Just before Christmas I posted on an Italian study of the artificial sweetener aspartame. In this study researchers gave rats doses of aspartame equivalent to amounts regularly consumed by humans and found that the rats developed cancers at a greatly increased rate. One of the hallmarks of this study was that the rats were allowed to live out their normal lives whereas with other aspartame studies the rats were killed and examined for tumors at a human equivalent age of about 53. Critics claimed that terminating the studies early didn’t give the aspartame its chance to fully promote the formation of cancers. This new study overcame this problem and showed that the rats taking the aspartame really did develop many more tumors than those taking placebo. But there was a problem as I pointed out in my post that the authors of the study played down: namely that the rats taking the aspartame lived longer.
Today’s New York Times featured a long story about this same study on the front page of the business section that is well worth reading in its entirety. According to the article entitled “The Lowdown on Sweet?” various people and activist groups have interpreted the data from this study in a way that furthers their particular aims.
As I read through all the posturing and finger pointing, a couple of things jumped out at me.
First, the director of the study, Dr. Morando Soffritti, was reported by another researcher as refusing to allow outside pathologists to review the cancerous samples.
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.
What’s even worse as far as I’m concerned is the admission of a collaborating scientist that not all of the tumor slides were evaluated.
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.
These problems combined with the fact the aspartame rats lived longer than the control rats are enough as far as I’m concerned to raise serious issues with this study. I certainly don’t think there is evidence enough to cause any kind of panic over aspartame based on these findings.
But, if all the nefariousness the New York Times article states happened during the approval process for aspartame actually happend as reported, I do believe it warrants a closer look.
A 1976 report from an F.D.A. task force, for example, found that Searle’s [the manufacturer of aspartame] studies on aspartame and several of the company’s pharmaceutical drugs [the Times article doesn’t say if this complaint is aimed at aspartame or was a complaint about Searle’s research methods in general]were “poorly conceived, carelessly executed, or inaccurately analyzed or reported.” It cited what it called a lack of training by the scientists analyzing tissue samples, a “substantial” loss of information because of tissue decomposition and inadequate monitoring of feeding doses.
In response to the report, the F.D.A. asked the Justice Department to open a grand jury investigation into whether two of Searle’s aspartame studies had been falsified or were incomplete. In a 33-page letter in 1977, Richard A. Merrill, the F.D.A.’s chief counsel at the time, recommended to Samuel K. Skinner, then the United States attorney for the Northern District of Illinois, that a grand jury investigate the company, which was based in the Chicago suburb of Skokie, for “concealing material facts and making false statements in reports of animal studies conducted to establish the safety of the drug Aldactone and the food additive aspartame.”
A grand jury was never convened, however. Shortly after the letter was sent, Mr. Skinner left the Justice Department to join Sidley & Austin, a law firm that represented Searle. After 12 years at that firm, now Sidley, Austin, Brown & Wood, Mr. Skinner was appointed to be President George H. W. Bush’s transportation secretary; later he became his chief of staff. In 1978, a year and half after Mr. Skinner left the United States attorney’s office in Chicago, his deputy, William F. Conlon, also left to work at Sidley & Austin.
This is but one of several such incidents reported in the article. It certainly does makes one wonder.
Another section of this long article discusses another subject that I posted on a few months ago, namely the idea that studies tend to show whatever it is that whoever pays for the studies want them to show.
In an analysis of 166 articles published in medical journals from 1980 to 1985, Dr. Ralph G. Walton, a professor of psychiatry at Northeastern Ohio Universities College of Medicine found that all 74 studies that were financed by the industry attested to sweetener’s safety.
Of the 92 independently funded articles, 84 identified adverse health effects. “Whenever you have studies that were not funded by the industry, some sort of problem is identified,” said Dr. Walton, adding that he has not looked at studies performed since 1985. “It’s far too much for it to be a coincidence.”
Hmmm. Gotta watch the funding on those studies.
On a clinical note, the same Dr. Walton
has studied aspartame from a neurological perspective, said he had also seen problems from the sweetener firsthand. At Safe Harbor Behavioral Health, a mental health facility in Erie, Pa., where he is clinical director, Dr. Walton said he had observed that for many people with mood disorders, such as depression or bipolar disorder, aspartame exacerbates the condition. “For people with panic disorders, for instance, we’ve seen that when we eliminate aspartame, it’s much easier to control their illness,” he said. “The number of panic attacks goes down.”
In our clinical experience MD and I have seen a number of aspartame-consuming patients with these kinds of problems as well as some others. We’ve seen headaches, acute abdominal pain, and short term memory loss if my own short term memory is standing me in good stead. These problems resolved when the patients involved laid off the aspartame. I will be the first to admit that these are anecdotal findings with little clinical significance, but when you’ve seen them a few times and seen them resolve when aspartame is abandoned, it makes you wonder.
As per usual, the New York Times turned to its favorite nutritional activist Dr. Michael F. Jacobson, head of the Center for Science in the Public Interest (aka the misguided food police), for a comment. Dr. Jacobson opined that he didn’t think the Italian study was definitive, but that the aspartame situation should be reviewed carefully. Said he:
For a chemical that is used by hundreds of millions of people around the world, it should be absolutely safe. There shouldn’t be a cloud of doubt.
This is the only time to my knowledge that I have ever agreed 100 percent with Michael Jacobson. And that makes me worry.
Remember, you heard if here first.