GENTECH archive 8.96-97


Another recent article on Aspartame by Gregory Gordon.

Dear Mark:  Thanks so much for this article I hadn't seen.
I'm going to put this on some lists so I'll explain that in the case of
cancer even in the studies funded by NutraSweet there were brain tumors,
pancreatic, uterine and mammary tumors, also seizures and other serious
problems.  These are studies that supposedly proved the safety of
aspartame.  The late Dr. Adrian Gross, FDA toxicologist, admitted to
Congress that aspartame violated the Delaney Amendment.

With regard to complaints mentioned it is true that Dr. Kessler once said
that only 1% of serious problems are repoerted to the FDA and most people
do not know to even associate their problems with aspartame since trade
organizations funded by Monsanto convinces physicians aspartame is an
additive instead of a drug and that it is safe.  In l995 10,000 complaints
were on record although Richard Wilson who lost his wife Joyce to
NutraSweet said they had that many in the early 80's but kept telling
people to call the AIDS Hotline.  

In l996 in order to approve aspartame in everything in the grocery store,
they must have had to show a decrease.  So they said they redid their
bookkeeping system and had to throw out hundreds of aspartame complaints
from the l980's.  Aspartame complaints sent in by Mission Possible were
never counted, and countless people tell us when they attempt to report
reactions to the FDA they are told they are not taking complaints.  If you
want to show a decrease this is a good way to do it, don't count the
complaints that come in by mail, tell people you're not taking complaints,
and throw out what you have!  Many anti-aspartame organizations that have
existed since aspartame was approved have admitted having hotlines that
receive thousands of complaints.  This is why we constantly tell people to
send us their story.  It is estimated that 5 out of every 7 people on
aspartame already have the symptoms or some disease.  I know if I'm in a
crowd and talk to 10 people on aspartame at least 6 will have problems
from it!

Now, here is the story Mark Gold just sent me, and he also sent me a lot
of up-dates on his web page:

I know everyone has gotten a lot of information on aspartame in one day,
so I'll sign off for the night.  

And again, thank you Mark.

To get more information on aspartame, email as follows:
Subject: sendme help   
The subject line must be typed exactly like the above line.
Betty Martini             1.  Take the 60-day No-Aspartame test
Mission Possible                 and send us your case history.
PO Box 28098              2.  Tell your doctor and your friends.
Atlanta GA  30358         3.  Return Aspar-Poisoned foods to the store. 
USA                           (Nutrasweet(tm), Equal(tm), Spoonful(tm), etc)

We are dedicated to the proposition that we will not be satisfied until death 
and disability are no longer considered an acceptable cost of business.

On Sun, 12 Jan 1997, Mark Gold wrote:

