CENTER FOR SCIENCE IN THE PUBLIC INTEREST PART 1

Posted: 21 October 2005

We thank Barbara Metzler, Mission Possible New Jersey, for scanning in a report written by Michael Jacobson of CSPI in l985. See below.

Jacobson tells a different story today as he mouths off on Fox News that soda should have warning labels - drink diet soda. Since aspartame was approved in carbonated drinks in l983 these diet drinks have contained aspartame. Notice below his full knowledge of the dangers of this neurotoxin, not to mention he has been written for years about it. On Fox News Dr. Isadore Rosenfeld discussed the new Italian Study on how aspartame causes leukemia and lymphoma. And a new study has been released linking diet drinks to obesity. (Sharon Fowler's study from the University of Texas on WebMD.) Aspartame also can precipitate diabetes, simulates and aggravates diabetic retinopathy and neuropathy and interacts with insulin. Michael Jacobson knows all this but says because of obesity and diabetes people should use diet soda. So with full knowledge he knows by saying that consumer can become obese and get diabetes because of using aspartame. Jacobson should be flooded with emails on how he is stumbling the public with full knowledge. Fox News should never interview him again and give a retraction. Also, with Splenda also being used one must remember it is a chlorocarbon poison (The Lethal Science of Splenda - http://www.wnho.net ). Aspartame is a chemical hypersensitization agent so those getting on to another toxin from aspartame can react.

Michael Jacobson's email is cspi@cspinet.org

Dr. Betty Martini
Founder, Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
http://www.dorway.com
http://www.wnho.net

Subject: From 1985 - CSPI

FROM The Complete Eater's Digest and Nutrition Scoreboard
By Michael F. Jacobson

Anchor Press/Doubleday
Garden City, NY 1985

Aspartame Sensitive individuals; Pregnant women: Avoid
Others: ?

The history of artificial sweeteners is a grim one:

• Dulcin; banned in 1950, because it caused liver cancer;
• Cyclamate: banned in 1970, because it appeared to promote cancer and mutations;
• Saccharin: ban proposed in 1977, because it increased the risk of bladder cancer.

The latest artificial sweetener to move into the spotlight is aspartame, which is marketed under the names Equal and NutraSweet and is about 180 times sweeter than sugar. Thus, a tiny amount can replace a very large quantity of sugar. Aspartame has one tenth the number of calories as an amount of sugar with equal sweetening power.

Like saccharin and many other chemicals, aspartame's sweetness was discovered serendipitously, in this case by a Searle drug company scientist in 1965. Aspartame is synthesized from two amino acids that occur naturally in food, phenylalanine and aspartic acid, and methanol (wood alcohol). Aspartame itself does not occur in nature.

FDA first approved aspartame on July 24, 1981, for use as a tabletop sweetener (the little packets) and in breakfast cereals, powdered beverage mixes, and other dry packaged foods. Two years later, FDA approved the use of aspartame in soft drinks, by far the biggest and most lucrative market ' for the additive. Aspartame cannot be used in foods that are baked or otherwise heated, because it loses its sweetness as it gradually breaks down to form diketopiperazinc (DKP) or to form the amino acids of which it is composed. However, it can be added shortly before such foods are finished cooking. Packages of the artificial sweetener bear notices advising, "Not to be used in cooking or baking."

At first glance aspartame, which is advertised as "the good stuff," might appear as harmless as any other source of amino acids such as meat, eggs, or beans but aspartame has been the focus of a vigorous controversy going back to 1973, when Searle first petitioned FDA to permit its use. A basic difference between aspartame and food sources of amino acids is that when we eat meat or beans the protein is digested slowly, the amino acids are released gradually, and small amounts of a wide variety of amino acids are present. But when we eat aspartame, our body is exposed to a quick burst of just two amino acids.

