This is a letter published with the permission of Dr. Betty Martini, D.Hum, Founder of Mission Possible International to Hawaii Senate Health Chair, Sen. David Ige, who although signed the Hawaii Senate Resolution asking FDA to rescind approval for aspartame, ended up in fact never scheduling it for the obligatory hearing in his Senate Health Committee, thus killing the Resolution that he had signed with ten other Senate Committee Chairs and Vice Chairs!
What inexplicable behaviour! Was it lobbyists from Monsanto, Coke, and Ajinomoto who got to him? Or was it his own addiction to Diet Sodas?
April 28, 2008
Dear Senator Ige:
The Senate Resolution, SCR 191, regarding aspartame, was so damning, you felt it had to be a hoax, and requested references which were immediately sent. Even this short resolution as damning as it was about this deadly addictive excitoneurotoxic carcinogenic drug that interacts with virtually all drugs and vaccines could not convey every horrible fact.
Many years ago I met a woman who had met one of the three scientists who had worked on the project. He was known to travel telling people to avoid NutraSweet at all costs because it should never have been approved. He was also on the Phil Donahue show back in the early l980's explaining how aspartame is a seizure triggering drug, and anti-seizure medication won't work. He had pleaded with Searle not to approve this deadly drug and finally left in disgust. I was very concerned with the fact the woman said that he was elderly and admitted he might not live to see the day when people would just be dropping dead in the streets from aspartame. Today that is happening.
So many athletes have dropped dead that Dr. Russell Blaylock, author of Excitotoxins: The Taste That Kills, www.russellblaylockmd.com wrote a warning. Here is that Athlete Alert: http://www.wnho.net/aspartame_msg_scd.htm Dr. H. J. Roberts who wrote the 1000 page medical text, Aspartame Disease: An Ignored Epidemic, www.sunsentpress.com likewise wrote a paper on Aspartame and Sudden Death: http://www.wnho.net/aspartame_and_arrhythmias.htm Here's one I wrote as well to the FDA: http://www.wnho.net/openlettertofda.htm Some years ago two European Parliamentarians petitioned the World Health Organization because they couldn't understand why people were dropping dead for no reason. They suggested it should be called sudden death syndrome so it could be tracked. Even young student athletes in schools are dropping dead.
Do not think that Searle who originally made this poison doesn't know how deadly aspartame is. First of all, pharmaceutical and chemical companies are known to do studies out of the country to find out how damaging products are they are concerned about. In the case of aspartame Searle did studies in six countries sacrificing people in poor villages who wouldn't be missed. An affidavit from the translator explained how aspartame destroyed the brain and central nervous system. She said subjects in 18 months got brain tumors and had all types of seizures, and aspartame hardened the synovial fluids. The pregnant woman lost her baby, hemorrhaged and then disappeared. Some died.
Searle was very good at telling people that aspartame is the most studied product and 200 studies have been done showing safety. What Searle didn't say was that in these studies they couldn't prove safety so they committed fraud, and they got caught. Here is the Bressler Report or FDA audit which explained how Searle was filtering out neoplasms, and they were even excising brain tumors from the rats, putting them back in the study and then resurrecting them on paper. The report found that 98 of the 196 animals died during one of Searle's studies and weren't autopsied under 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. 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. Interestingly I called Jerome Bressler when he retired from the FDA and thanked him for being honest and telling the public the truth. He told me that it was a lot worse than what I had read in the FDA audit because the FDA had retyped his report and it was so damning, they left out the worst 20%, two mice studies.
Doctors H. J. Roberts and Russell Blaylock also spoke with Jerome Bressler and were told the same thing so Dr. Roberts asked his Congressman to get the omitted part of the report. The FDA refused the congressman saying it was confidential. I recently wrote a FOIA report for it and was told it was confidential. When I said that this audit was a matter of public record all of a sudden it became destroyed. http://www.mpwhi.com/fda_gate.htm
On January 10, l977 in a 33 page letter, FDA Chief Counsel Richard Merrill recommended to US Attorney Sam Skinner that a grand jury investigate Searle for "apparent violations of the Federal Food, Drug, and Cosmetic Act, 21 USC 331 (e) and the False Reports to the Government Act 18 USC 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
Instead of indicting Searle, Sam Skinner hired on with the defense team. So U.S. Prosecutor William Conlon was asked to take over. He, too, hired on with the defense team and the statute of limitations expired. http://www.mpwhi.com/drug_testing_falsified.htm
The FDA at that time had absolutely no intention of allowing aspartame on the market. Here are some remarks made at the FDA Task Force:
"At the heart of 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 case of G. D. Searle Company, we have no basis for such reliance now."
