TCS Daily

You Dirty Rats!

By Elizabeth M. Whelan - May 30, 2006 12:00 AM

This past February, the New York Times ran a front page Business Section story noting that a Dr. Morando Soffritti, a cancer researcher "who has spent 28 years doing research on potential carcinogens" had concluded that the widely used artificial sweetener aspartame was likely to pose a human cancer risk.

Dr. Soffritti, whose research was sponsored by the European Ramazzini Foundation of Oncology and Environmental Sciences, was featured in the article smiling broadly, in a lab coat surrounded by his rodent subjects. His study was described by the Times as being the most thorough and long-lasting rodent testing project ever undertaken: "The Ramazzini study was conducted with 1,900 rats, as opposed to the 280 to 688 rodents used in Searle's [aspartame's manufacturer] studies, and the rats lived for up to three years instead of being sacrificed after two, which is the human equivalent of age 53." The Times noted, quoting Soffritti, "Cancer is a disease of the third part of if you truncate the experiments at 110 weeks and the rats are supposed to survive until 150 or 160 weeks, it means you avoid the development of cancer at the time when cancer would be starting to arise."

In other words, the newspaper of record was telling us, the Soffritti study was the Mother of All Rodent Studies. Yes, indeed, they imply, aspartame did cause cancer. And as the ultimate proof that the Foundation's results were credible and beyond dispute, the Times noted that the Ramazzini cancer lab was financed by "private bank foundations, governments, and 17,000 individual members." (Read: this lab was not a paid liar for industry.)

Aspartame -- those little blue packets with the trade name NutraSweet -- cause cancer! It was official!

Not so fast. Earlier this month, the European equivalent of the FDA said, "Never mind."

The European Food Safety Authority (EFSA) concluded that the Ramazzini assertion that aspartame was a carcinogen was not supported by data, and the agency saw no need to further review the safety of aspartame or to revise current recommendations on consumption levels. There were major flaws in the laboratory research, the EFSA concluded, noting that confounding factors, including chronic inflammation in the organs of the test animals, rendered the results invalid. And this in Europe, where the precautionary principle prevails, and where other food scares have pushed regulatory agencies into a very cautious stance.

What can we learn from this episode? Rodent tests are unreliable in many different respects. Even a study that was showcased as impeccable can be flawed. The Ramazzini aspartame-cancer study was evaluated and dismissed. But the U.S. Environmental Protection Agency (EPA) still cites Ramazzini data as "evidence," to take just one example, that the fuel additive MTBE causes cancer in rodents -- even though the protocol for those rodent tests on MTBE has been criticized for being as flawed as the aspartame study.

Cancer tests using high doses and performed on just one species are simply not useful in predicting human cancer risk. Animal tests in all human safety assessments are important, but the results should be interpreted cautiously to avoid the knee-jerk conclusion that "if it causes cancer in rodents it must cause cancer in people." Whatever animal tests are used as possible evidence of human hazard should be meticulously performed and able to survive peer review. The Ramazzini rodent cancer data on aspartame did not meet those criteria. Happily, the data concluding that aspartame was a "carcinogen" were rejected. The EPA should take notice and refrain from citing other Ramazzini rat cancer data, regardless of methodology, as justification for designating other chemicals as human "carcinogens."

The author is president of the American Council on Science and Health, which has published the book, America's War on "Carcinogens": Reassessing the Use of Animal Tests to Predict Human Cancer Risk



Oh - this explains a LOT
I moved to England about a year ago and immediately noticed that I couldn't get my favored sweetener in places that I would normally expect to find it. I complained at Starbucks - but I must admit I thought they didn't have it because they were too cheap.

I can buy a small dispenser in some supermarkets, and every once in awhile I find it on a table - but almost never. Like so many things here - they have scared people away from it.

So, you continue to see people getting more and more obese, something that we KNOW causes health problems. We don't need to test that one!

convenient model
Laboratory rats are a convenient testing model for studying potential good and bad effects on humans. They're small, cheap to breed and raise, and for some factors being studied - accurate.

However, rats are rodents, and humans are not. Rats normally eat their own ***** to get needed nutrients. I don't think humans do that.

Before you jump to believing that results from anything studied in rats means that the same thing will happen to humans, consider the above.

Aspartame and Cancer
I would ask how much more evidence there is for cancer for Saccharin. After all, it was effectively banned based on finding bladder cancer in male rats after feeding them massive amounts of the stuff.

Some where I saw it estimated that some 10% of the population is somehow sensitive to Aspartame, and I am clearly in that category, as are several other people I know. One found that it would cause him to black out. That is pretty scary for a pilot, as he still is (after swearing off Aspartame). The effects on me are similar, though less. It acts like a stimulant, much more potent to me than caffiene, and the crash off that is what I presume may have caused his blackouts.

There seems to be a double standard here, with Aspartame getting a pass when other substances, that appear much more benign to me, are banned.

Precautionary Principle
I think the politically correct types who have hijacked the precautionary principle would argue that, in this case, the right thing happened because no one got hurt by the aspartame (produced by the evil multinational company). The fact that the entire study was flawed is okay because this is a means to an end (and it ain't about safety!!) What happens next time, when instead of a sweetener, the compound being tested is a drug for cancer or diabetes or AIDS?? How many people need to die before these folks realize that doing nothing ISN'T always the safest course of action?

The same argument
applies to cyclamates in the 1970s. Trivial statistical findings supplemented by huge doses of the test substance far beyond concentrations ever found in the real world all add up to a substance ban. This sort of thing has been going on for a very long time.

A slight correction
The Precautionary Principle is not doing nothing; it calls for action to be taken in advance of science determining cause and effect because of the perceived degree of potential harm (without assessment of the degree of likelihood of that harm occurring).

That said, it has already happened. If you surf around on the web you will find details on a drug that was banned in the U.S. last year (?). It was the only truly effective treatment for narcolepsis (people uncontrollably falling asleep in the middle of the day). All that banned it was a slight association with cancer, but my memory may be failing me here. Since only about 50,000 Americans were highly adversely affected by the ban, no one cared.

Want more? Try the DDT ban, which has resulted in more deaths as a result of malaria infection than any human or natural event since the Black Death in the 14th century. But they were only black africans dying from malaria, not rich white american environmentalists. And it was a republican regime which did it, so this isn't just a left-right issue.

Doing nothing
It's important to understand that doing something and doing nothing are - really - two active options that FDA uses.

The "doing nothing" regulation is really used at FDA. When FDA employees believe that if they were to approve a drug/medical device that is later recalled from the market, that the decision to market that product may be a career-ending (at the FDA) move.

"FDA-think" says: it is far better for the FDA [disregard the patient's need] to never approve the drug/device in the first place.

shifting attention away from aspartame's real danger
The discussion about cancer and aspartame might be a diversion tactic. Aspartame probably doesn't cause cancer, but it probably does cause other health problems.

When I was a kid, I thought cancer was the only illness that toxic substances cause. Similarly, many news stories and discussions showing strong evidence that aspartame doesn't cause cancer, such leads people to believe that aspartame is safe. It might be the "truth" that aspartame doesn't cause cancer, but it is not the "whole truth" about aspartame's toxic effects on the body.

Another excellent, scientific-based article including a personal (non-scientific) report of a bad aspartame reaction at

Best wishes,

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