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NKYKev · 02-12-2006, 11:23 PM

I found this article very disturbing. It actually doesn't mention several other problems, but it at least deals with the history of how it got approved and the fact that studies not paid for by the industry have been showing problems for years. For those who do not have a NY Times account, here is the full article.

February 12, 2006
The Lowdown on Sweet?
By MELANIE WARNER

WHEN Dr. Morando Soffritti, a cancer researcher in Bologna, Italy, saw the results of his team's seven-year study on aspartame, he knew he was about to be injected into a bitter controversy over this sweetener, one of the most contentiously debated substances ever added to foods and beverages.

Aspartame is sold under the brand names Nutra-Sweet and Equal and is found in such popular products as Diet Coke, Diet Pepsi, Diet Snapple and Sugar Free Kool-Aid. Hundreds of millions of people consume it worldwide. And Dr. Soffritti's study concluded that aspartame may cause the dreaded "c" word: cancer.

The research found that the sweetener was associated with unusually high rates of lymphomas, leukemias and other cancers in rats that had been given doses of it starting at what would be equivalent to four to five 20-ounce bottles of diet soda a day for a 150-pound person. The study, which involved 1,900 laboratory rats and cost $1 million, was conducted at the European Ramazzini Foundation of Oncology and Environmental Sciences, a nonprofit organization that studies cancer-causing substances; Dr. Soffritti is its scientific director.

The findings, first released last July, prompted a flurry of criticism from the Calorie Control Council, a trade group for makers of artificial sweeteners that has spent the last 25 years trying to quell fears about aspartame. It said Dr. Soffritti's study flew in the face of four earlier cancer studies that aspartame's creator, G. D. Searle & Company, had underwritten and used to persuade the Food and Drug Administration to approve it for human consumption. "Aspartame has been safely consumed for more than a quarter of a century and is one of the most thoroughly studied food additives," read one news release from the council.

At the same time, Dr. Soffritti's findings have energized a vociferous group of researchers, health advocates and others who say they are convinced that aspartame is a toxin associated with a variety of health troubles, including headaches, dizziness, blindness and seizures.

DR. SOFFRITTI, who oversees 180 scientists and researchers in 30 countries who collaborate on toxin research, says that since last July, he has been contacted by some of these critics, including a member of Parliament in Britain and a number of conspiracy theorists, some of whom say they have suffered from "aspartame poisoning" and filled Web pages with cloak-and-dagger speculation about why the F.D.A. approved aspartame for sale a quarter-century ago.

No regulatory agency has yet acted on Dr. Soffritti's findings, although Roger Williams, a member of Parliament, called for a ban on aspartame in Britain last December. Last month, the European Food Safety Authority, an advisory body for the European Commission, began to review 900 pages of data from Dr. Soffritti; the goal is to finish by May. A commission spokesman, Philip Tod, said it was too early to know what the next steps would be if the scientists reviewing the data concurred with Dr. Soffritti's findings.

In the United States, the Food and Drug Administration says it has also taken note of the study, which is available online (http://ehp.niehs.nih.gov/docs/2005/8711/abstract.html) and is scheduled to be published next month in a medical journal financed by the National Institutes of Health. F.D.A. officials say that they, too, intend to conduct a thorough review.

But both the F.D.A. and the European Commission have cautioned that there is no need for people to avoid aspartame. "We don't see any concerns at this stage," said George H. Pauli, associate director for science policy in the F.D.A.'s Office of Food Additive Safety. "We've gone through a humongous amount of data on aspartame over the years."

Putting restrictions on aspartame would come at a significant cost. Food companies and consumers around the world bought about $570 million worth of it last year. New regulatory action on aspartame would also jeopardize the billions of dollars worth of products sold with it. Already, in the United States, many companies are opting to use sucralose, or Splenda, in their new low-calorie products, in part because it is less controversial.

Lance Collins, chief executive of Fuze Beverage in Englewood Cliffs, N.J., said that safety concerns about aspartame were a "major contributing factor" in his decision to use sucralose in his tea and juice drinks. Sucralose, however, is made by under a patent by just one company, Tate & Lyle of London, and is in desperately short supply.

Dr. Soffritti, who has spent 28 years doing research on potential carcinogens, said he was trying to steer clear of the growing political maelstrom. But he added that he was concerned about the large numbers of people who use aspartame, particularly children and pregnant women. "If something is a carcinogen in animals," he said, "then it should not be added to food, especially if there are so many people that are going to be consuming it."

