcher on the two studies, lectured at New York's Mt. Sinai School of Medicine he was honored for his outstanding contributions to the identification of environmental and industrial carcinogens and his promotion of independent scientific research.

It was Ralph Walton, M.D. doing research for 60 Minutes who showed the importance of "independent" scientific peer reviewed research in his report titled: "Survey of Aspartame Studies: Correlation of Outcome and Funding Sources:  http://www.dorway.com/peerrev.html 92% of independent research showed the problems aspartame causes and if you eliminate 6 studies the FDA had something to do with when they became influenced by aspartame manufactures and one pro-aspartame summary, 100% of ALL independent studies show the problems.

EFSA’s mammary tumor excuse is preposterous. It's always been known aspartame triggers mammary tumors. Writer Alex Constantine explains:

"G. D. Searle (original manufacturer) submitted a battery of cancer-test results, titled the Willigan Report, which contained a statistical table that wrongly excluded four malignant, aspartame-related mammary tumors detected by Dr. Willigan and incorporated in his initial data. Somehow, the malignancies were made to appear benign. Searle dismissed the misrepresentation as a computer error, claiming that the unfavorable mammary malignancy data were innocently omitted from the summary table four separate times by three different individuals."

Also, read the Bressler Report, the FDA audit:  http://dorway.com/dorwblog/?page_id=56 When Jerome Bressler’s report was retyped two mouse studies were left out. Obviously the two studies were too horrible for the public to read. FDA told me they destroyed. FDA tried to have Searle indicted but both US Prosecutors Sam Skinner and William Conlon hired on with the defense team; the statutes of limitation expired. Now that's industry influence!!!

Citizen scientist Victoria Inness-Brown, M.A. reported in her aspartame study 67% of female rats developed tumors and one mammary tumor was so large the rat used it as a pillow. She also said: "My rats on aspartame also developed other apparent health issues, such as paralysis, difficulty walking, spasmodic torticollis (also called dystonia, where the neck is twisted and the head continually tilted to one side), infected and blood eyes, skin lesions, thinning and yellowing fur, and obesity-which is said, because people often use aspartame to lose weight."

In Dr. Soffritti's studies the rat’s hair yellowed from the formaldehyde. Formaldehyde is converted from the methyl alcohol, a severe metabolic poison. In the Trocho Study  http://www.mpwhi.com/formaldehyde_from_aspartame.pdf it shows the formaldehyde embalms living tissue and damages DNA. When this devastating independent study was published Dr. M. Alemany reported the aspartame manufacturer resorted to character assassination. When you damage DNA you destroy humanity! !

California Proposition 65 has a "nasty" list of ingredients that if found in products coming into that state must require a cancer warning. Two of the nasties are methanol and formaldehyde! The methyl ester in aspartame immediately becomes methyl alcohol and then converts to formaldehyde.  http://www.mpwhi.com/letter_to_cynthia_oshita.htm

EFSA’s excuses about respiratory disease were answered by Dr. Soffritti but they decided to see if they could get away with their fable a second time.

Dr. Soffritti said:

"In examining the raw data of our study, the EFSA (2006) observed a high incidence of chronic pulmonary inflammation in males and females in both treated groups and in the control group. Based on this observation, it was concluded that "the increased incidence of lymphomas/leukemias reported in treated rats was unrelated to aspartame, given the high background incidence of chronic inflammatory changes in the lungs . . . ." In my opinion, this conclusion is bizarre for the following reasons:

"First, the EFSA (2006) overlooked the fact that the study was conducted until the natural death of the rodents. IT IS WELL KNOWN THAT INFECTIOUS PATHOLOGIES ARE PART OF THE NATURAL DYING PROCESS IN BOTH RODENTS AND HUMANS.

"Second, if the statistically significant increased incidence of lymphomas/leukemias observed were indeed caused by an infected colony, one would expect to observe an increased incidence of lymphomas/leukemias not only in females but also in males. The EFSA (2006) did not comment on this discrepancy in their logic.”


H. J. Roberts, M.D., FACP, Palm Beach Institute for Medical Research, who authored the 1000 page medical text, Aspartame Disease: An Ignored Epidemic, also reviewed EFSA's deceptive report. He said, "The ongoing attempts to ridicule clinical, epidemiologic and experimental studies warning of probable carcinogenic effects of aspartame products are both dubious and retrogressive -- particularly in the case of brain tumors, breast cancer and leukemia/lymphoma. I have reviewed the evidence in my corporate-neutral publications, and in submissions to the legislatures of several states seeking to ban the products and the European Food Safety Authority. This is not an academic consideration when over half the population has been consuming these products. Moreover, I disagree with the AFC Panel that there is no reason to revise the ADI for aspartame of 40 mg/kg bw... as detailed in my texts. www.sunsentpress.com

FDA toxicologist, Dr. Adrian Gross told Congress an ADI shouldn’t be set on aspartame since it causes cancer.