"We have noted that Searle has not submitted all the facts of experiments to FDA, retaining unto itself the unpermitted option of filtering, interpreting, and not submitting information which we would consider material to the safety evaluation of the product... Finally, we have found instance of irrelevant or unproductive animal research where experiments have been poorly conceived, carelessly executed, or inaccurately analyzed or reported."
"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 allay the concerns of question of an FDA reviewer." "Unreliability in Searle's animal research does not imply, however, that its animal studies have provided no useful information on the safety of its products. Poorly controlled experiments containing random errors blur the differences between treated and control animals and increase the difficulty of discriminating between the two populations to detect a product induced effect.
A positive finding of toxicity in the test animals in a poorly controlled study provides a reasonable lower bound on the true toxicity of the substance. The agency must be tree to conclude that the results from such a study, while admittedly imprecise as to incidence or severity of the untoward effect, cannot be overlooked in arriving at a decision concerning the toxic potential of the product."
It would be very easy to give you another 50 pages of the horrors of original aspartame studies. You simply can't take a deadly chemical poison and have it show safety. It can't be done. Searle got caught constantly.
For instance in the aspartame (DKP) 115 week rat study the written observations of the pathology report was changed by the supervising pathologist, Dr. Rudolph Stejskal even though he was not physically present during the autopsies and could not have verified the observations of the pathology who did perform the autopsies. The pathologist who did perform some of the autopsies had no formal training for such procedures. (Gross l985, page S10837 of Congressional Record l985b).
You could go from study to study and show the fraud. For instance in the aspartame 46 week hamster study, blood samples reported in the submission to FDA as 26 week values (for certain specified animals) were found by investigators as being, in fact, values for different animals which were bled at the 38th week. Many of the animals for which these values were reported (to the FDA) were dead at the 38th week." (Gross 1985, page S10838 of congressional record l985b).
There were "clerical or arithmetic errors which resulted in reports of few tumors." (Schmidt 1976c, page 27 of US Senate l976b). G. D. Searle "delayed the reporting of alarming findings." (Schmidt 1976c, page 27 of US Senate 1976b).
Dr. Adrian Gross, FDA toxicologist who was on site really summed it up when he said:
"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." Wilson l985
FDA lead investigator and Task Force Team Leader, Phillip Brodsky described the 1975 FDA Task Force members as some of the most experienced drug investigators. He went on to state that he had never seen anything as bas as G. D. Searle's studies (Graves 1984, page S5499 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 1962 to 1972 was asked by Common Cause Magazine to review the FDA investigation results of G. D. Searle's tests (Graves 1984, page S5498 of Congressional Record 1985a):
"All tests were scientifically irresponsible and disgraceful. I'm just shocked that that kind of sloppy work would even be sent to FDA, and that the FDA administrators accepted it. There is 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."
Senator Edward Kennedy at the April 8, 1976 hearings before the Senate Subcommittee on Labor and Public Welfare stated (Kennedy l976): "The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing."
Senator Ige, this is what we know: no doubt a lot was hidden. In fact, Dr. Adrian Gross said the deliberate misconduct and lies invalidated all their experiments for these reasons:
1. Many of the problems with the studies included horrendous experimental designs, questions regarding dosage given, loss of animal tissue and data, etc.. which invalidates entire experiments and causes what they claim to be 4 million observations and calculations per study (average) to become irrelevant.
2. Only the key aspartame studies were looked at. It is almost a certainty that the non-key aspartame studies were equally flawed. Therefore, this would invalidate the "hundreds of millions" of observations and calculations made during these studies.
3. The difference between a study showing no statistical difference and a significant statistical difference is often only a few observations or calculations. Therefore, had the myriad of other serious experimental errors not occurred, the observation and calculation mistakes in each experiment investigated would, by themselves, invalidate most of the key studies.
4. It is highly unlikely that the FDA Investigative teams found all of the problems with G. D. Searle's studies. G. D. Searle seemed so intent on covering up their misconduct, that it is quite likely that they were able to hide many of the problems from the FDA.
So you see, Senator Ige, no matter what the aspartame industry says, about aspartame being the most tested additive in history and showing safety, the public record shows aspartame never showed safety at all. What it did show was massive fraud, and they got out of it by buying the U.S. Prosecutors who were never investigated for not doing their job and instead going to work for the defense team.
So FDA revoked the petition for approval. Here is that report. http://www.mpwhi.com/fda_petition1.doc
Before the FDA Commissioner, Dr. Jere Goyan could sign this into law, the next day Searle filed suit. Don Rumsfeld was CEO of Searle, hired to get them out of trouble. He said he would call in his markers and get aspartame on the market anyway. What were those markers?