Lyn Nabors, executive vice president of the Calorie Control Council, said Dr. Soffritti's study was not valid because the rats used in it had been allowed to live longer than the two-year standard established by the United States government's National Toxicology Program. "It's difficult to determine if the cancers you find are due to something else," Ms. Nabors said. "Just as in humans, the rat's body slows down later in life, and the aging process causes all kinds of things."

But John R. Bucher, deputy director of environmental toxicology at the National Toxicology Program, the government's agency for research on toxic chemicals, called the design of the Ramazzini study "impressive" and "thorough," and said that he did not think the fact that rats were allowed to live until their natural deaths had skewed the results.

Dr. Jose Russo, director of the breast cancer and environmental research center at the Fox Chase Cancer Center in Philadelphia, says that lifetime studies are "ideal" but that they are not done often, partly because they are more expensive than limited-time tests. Dr. Russo, however, criticized the Ramazzini study for not allowing outside pathologists to analyze all of the tissue samples where cancerous tumors were found. "People need to see every tumor," he said.

Dr. Bucher of the National Toxicology Program said pathologists at the program, with which Ramazzini collaborates, looked at 70 tumor slides. But with the study producing over 9,000 tumor-containing slides, James Swenberg, professor of environmental science at the University of North Carolina at Chapel Hill, says that this falls short of standard practice.

While Dr. Soffritti's methods have drawn some criticism, the Ramazzini cancer lab, which is financed by private bank foundations, governments and 17,000 individual members, has earned considerable credibility since it was founded in 1971 for its pioneering research on chemicals. It was the first research body to do studies showing that vinyl chloride and the gasoline additive methyl tertiary-butyl ether, or M.T.B.E., are carcinogenic, research that eventually encouraged the United States to strictly regulate vinyl chloride and that led 21 states to ban M.T.B.E.

Dr. Soffritti said he was inspired to look at aspartame because of what he calls "inadequacies" in the cancer studies done by Searle in the 1970's. He said that those studies did not involve large-enough numbers of rats and did not allow them to live long enough to develop cancer.