On August 1, l985 the FDA’s toxicologist, Dr. Adrian Gross, told Congress 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 outlaws 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)

EFSA would you like to answer Dr. Gross' question?

Attorney James Turner, author of "The Chemical Feast: The Nader Report on Food Protection at the FDA, was the consumer attorney who with neuroscientist Dr. John Olney, legally fought the approval of aspartame from 1973 until 1985. He has reviewed with disappointment the European Food Safety Authority panel's original and amended conclusions on the second Ramazzini Study.

Mr. Turner states:

"It is impossible to say that Aspartame is not a carcinogen. This conclusion of the 1980 FDA Public Board of Inquiry remains true today.. FDAs own scientist Dr. Adrian Gross, who worked on the FDA investigative team that revealed dozens of legal volition in the Aspartame's studies conducted by Searle Drug Company, acknowledged that aspartame violated the Delaney Amendment because of this.

"The approval of aspartame was the most contested in FDA history. The sweetener was not approved on scientific grounds but through strong political and financial pressure and through the political chicanery of Donald Rumsfeld who ran the company making aspartame. The European Food Safety Authority argues that the high incidence of cancerous tumors that occurred in the Ramazzini studies are caused by something other than aspartame. However there were high incidences of cancerous tumors in studies provided to support aspartames FDA approval.

"There was also a significant increase in human cancerous tumors like those in animals in the first year of aspartame's use in diet sodas. The record is to damming for any informed individual to risk their own health by consuming aspartame. Aspartame should never have been approved and actions to ban it started soon after approval as victims suffered from seizures, MS, blindness, cancer and death. The FDA listed 92 reactions attributed to this poison.

"When I testified before Congress in 1987, I stated that 'just because a substance reaches the market it should not be treated as sacrosanct. It must be recognized that over time a substance that we know harms people will continue to harm people. .. If the standard of food safety is that a substance that only harms some people, but not all people is going to be allowed on the market, then special policies should be adopted to protect those at risk.' This was never done.

"Since approval, victims of aspartame continue to develop neurodegenerative disease, suffer diabetes, drug interactions, obesity, heart disease and loss of vision. Never has the public been warned that it triggers birth defects, a catastrophe the eminent Dr. Louis Elsas warned Congress about. In fact the average consumer of aspartame is not aware that the European Food Safety Authority says that an acceptable daily intake (ADI) of aspartame is 40 milligrams/kilogram of body weight about the amount in a six pact of diet soda for a 10 year old boy. Nor do they know how to tell if that amount is being exceeded by intake of the more than 5000 food and drug products currently sweetened with aspartame

”Enough from EFSA! The entire aspartame fiasco is documented. The only responsible thing to do is ban it. And if they refuse to ban it, then it should carry heavy warnings including a statement of the ADI and the amount of aspartame in every product. The Ramazzini Study has confirmed twice what the FDA knew from the beginning. To loose upon an entire unwarned continent a chemical that destroys the fetus, triggers mental illness and cancer, and sickens millions without a word of warning is corrupt and depraved. EFSA is responsible to prevent such depredations not simply protect the greedy pockets of poison producers.

Mr. Turner tells the story of aspartame approval in Sweet Misery: A Poisoned World. Here is that clip:
 http://www.soundandfury.tv/pages/rumsfeld.html


Russell Blaylock, M.D. Neurosurgeon: Author: Excitotoxins: The Taste That Kills, www.russellblaylockmd.com, commenting on both Ramazzini studies, said: "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 multipotential carcinogenic danger 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 studies 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, that this product should be removed from the market."

James Bowen, M.D., who has Lou Gehrigs disease from aspartame states: “Aspartame grossly fails all toxicity tests. I’m still one of the unbroken scientists who saw the original toxicity studies on aspartame. When aspartame was marketed in carbonated beverages in 1983 the brain tumor rate jumped 10 percent and new cases of diabetes 30 percent. Both have progressed to become epidemics. Aspartame mammary tumors were seen in original studies and now breast cancer is epidemic. We need legislators to face the facts and ban this heinous poison. Read this letter to New Mexico State Senator Gerald Ortiz ye Pino. Note his comments on chemical hypersensitization.  http://www.wnho.net/letter_to_senator_goyp_concerning_aspartame.htm Senator Ortiz ye Pino sponsored the bill to ban in New Mexico.  http://www.rense.com/general74/comn.htm

The nation of Romania banned aspartame in the early l990's because it caused cancer. EFSA must think aspartame only causes cancer in Romania but not the rest of the world

EFSA currently is reviewing aspartame for safety. They will get opinions from scientists worldwide and every one of them will have to be checked out for links to the aspartame industry. They are now reviewing consumer cases often called anecdotes. Dr. Roberts e sent his medical text with hundreds.

