Aspartame, the sweetener used as an ingredient in approximately 6,000 consumer foods and beverages sold worldwide has a dark history of controversy, political influence, and questionable science. Let’s dive into the scandal that shaped one of the most consumed food additives in the world.
Discovered accidentally in 1965 by James Schlatter at G.D. Searle, aspartame was touted as a miracle low-calorie sweetener. But its approval process revealed troubling findings, including animal studies showing harmful effects.
The first big red flag? In 1977, 98 of 196 infant mice exposed to aspartame died during an FDA investigation. The findings, later published as the Bressler Report, highlighted severe data manipulation and negligence by Searle. The report was kept under seal by the FDA for 3 decades.
Searle’s studies showed poor methodology to say the least.
Here are a few of the relevant findings summarized from various documents describing the FDA Task Force Report:
Excising masses (tumors) from live animals, in some cases without histologic examination of the masses, in others without reporting them to the FDA." (Schmidt 1976c, page 4 of US Senate 1976b) Searle's representatives, when caught and questioned about these actions, stated that "these masses were in the head and neck areas and prevented the animals from feeding.
"Failure to report to the FDA all internal tumors present in the experimental rats, e.g., polypsin the uterus, ovary neoplasms as well as other lesions."
Instead of performing autopsies on rhesus monkeys that suffered seizures after being fed aspartame, the company had financed a new monkey seizure study with a different methodology that showed no problems."
Reporting animals as unavailable for necropsy when, in fact, records indicate that the animals were available but Searle choose not to purchase them.
Animals which had died were sometimes recorded as being alive and vice versa. These include approximately 20 instances of animals reported as dead and then reported as having vital signs normal again at subsequent observation periods.
Selecting statistical procedures which used a total number of animals as the denominator when only a portion of the animals were examined, thus reducing the significance of adverse effects.
G.D. Searle told the FDA that 12 lots of DKP were manufactured and tested in one study, yet only seven batches were actually made. Significant deviations from the protocols of several studies were noted which may have compromised the value of these studies. In at least one study, the Aspartame 52 weeks monkey study, the protocol was written after the study had been initiated.
In each study investigated, poor practices, inaccuracies, and discrepancies were noted in the antemortem phases which could compromise the study.
This resulted in the FDA’s Chief Counsel suggesting a grand jury investigation.
“The Food and Drug Administration has recommended to the Justice Department that a grand jury be convened in Illinois to investigate charges that a major drug firm, G. D. Searle & Company, has falsified data and reports submitted in connection with new drug applications.”
So how did this substance that is obviously unsuitable for human consumption gain FDA approval?
Enter Donald Rumsfeld, former U.S. Secretary of Defense who was hired as the CEO by Searle in 1977. Rumsfeld promised to use his political influence to push aspartame through regulatory hurdles and boy did he keep his promise.
“When Searle was absorbed by Monsanto in 1985, Donald Rumsfeld reportedly received a $12 million bonus, pretty big money in those days. Also, while at Searle, Rumsfeld was awarded Outstanding CEO in the Pharmaceutical Industry from the Wall Street Transcript (1980) and Financial World”
Authored by Josh Walkos via the Substack We The Free Follow on X: @JoshWalkos January 20th 2025