FDA to "review" recent Ramazzini aspartame cancer study

To date there are hundreds of cases where government regulators have betrayed consumers by approving drugs, chemicals, preservatives and additives of known toxicity as safe for consumption. It is a wonder why people tolerate a government that consciously exposes them to a comprehensive menu of scientifically and anecdotally-proven poisons. Soon it will become obvious that poisoning and killing people is just big business for special interest lobby groups with the political power to trump science in the public health and consumer safety game. Aspartame is now on the ropes because so many people have been informed that the FDA-approved artificial sweetener is actually a neurotoxic drug. Aspartame awareness, increasing by day, will expose the soft-white underbelly of an agency that should be named the Federal Death Administration. We need to press the advantage now that we have the scientific evidence of the dangerous side effects of aspartame.

By Don Harkins

The U.S. Food and Drug Administration (FDA) and the European Union’s Food Safety Authority (FSA) have announced their intention to "review" the recent European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) studies linking aspartame consumption to various forms of cancer. Both the FDA and the FSA maintain that, until they have reviewed the ERF test data, they will continue to promote the artificial sweetener aspartame as "safe."

In March, 2006, ERF released the results of a study entitled, First Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats (Soffritti, et al, March, 2006). Dr. Soffritti and his team exposed 1,800 rats to doses of aspartame over 36 months. The study revealed the development of a variety aspartame-induced cancers including leukemia, lymphomas and malignant brain tumors.

The flawlessly designed and carefully-conducted study showed that adult rats experienced dose-related increases of lymphomas/leukemias and malignant tumors—even at doses lower than the current acceptable daily intake (ADI) for humans (50 mg/kg body weight in the U.S.; 40 mg/kg body weight in the UK).

In April, 2007, ERF released the results of a second aspartame safety study, Lifespan Exposure to Low Doses of Aspartame Beginning During Prenatal Life Increases Cancer Effects in Rats (Soffritti, et al). The second ERF study was conducted on 400
Sprague-Dawley rats. Aspartame was added to the standard rat diet in quantities
of 100, 20, and 0 mg/Kg of body weight. Treatment 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.

Soffritti, et al, has scientifically concluded that aspartame is a "multipotential carcinogenic compound whose carcinogenic effects are evident even at a daily dose….much less than the current ADI [acceptable daily intake] for humans in Europe and the United States."

The ERF studies have withstood peer review and, last April, Dr. Soffritti received the prestigious Selikoff Award at New York’s Mt. Sinai School of Medicine for outstanding contributions to the identification of environmental and industrial carcinogens.

No surprises

The conclusions of ERF should come as no surprise to the FDA. Studies presented to the FDA beginning in the late 1960s documented aspartame’s link to brain, uterine, ovarian, testicular, mammary, pancreatic and thyroid tumors. The FDA, with full knowledge of aspartame’s toxicity and carcinogenicity, blocked approval for 16 years.

When the first ERF study was released last year, the FDA of today, which refuses to acknowledge scientifically valid agency concerns about aspartame safety established in the 70s and 80s, began conducting a damage control campaign by reviving a decade-old National Institutes of Health/American Association of Retired Persons (NIH/AARP) diet survey it claims "proves" aspartame safety. The survey contained 56 questions, of which only one could have produced "aspartame" as a response: What type of sweetener does the participant prefer to use in his coffee?

Though inconclusive at best, the FDA of today claims that the NIH/AARP dietary survey is "proof" that aspartame is safe.

Brief timeline of aspartame approval

Apparently unconcerned with the scientifically-confirmed health risks associated with aspartame, by February, 1973, the G.D. Searle company had filed a petition for FDA approval. In the process of petitioning the FDA for aspartame approval, Searle had spent $millions and had supplied the FDA with over 100 studies it claimed supported aspartame safety. Searle’s opinion that aspartame was "safe" was inconsistent with at least one Searle researcher who agreed with neuroscientist Dr. John Olney whose studies in 1971 had shown that aspartic acid (one of aspartame’s ingredients) caused holes in the brains of infant mice.

FDA toxicologist Dr. Jacqueline Verrett was one of the first agency scientists to review the aspartame safety test data submitted by Searle. In March, 1973, Dr. Verrett stated, "The information provided [by Searle] is inadequate to permit an evaluation of the potential toxicity of aspartame" and that further clinical tests were needed.

Regardless, the FDA approved aspartame for restricted use in dry foods on July 26, 1974.

Dr. Verrett later testified before a congressional committee chaired by the late Senator Howard Metzenbaum (D-Ohio) in 1987 that tests used as the basis of agency approval of aspartame were a "…disaster and should have been thrown out."

In August, 1974, consumer advocate attorney Jim Turner and Dr. Olney filed an objection to the approval and petitioned the FDA to reconsider. The petition prompted the FDA to suspend aspartame approval pending the outcome of an investigation into the lab practices at Searle; by March, 1976, the FDA concluded that Searle’s testing procedures were shoddy, full of inaccuracies and contained manipulated test data.

On January 10, 1977, the FDA formally requested that the U.S. Department of Justice convene a grand jury to seek indictments against Searle officers for "concealing material facts and making false statements" in aspartame safety tests submitted to the FDA.