One undisputed problem relates to the phenylalanine portion of the sweetener. One out of 20,000 babies has the genetic disease called phenylketonuria (PKU) and cannot metabolize this amino acid. Phenylalanine rises to toxic levels and causes mental retardation. All newborn babies are tested for PKU, and sufferers are put on a special diet without phenylalanine. These babies also have to be protected from aspartame. FDA requires that all packaged foods containing aspartame bear a notice saying: "PHENYLKETONURICS: CONTAINS PHENYLALANINE" Foods served at restaurants and cafeterias are not covered by this requirement.

A more subtle question concerns people who do not have! PKU themselves, but unknowingly carry the genetic trait (about 1 percent of the population). A woman who carried the PKU gene could give birth to a baby with the disease.

Some scientists warn that if such women consumed large quantities of aspartame or other sources of phenylalanine during pregnancy; their babies might be born mentally retarded. FDA scientists, however disagree. According to then FDA Commissioner Arthur Hayes, aspartame appears to present no greater hazard than common protein-rich foods considered essential for proper nutrition." This contention is hotly disputed, though, especially in light of the proliferation of aspartame-containing foods. In July 1984, the American Academy of Pediatrics' Committee on Genetics and Environmental Hazards expressed concern about aspartame consumption among young children and pregnant women. The committee concluded, "insufficient information is available to indicate whether high, but nonabuse level, intake by certain individuals is likely to cause harm.

The controversy over aspartame's safety is much broader than the PKU issue. The debate was initially sparked in 1974 by Washington attorney James S. Turner and Dr. John Olney, a Washington University scientist. Olney had previously shown that MSG (monosodium glutamate, a common flavor enhancer), might cause brain damage in babies. Olney's statistics helped force MSG out of baby foods. Aspartame contains aspartic acid, which is chemically quite similar to glutamate. Olney charged that aspartame, along with glutamate and aspartic acid from traditional foods, could gang up to cause brain lesions. He didn't have proof of this, but he and Turner felt that the evidence was sufficiently suggestive that aspartame could not be considered proven safe.

Before FDA ruled on Olney and Turner's charge, the agency itself became suspicious of the quality of Searle's animal experiments on many different chemicals. As writer Judith Randal related in a major story about aspartame in the Washington Past, an FDA task force reported-that "Searle made a number of deliberate decisions which seemingly were calculated to minimize the chances of discovering toxicity and, or, to allay FDA concern." FDA found major flaws in many of Searle's studies, including some on aspartame. Then FDA Commissionaire Alexander Schmidt refused to approve the sweetener and later told Randal that "Searle has been running a cruddy operation."

In addition to doctoring records, a Searle official sought to increase aspartame's chances of approval by inculcating in F DA officials a "subconscious spirit of participation" in the Searle studies. In January 1977, FDA General Counsel Richard Merrill wrote, "The FDA must. receive the truth, not psychological warfare." That statement was part of a thirty-three page letter to the Justice Department, in which Merrill requested a grand jury investigation into Searle's alleged violations of the law. The Justice Department denied the request, and, as grand jury rules dictate, never provided a public explanation.

With a grand jury ruled out, the next step in the aspartame saga was a review of fifteen out of eighty of Searle's studies. This review, conducted by a consulting firm called Universities Associated for Research and Education in Pathology (UAREP), was supposed to answer all the questions, but it was so narrowly focused that it proved of little value. It reviewed the pathology, but not the design, supervision, and conduct of the studies.

Turner blasted the UAREP review and persuaded FDA to appoint a precedent-setting public board of inquiry to examine the whole range of complaints about aspartame. The board of three scientists -- chosen jointly by FDA, Turner, and Searle -- was established in 1979. Ultimately, to the dismay of Turner and others, this committee, too, focused only on a limited number of issues, including Olney's charge about brain damage and another charge that aspartame caused brain tumors in laboratory animals. The board concluded in September 1980, that aspartame did not increase the risk of mental retardation or noncancerous brain lesions. Olney held his ground, however, arguing that the industry-sponsored studies were deficient and urging that new, independent tests be conducted. FDA sided with the board.