" In 1987 Dr. Charles Harris said: "But the medical profession has a tendency to discard out of hand, and disparagingly, "anecdotal" information. Digitalis, morphine, quinine, atropine, and the like are chemical derivatives that stem from anecdotal folklore remedies. After all, one anecdote may be a fable, but 1,000 anecdotes can be a biography.... A vital function of the medical profession is to sift anecdotes and submit them, if possible, to scientific evaluation. But it all starts as anecdote." (1987 Medical Tribune, reprinted in Aspartame Disease: An Ignored Epidemic by H. J. Roberts, M.D.)

Dr. Maria Alemany, the courageous researcher who did the Trocho Study, told me in Barcelona: "Aspartame is going to kill 200 million people". Many of them are already buried.

EFSA should apologize to Dr. Soffritti and the public for their critical review, which misleads people to use this addictive, excitoneurotoxic carcinogenic drug, a deadly genetically engineered chemical poison.

For those wanting to ban aspartame from your state or country please contact me or Stephen Fox, Mission Possible New Mexico ( stephen@santafefineart.com)

Dr. Betty Martini, D.Hum, Founder
Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097
770 - 242-2599
www.mpwhi.com, www.dorway.com, www.wnho.net
Aspartame Toxicity Center, www.holisticmed.com/aspartame
Aspartame Information List, www.mpwhi.com, scroll down to banners
 Bettym19@mindspring.com

EFSA REVIEW:

Summary

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the results of a long-term carcinogenicity study with prenatal exposure to the artificial sweetener aspartame, performed by The Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation (ERF) and published in June 2007 by Soffritti et al.. The authors concluded that the results of their study not only confirm, but also reinforce their first experimental demonstration (published in 2005 and 2006) of aspartame's multipotential carcinogenicity at a dose level close to the human Acceptable Daily Intake (ADI). Based on the results of this study, the authors further postulated that when lifespan exposure to aspartame begins during fetal life, its carcinogenic effects are increased.

During the 1980s, aspartame has been authorised for use in foods and as a table-top sweetener by several Member States, and European legislation harmonising its use in foodstuffs was introduced in 1994 following thorough safety evaluations by the Scientific Committee on Food (SCF) in 1984 and 1988. Further reviews of aspartame data were carried out by the SCF in 1997 and 2002. In 2006, the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) assessed a long-term carcinogenicity study on aspartame performed by the ERF and published by Soffritti et al. in 2005 and 2006. Based on all the evidence available from the ERF study and other recent studies and previous evaluations, the AFC Panel concluded that there was no reason to revise the previously established ADI for aspartame of 40 mg/kg bw (EFSA, 2006).

In the second ERF study on aspartame in rats, published in 2007, dietary concentrations of 400 and 2000 mg aspartame/kg diet equivalent to doses of 20 and 100 mg aspartame/kg bw/day were used. The rats were exposed to aspartame from the 12th day of gestation until natural death. The group size was 95/sex in the control and 70/sex in the low- and high-dose groups. The authors reported a significant dose-related increase of malignant tumour-bearing males, particularly in the high-dose group (p<0.01, Cox regression model), a significant increase in incidence of lymphomas/leukaemias in males from the high-dose group (p<0.05), a significant dose-related increase in incidence of lymphomas/leukaemias in females (p<0.01), particularly in the high-dose group (p<0.01), and a significant dose-related increase in incidence of mammary carcinomas in females (p<0.05), particularly in the high-dose group (p<0.05).

The Panel's assessment of the ERF carcinogenicity study with prenatal exposure on aspartame as reported by Soffritti et al. was directed towards establishing the relevance of the reported findings to human health. In carrying out its assessment the main information available to the Panel was the published paper, in which the presentation of pathological findings was restricted to the incidence of malignant tumours, total number of malignant tumours per group, incidence of lymphomas/leukaemias, and incidence of mammary carcinomas. Further data from this study were requested by EFSA in April 2007, January 2008 and July 2008 in order to aid the interpretation of the study. On 19 February 2009, the Ramazzini Institute submitted to EFSA some of the requested data.

The Panel concluded that:
* Evaluation of aggregated malignant tumour incidences as evidence of carcinogenic potential of the test compound can only be performed based on a thorough consideration of all tumour data including onset, and data on non-neoplastic, hyperplastic and preneoplastic lesions but these data were not provided by the authors. Limited information on the presence of inflammatory changes in the lungs of animals with lymphomas and leukemias were provided by the ERF in the additional submission.
* The majority of the lymphomas and leukemias observed appeared to have developed in rats suffering from inflammatory changes in the lungs, which is characteristic for chronic respiratory disease. In accordance with the previous view of the AFC Panel, these changes were not considered to be related to the treatment with aspartame.
* The increase in incidence of mammary carcinoma is not considered indicative of a carcinogenic potential of aspartame since the incidence of mammary tumours in female rats is rather high and varies considerably between carcinogenicity studies. The Panel also noted that an increased incidence of mammary carcinomas was not reported in the previous ERF study with aspartame which used much higher doses of the compound.

Overall, the Panel concluded, on the basis of all the evidence currently available including the last published ERF study that there is no indication of any genotoxic or carcinogenic potential of aspartame and that there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw/day.