The grand jury investigation was scuttled as lead U.S. Attorney Sam Skinner joined the private law firm representing Searle and D.C. insider Donald Rumsfeld became Searle CEO.

During this time, a team of FDA investigators led by Jerome Bressler published what has since become known as "The Bressler Report (1976)." The report found that 98 of 196 animals died during one of Searle’s studies and were not autopsied until upwards of a year later. Numerous other errors and inconsistencies with Searle safety studies as provided to the FDA were also discovered by the Bressler team. Among them, one rat was reported alive, then dead, then alive, then dead again.

The Bressler Report caused the FDA to convene a public board of inquiry (BPOI) in 1977. This report concluded that aspartame should NOT be approved pending further investigations of its relationship to causing brain tumors in animals. The BPOI determined that it (and the FDA) had "not been presented with proof of reasonable certainty that aspartame is safe as a food additive."

Against the recommendations of the BPOI, several FDA scientists and investigators, Arthur Hull Hayes, in one of his first official acts as FDA commissioner, reapproved the use of aspartame in dry goods July 15, 1981.

On October 15, 1982, Searle, with then former Secretary of Defense Rumsfeld as CEO, petitioned the FDA to approve the use of aspartame in beverages. Amid objections by the National Soft Drink Association, independent and FDA scientists, investigators and consumer advocates, the FDA approved aspartame for use in beverages.

In fall 1983, the first cans of aspartame-sweetened diet sodas were being sold in stores across America.

By then Hayes had left the FDA under a cloud of controversy and became a senior scientific consultant for Searle’s public relations firm Burson-Marsteller. To this day, Hayes will not answer probative questions about his decision to approve aspartame.

James Turner tells the entire tale in Sweet Misery: A Poisoned World.  It’s all on the public record

FDA list of aspartame-induced symptoms

Since aspartame’s approval, an estimated 80 percent of consumer product complaints fielded by the FDA are aspartame related. However, the FDA is currently denying the existence of the list of 92 symptoms of aspartame poisoning it published in 1995. The list includes seizures, coma, weight gain, dementia, blindness and death.

Poison is poison

As the numbers of aspartame poisoning cases accumulate, citizen petitions calling for the FDA to objectively review aspartame safety have been either denied or ignored by the FDA. Thousands of websites have been posting countless articles and passages from several books citing hundreds of studies confirming the aspartame/cancer/neurotoxicity links and have scientifically established the metabolic paths of ingested aspartame, which is 50 percent synthetic phenylalanine, 40 percent synthetic aspartic acid and 10 percent methanol. The known breakdown products—or metabolites—of aspartame include diketopiperazine, formaldehyde and methanol.

According to aspartame researcher Dr. Jim Bowen, "Every component of aspartame is toxic to the human body and every known metabolite of aspartame is of questioned or marked toxicity. Therefore, aspartame cannot be safe."

It has also been determined that aspartame interacts with other drugs and chemicals.

Ongoing violation of the Delaney Amendment

FDA toxicologist Dr. Adrian Gross testified before Congress on August 1, 1985, that at least one of Searle’s own aspartame safety 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 makes it illegal to allow any residues of cancer causing chemicals in foods.

Concluding his 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?"

To protect the manufacturers

The record shows that the FDA knew aspartame was never proven safe, that Searle defrauded the FDA in an attempt to prove it was safe and that FDA physicians, scientists and investigators charged with investigating aspartame knew it was toxic and carcinogenic. Yet the FDA ultimately gave Searle the green light to sell aspartame to the public as a safe, healthy, artificial, non-caloric sugar substitute.

Since aspartame was approved, scientifically-sound studies support and embellish the earlier studies about aspartame carcinogenicity and toxicity. Field experience has confirmed concerns voiced decades ago in anticipation of the impact a food and beverage supply laced with aspartame would have on public health.

So how does the FDA justify the continued approval and marketplace presence of aspartame? According to a February 12, 2006 article in The New York Times, the FDA has chosen not to ban aspartame because "…it would hurt the manufacturers economically."

The comment indicates that the FDA’s primary regulatory mission is to enhance the marketplace expectations of private corporations—not protect the health of consumers.

Concluding thoughts

The legal fallout from VIOXX and other FDA-approved drug scandals over the last several years has shown that agency officials routinely approve drugs and chemicals with known health risks. Yet, so far, neither FDA policymakers nor drug company officers are being held personally responsible or criminally liable for the pain and suffering (and even death) government-approved drugs and chemicals are causing millions of Americans to experience.

With regard to aspartame, the FDA has known all along the artificial sweetener is toxic and carcinogenic. At least 80 percent of the consumer complaints it has received since aspartame was approved are aspartame-related and now we have irrefutable science proving that aspartame is a multipotential carcinogen.

The FDA has not indicated when it will publish its review of the ERF aspartame study(s) test data. In the mean time, we get to wonder if the FDA’s review will confirm the agency’s original position that aspartame is carcinogenic and, therefore, not safe, or will the pending review reflect its current position that aspartame is safe?

The outcome will be interesting in either event because more and more people are becoming convinced that acute and chronic aspartame-induced illnesses are epidemic in the U.S. and throughout the world.