The cancer question arose from a feeding study in which aspartame was fed to rats. Ordinarily, brain tumors occur very rarely in laboratory rats. The board said that '`aspartame, at least when administered in the huge quantities employed in these studies, may contribute to the development of brain tumors" and urged that the tumor tests be repeated. Because of the possibility that aspartame caused brain tumors, the board said that aspartame should not be allowed in our food supply until further tests confirmed or refuted the study linking the sweetener to brain tumors.

FDA rejected the board of inquiry's conclusion concerning brain tumors, saying that the apparent increase in brain tumors was a statistical fluke. FDA said that the number of tumors occurring in the control (untreated) rats was uncharacteristically low and presented National Cancer Institute evidence in support of this notion. (Comparing the incidence of tumors in test animals to "historical" controls, rather than to the control animals used in the current study, is a potentially mischievous practice that can be very misleading if not done carefully and interpreted cautiously.) Also, a new rat study, completed after the board's review, was conducted by Ajinomoto, a Japanese marketer of aspartame. FDA said that this study did not show any evidence of harm. However, the new study was done on a different strain of rat and could not confirm or disprove the previous study.

In June 1985, a former high-ranking FDA toxicologist, Dr. Adrian Gross, charged that the research "has established beyond any reasonable doubt that aspartame is capable of inducing brain tumors in experimental animals." Yet another controversy centers on DKP, the breakdown product of aspartame.

One study indicated that DKP did not cause cancer. However, there was evidence that the DKP was not mixed in well with the rest of the rats' food. Thus, the rats may have eaten much less of the chemical than was intended. FDA's own scientists criticized the study sharply, but later FDA said that this was one loose end that would just have to be left dangling. FDA could have demanded that this and other dubious studies be repeated. Attorney Turner pointed out that Searle and FDA could have saved themselves a lot of grief and the public a lot of worry if they had only repeated the flawed studies years ago.

And so it was that after eight years of debate FDA approved aspartame, first for use in dry foods, then soft drinks. Days before FDA was going to approve aspartame for soft drinks, Richard Wurtman, a respected neuroendocrinologist at MIT, wrote a letter of objection. He acknowledged: that small amounts of aspartame were safe he even said he used the sweetener himself­but expressed concern about large amounts. He was particularly concerned that allowing aspartame in soft drinks would lead to excessive consumption by children. Wurtman told FDA that studies he had just completed raised the possibility that aspartame would alter levels of brain chemicals (neurotransmitters) and cause behavioral changes. His studies on rats suggested that aspartame could reduce levels of serotonin in the brain, especially when the artificial sweetener was consumed with carbohydrate-containing foods, such as potato chips or a cupcake. The FDA acknowledged a theoretical possibility of a problem, but said that without more evidence, it could not accept Wurtman's argument.

Food sciences professor Woodrow Monte, of Arizona State University, raised another objection. He pointed out that as aspartame is metabolized, methanol a poorly tested, toxic chemical, is released. Monte said that methanol might cause visual and nervous system problems. FDA rejected this contention, too, saying the amounts of methanol were trivial, and then gave aspartame its stamp of approval.

Several months after FDA approved aspartame in soft drinks, news media ran major stories about possible dangers of the additive, and hundreds of consumers wrote to Wurtman, FDA, Monte, and others. These consumers complained of such symptoms as dizziness, headaches, epileptic-like seizures, and menstruation problems. One Yale physician told me that after drinking a can of Diet Coke her "head felt like it was coming unscrewed." She had never experienced that sensation prior to drinking Diet Coke, and it never- recurred once she stopped drinking Diet Coke.