>                FDA resisted proposals to test aspartame
>  Greg Gordon
>  Star Tribune
>  November 22, 1996
> WASHINGTON, D.C. -- Food and Drug Administration 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 1980s and 1994, 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.
> Now, after a scientific paper by researchers at Washington University of
> St. Louis has rekindled fears that aspartame may cause deadly brain
> tumors, some present and former NIEHS officials are criticizing the FDA
> for using its influence to delay research that could have settled some
> or all of the safety issues. Amid calls from consumer groups for more
> testing, NIEHS managers said they may reconsider their decision.
> FDA officials, including Commissioner David Kessler, insist that
> aspartame is safe and needs no more testing.
> Alan Rulis, who oversees the approval of food additives at the agency,
> said this week that the FDA would need "a scientific basis" to endorse
> further research.
> Two NIEHS toxicologists, James Huff and June Dunnick, said they sought
> independent studies not because they have data suggesting NutraSweet
> causes health problems, but because of the nagging safety concerns about
> one of the most pervasive food additives.
> Disclosure that federal scientists outside the FDA sought more studies
> adds a new twist to a long-running controversy over the manner in which
> the agency approved the popular, low-calorie sweetener in 1981, expanded
> its uses in 1983 and defended its safety over the last 15 years.
> NIEHS officials say the FDA's resistance effectively prevented
> government research that might have resolved conflicts between scores of
> industry-funded studies, which have found the sweetener to be safe, and
> dozens of independent studies that have raised health concerns.
> Deputy FDA Commissioner Michael Friedman earlier this month, in
> challenging the scientific soundness of the latest published paper
> suggesting the sweetener may cause brain tumors, said the agency has
> gone to great lengths to review all animal data on aspartame. Indeed, he
> said, scientists at the Toxicology Program did not feel there was
> "sufficient evidence" to warrant further study. He did not mention that
> the FDA, which helps fund the toxicology program, repeatedly opposed
> such studies.
> "It's a wonderful way to ensure that it isn't tested," said David Rall,
> who retired in 1990 after directing NIEHS and overseeing the National
> Toxicology Program for 19 years. "Discourage the testing group from
> testing it and then say it's safe."
> Widespread consumption
> Rall said consumption of aspartame has "vastly exceeded expectations
> when the original toxicology was done" in the early 1970s by
> Illinois-based G.D. Searle & Co., which owned the patent. (Searle was
> purchased in 1985 by the St. Louis-based Monsanto Co., which now sells
> close to $1 billion in NutraSweet annually through a subsidiary, the
> NutraSweet Kelco Co.)
> Rall said that "any compound that is that widely used needs to be
> retested with modern methods every once in awhile." He said scientists
> have much better technology and know much more about how to detect
> cancer than they did in the 1970s.
> Like many other scientists, Rall said he is skeptical of the newly
> published analysis of brain tumor data by researchers at Washington
> University of St. Louis. But he called "preposterous" the assertion this
> week by Gerald Moser, NutraSweet Kelco's senior medical consultant, that
> it would be impossible for the sweetener to cause cancer.
> Richard Nelson, a spokesman for NutraSweet Kelco, said the firm feels
> "the more than 200 tests that have been done prior to and subsequent to
> the approval of aspartame more than adequately demonstrate the safety of
> the ingredient."
> If the FDA wanted more tests, he said, "we'd be the first ones in line
> to make sure those tests are accomplished," although the company might
> propose a testing laboratory different from the Toxicology Program's.
> Each year, the National Toxicology Program at Research Triangle Park,
> N.C., begins multiyear studies on seven to eight substances selected
> from scores of "nominations" by committees of scientists from about a
> dozen federal agencies. Decisions are difficult because cancer studies
> alone cost $1.5 million to $4 million and take four years or more, and
> the program's annual budget is limited to $80 million, said George
> Lucier, director of NIEHS' component of the Toxicology Program.
> Before formally proposing a study to the full committee, NIEHS officials
> customarily consult with the agency that regulates the nominated
> substance to gauge its interest in further research, Lucier said. The
> agency's position is given great weight, he said.
> Lucier's deputy, John Bucher, said at least two other individuals from
> outside the agency, whom he did not identify, also nominated aspartame
> for further research. He said when approached on each of the half-dozen
> occasions when aspartame was nominated, FDA officials said they felt no
> further research was needed. NIEHS officials then put off the proposals
> without presenting them to the interagency committees, he said.
> Rall said he personally took one of the proposals to the FDA but that
> Sanford Miller, then chief of the Center for Food Safety and Applied
> Nutrition, asked him "to put it off a year or two."
> Huff said that in his 1994 nomination, he planned to seek complete life
> cycle animal testing for all possible toxic effects of aspartame, from
> birth through mating, pregnancy and weaning "to mimic the human
> experience."
> "The FDA has a ton of adverse reaction reports" from the public, Huff
> said. "They downplay it. They just say, 'Well, it's idiosyncratic.' . .
> I think it's real."
> Health complaints
> FDA officials said that, since 1981, about 8,000 consumers have
> complained to the agency that the sweetener has caused them physical
> ailments, including headaches, nausea, vision problems and seizures.
> Scientists consider such reports anecdotal and not proof of a causal
> relationship.
> Huff said that the number of reports is worrisome, though, because "if
> 100 people have a headache after chewing NutraSweet gum, only one's
> going to report it."
> The FDA's Rulis, who was not involved in the approval of aspartame, said
> the agency's reluctance to support more studies must be considered in
> full context: It uses computer databases to track the continuing safety
> of thousands of food additive uses. Mere concern about a product, he
> said, "cannot be allowed to drive a decision about a safety study.
> "What has to drive it is the scientific basis for that concern. That's
> what we're looking for here and what we don't see in this case."
> David Hattan, who heads a "Health Effects Evaluation" unit at the FDA's
> Center for Food Safety , said NIEHS officials never pushed hard for
> further studies but merely sought the agency's judgments as to whether
> more testing is needed.
> Dunnick, who joined Huff in urging a study in 1994 and also nominated
> the sweetener in the late 1980s, said she did so because women expressed
> concerns about the sweetener's safety during a National Institutes of
> Health survey.
> Aside from the consumer complaints, a major reason for the debate over
> aspartame has been a controversy over Searle's early laboratory studies.
> Two FDA investigative task forces issued scathing reports in the
> mid-1970s on the quality of the company's research. In 1976, the FDA's
> general counsel requested a federal grand jury investigation of the
> company because of alleged irregularities in its laboratory. (Such an
> investigation was never undertaken.) In 1980, a Public Board of Inquiry
> that was asked to review scientific data on aspartame voted 3-0 to keep
> it off the market pending further studies on the brain cancer issue.
> In the first months of the Reagan administration, new FDA Commissioner
> Arthur Hull Hayes said a late-arriving industry study cleared up the
> cancer questions. He overturned the Board of Inquiry and put NutraSweet
> on the market.
> NutraSweet Kelco has said subsequent studies have confirmed the
> integrity of Searle's original research.
> Copyright 1996 Star Tribune. All rights reserved.