02-12-2006, 11:23 PM
NKYKev Confirmed User Join Date: Jul 2005 Posts: 283	NY Times article on Aspartame I found this article very disturbing. It actually doesn't mention several other problems, but it at least deals with the history of how it got approved and the fact that studies not paid for by the industry have been showing problems for years. For those who do not have a NY Times account, here is the full article. February 12, 2006 The Lowdown on Sweet? By MELANIE WARNER WHEN Dr. Morando Soffritti, a cancer researcher in Bologna, Italy, saw the results of his team's seven-year study on aspartame, he knew he was about to be injected into a bitter controversy over this sweetener, one of the most contentiously debated substances ever added to foods and beverages. Aspartame is sold under the brand names Nutra-Sweet and Equal and is found in such popular products as Diet Coke, Diet Pepsi, Diet Snapple and Sugar Free Kool-Aid. Hundreds of millions of people consume it worldwide. And Dr. Soffritti's study concluded that aspartame may cause the dreaded "c" word: cancer. The research found that the sweetener was associated with unusually high rates of lymphomas, leukemias and other cancers in rats that had been given doses of it starting at what would be equivalent to four to five 20-ounce bottles of diet soda a day for a 150-pound person. The study, which involved 1,900 laboratory rats and cost $1 million, was conducted at the European Ramazzini Foundation of Oncology and Environmental Sciences, a nonprofit organization that studies cancer-causing substances; Dr. Soffritti is its scientific director. The findings, first released last July, prompted a flurry of criticism from the Calorie Control Council, a trade group for makers of artificial sweeteners that has spent the last 25 years trying to quell fears about aspartame. It said Dr. Soffritti's study flew in the face of four earlier cancer studies that aspartame's creator, G. D. Searle & Company, had underwritten and used to persuade the Food and Drug Administration to approve it for human consumption. "Aspartame has been safely consumed for more than a quarter of a century and is one of the most thoroughly studied food additives," read one news release from the council. At the same time, Dr. Soffritti's findings have energized a vociferous group of researchers, health advocates and others who say they are convinced that aspartame is a toxin associated with a variety of health troubles, including headaches, dizziness, blindness and seizures. DR. SOFFRITTI, who oversees 180 scientists and researchers in 30 countries who collaborate on toxin research, says that since last July, he has been contacted by some of these critics, including a member of Parliament in Britain and a number of conspiracy theorists, some of whom say they have suffered from "aspartame poisoning" and filled Web pages with cloak-and-dagger speculation about why the F.D.A. approved aspartame for sale a quarter-century ago. No regulatory agency has yet acted on Dr. Soffritti's findings, although Roger Williams, a member of Parliament, called for a ban on aspartame in Britain last December. Last month, the European Food Safety Authority, an advisory body for the European Commission, began to review 900 pages of data from Dr. Soffritti; the goal is to finish by May. A commission spokesman, Philip Tod, said it was too early to know what the next steps would be if the scientists reviewing the data concurred with Dr. Soffritti's findings. In the United States, the Food and Drug Administration says it has also taken note of the study, which is available online (http://ehp.niehs.nih.gov/docs/2005/8711/abstract.html) and is scheduled to be published next month in a medical journal financed by the National Institutes of Health. F.D.A. officials say that they, too, intend to conduct a thorough review. But both the F.D.A. and the European Commission have cautioned that there is no need for people to avoid aspartame. "We don't see any concerns at this stage," said George H. Pauli, associate director for science policy in the F.D.A.'s Office of Food Additive Safety. "We've gone through a humongous amount of data on aspartame over the years." Putting restrictions on aspartame would come at a significant cost. Food companies and consumers around the world bought about $570 million worth of it last year. New regulatory action on aspartame would also jeopardize the billions of dollars worth of products sold with it. Already, in the United States, many companies are opting to use sucralose, or Splenda, in their new low-calorie products, in part because it is less controversial. Lance Collins, chief executive of Fuze Beverage in Englewood Cliffs, N.J., said that safety concerns about aspartame were a "major contributing factor" in his decision to use sucralose in his tea and juice drinks. Sucralose, however, is made by under a patent by just one company, Tate & Lyle of London, and is in desperately short supply. Dr. Soffritti, who has spent 28 years doing research on potential carcinogens, said he was trying to steer clear of the growing political maelstrom. But he added that he was concerned about the large numbers of people who use aspartame, particularly children and pregnant women. "If something is a carcinogen in animals," he said, "then it should not be added to food, especially if there are so many people that are going to be consuming it." Lyn Nabors, executive vice president of the Calorie Control Council, said Dr. Soffritti's study was not valid because the rats used in it had been allowed to live longer than the two-year standard established by the United States government's National Toxicology Program. "It's difficult to determine if the cancers you find are due to something else," Ms. Nabors said. "Just as in humans, the rat's body slows down later in life, and the aging process causes all kinds of things." But John R. Bucher, deputy director of environmental toxicology at the National Toxicology Program, the government's agency for research on toxic chemicals, called the design of the Ramazzini study "impressive" and "thorough," and said that he did not think the fact that rats were allowed to live until their natural deaths had skewed the results. Dr. Jose Russo, director of the breast cancer and environmental research center at the Fox Chase Cancer Center in Philadelphia, says that lifetime studies are "ideal" but that they are not done often, partly because they are more expensive than limited-time tests. Dr. Russo, however, criticized the Ramazzini study for not allowing outside pathologists to analyze all of the tissue samples where cancerous tumors were found. "People need to see every tumor," he said. Dr. Bucher of the National Toxicology Program said pathologists at the program, with which Ramazzini collaborates, looked at 70 tumor slides. But with the study producing over 9,000 tumor-containing slides, James Swenberg, professor of environmental science at the University of North Carolina at Chapel Hill, says that this falls short of standard practice. While Dr. Soffritti's methods have drawn some criticism, the Ramazzini cancer lab, which is financed by private bank foundations, governments and 17,000 individual members, has earned considerable credibility since it was founded in 1971 for its pioneering research on chemicals. It was the first research body to do studies showing that vinyl chloride and the gasoline additive methyl tertiary-butyl ether, or M.T.B.E., are carcinogenic, research that eventually encouraged the United States to strictly regulate vinyl chloride and that led 21 states to ban M.T.B.E. Dr. Soffritti said he was inspired to look at aspartame because of what he calls "inadequacies" in the cancer studies done by Searle in the 1970's. He said that those studies did not involve large-enough numbers of rats and did not allow them to live long enough to develop cancer.