FDA and Searle continued to defend aspartame's safety, but FDA asked the Centers for Disease Control (CDC) to evaluate the consumer complaints. It was quite possible that even though the problems being reported had not been detected in any of the past studies, a small fraction of consumers was indeed experiencing serious problems. CDC's inquiry was doomed to be inconclusive, because. CDC used questionnaires rather than clinical experiments to investigate the complaints. It would have been so easy to invite individuals who believed they were sensitive to volunteer for a controlled experiment. The individuals would be given either small amounts of aspartame or a placebo and then monitored for several hours. Such a study could have determined once and for all whether aspartame caused these immediate reactions. CDC concluded that:

Although it may be that certain individuals have an unusual sensitivity to the product, these data do not provide evidence for the existence of serious, widespread, adverse health consequences attendant to the use of aspartame.

FDA said that it supported the COC findings and believed that "clinical studies may be useful" in resolving concerns about aspartame. Searle has undertaken such studies.

In early 1984, Turner and the Community Nutrition Institute (CNI) a nonprofit citizens' group, filed a law suit against FDA, hoping to force the agency to hold a comprehensive, public hearing that would at long last examine all the still-disputed issues. As of July 1985, the case was still wending its way through the courts.

As summer 1984 approached, the aspartame controversy heated up when Common Cause published an expose that found "such serious deficiencies in the Food and Drug Administration's process of approving aspartame that we are calling on Congress to begin its own investigation of this approval process immediately."

Aspartame's critics predicted that heavy soft drink consumption during the hot summer months would lead to an enormous number of new consumer complaints. However, those complaints never materialized. The relative silence provided some reassurance that aspartame was not causing many any adverse reactions. In Canada, where aspartame had been used since 1981, the Common Cause report acknowledged that few people had ever complained to health officials.

The aspartame controversy continued into 1985. Dr. Keith Connors, of Children's Hospital in Washington, D.C., has been investigating the behavioral effects of venous sweeteners. In February 1985, the New York Times reported that Dr. Connors "has studied two young children who suffer extreme agitation following doses of aspartame equivalent to the amount found in a six-ounce serving of Kool-Aid sweetened with NutraSweet. One of the children becomes so agitated he has to be restrained." The article also quoted a Searle executive who acknowledged that "a few people may be allergic or sensitive to it."

Aspartame poses difficult questions for government policy makers. Clearly, not all of the questions have been answered, and even FDA acknowledges that aspartame introduces some small risks. Ideally, more tests would have been conducted to replace the many flawed and disputed tests before the chemical was approved. As FDA Commissioner Hayes told Science magazine, "In the best of all possible worlds Searle would have conducted additional tests of its own. I wish they had, sure. On the other hand, I didn't feel there was justification for saying, okay, let's wait a few years." In the absence of commercial pressures, FDA probably would have demanded such tests. But such pressures do exist, and now millions of consumers are participating, unwillingly, in a giant new experiment.

The reason for Searle's desire to speed aspartame to market and keep it there is obvious when you examine recent sales records: and future sales prospects. Sales of aspartame, according to The Wall Street Journal, would total $600 million in 1984 -- half of Searle's total sales­and $1 billion in 1985. The market for tabletop sweeteners doubled since aspartame was introduced. A beverage industrial trade journal predicted that in l990 diet sodas would account for half of all soda sales, twice the current level. Searle's future is rosy, indeed, unless a judge forces its golden goose off the market or a scientist proves conclusively that the chemical is indeed dangerous.

Until further studies are conducted aspartame should be considered of questionable safety for most people, and risky to certain- individuals. If you believe you have experienced a problem after consuming the sweetener, you should simply avoid it. If you have not noticed any problem, modest amounts -- up to a few servings a day should not pose a significant risk. But, just to be on the safe side until the uncertainties are resolved, no one should be consuming five or ten aspartame packets or aspartame-sweetened sodas a day. Pregnant women and infants should avoid aspartame. Safety aside, aspartame probably isn't much of a weight-loss aid. Most-people who save a few calories by drinking a diet beverage will probably make up those calories by eating a few more bites of some other foods.