In 1965, James Schlatter, a chemist working for G.D. Searle and Company (henceforth Searle), accidentally discovered aspartame whilst working on an anti-ulcer drug. Sixteen years later, aspartame was deemed safe by the Food and Drug Administration (FDA) for human consumption. That’s been the party line every since.
Today, I want to follow aspartame’s tortuous path from discovery to legality. This strange tale, which includes political pull, iron triangles and the revolving door, raised many red flags for me. They led to me cutting the sweetener out of my diet several years before developing diabetes. I’ve known the broad outlines for some time, but I wanted to do more digging and share it with you. Fortunately, there are many people out there on the net who have done the heavy lifting already for us.
1965 to 1980
After the discovery of aspartame, and the fact that it was far sweeter than sugar, Searle took the decision to gain FDA approval for human consumption. Artificial sweeteners were a lucrative and growing industry with saccharine having topped the list for several decades. Searle carried out their own research on aspartame from 1965 onwards and submitted their findings for FDA approval in 1973.
The FDA concluded Searle’s studies were sloppily conducted but nevertheless accepted aspartame was safe for human consumption because the sweetener was based on two amino acids that were found in the body naturally. Aspartame was briefly deemed safe and found its way into food products. Despite the approval, from 1973 onwards several scientists continued to raise concerns about aspartame’s safety including Dr John Olney a respected neuroscientist. Eventually, aspartame was pulled from the shelves in 1977 until further FDA inquiries were carried out to guarantee the safety of the sweetener. Things got worse for Searle in the same year when the FDA’s “Bressler Report” was published. The report listed dozens of problems with the company’s study which fed various quantities of aspartame to albino rats. Some of the more interesting problems included:
- Control and treated animals were randomly distributed on the same rack.
- No ear clips or other methods of uniquely identifying each animal were used.
- Food jars were not individually identified, yet all the filled jars for a given housing group (control, low, mid, and high dose) were placed on a mobile cart, which was wheeled to the housing rack.
- Observation records indicated that animal A23LM was alive at week 88, dead from week 92 through week 104, alive at week108, and dead at week 112.
- We found approximately 82 discrepancies of one gram or more in the food intake when expressed in grams/day.
- We found approximately 40 errors of 5 or more grams in food intake when expressed in grams/kg./day.
- Most of our dosage calculations [of aspartame] differed from Searle’s dosage calculations by 10 or more mg., when the dosage is expressed as mg/kg/day.
- A total of 20 animals were excluded from the study due to excessive autolysis [Autolytic cell destruction is uncommon in living adult organisms and usually occurs in injured cells and dying tissue].
- Records indicated that animal F6HF, a high dose female, was found dead at 787 days of treatment and the gross pathology sheet reported a tissue mass [cancer] measuring 5.0 X 4.5 X 2.5 cm. The submission to FDA reported no tissue mass and the animal was excluded from the study due to marked autolysis.
- The methodology as referenced in the submission to FDA is incomplete and not always an accurate reflection of the methodology actually used in the study. The fact that more than one method was sometimes used for a particular assay during different times of the study was not indicated in the submission to FDA.
So in 1977, things did not look good for aspartame or for Searle’s bottom line. Jerome Bressler, who led the FDA investigation into Searle, concluded the following in his report to the United States Senate:
Because of the importance of this study, why wasn’t greater care taken? The study is highly questionable because of our findings. Why didn’t Searle, with their scientists, closely evaluate this, knowing fully well that the whole society, from the youngest to the elderly, from the sick to the unsick, everyone will have access to this product?
A follow up investigation tried to determine if Searle had purposely falsified data in order to get aspartame approved by the FDA. Because their original studies were so slipshod, the FDA could not determine any malfeasance. Nonetheless, the FDA held a board of inquiry in 1979 and determined that aspartame must not be approved for human consumption until further testing could be completed. It wasn’t just Searle’s sloppy research that led to this conclusion. In addition, the board of inquiry were concerned about two Searle studies: E33 and E70. What were the concerns:
In E33, 320 rats were fed aspartame. Compared to the control group, the rats exposed to the chemical suffered from a significantly higher number of brain tumors. E70 revealed abnormally high amounts of brain tumors in both the aspartame and control groups, leading the board to believe that both groups had exposure to the substance.
By 1980, things were dire for Searle. A sweetener that was quite possibly carcinogenic and an FDA that did not seem prepared to grant approval anytime soon. Searle needed a saviour. Amazingly, it already had one, in the form of a Washington insider and former (and future) politician. He had been hired in 1977 as Searle’s new CEO. That saviour would be one of the cheerleaders who brought us the invasion of Iraq in 2003. Enter Donald Rumsfeld.
Sykes, Morgan. 2015. “THE ASPARTAME CONTROVERSY OF 1981 the Hidden Truth Behind the Not-so-sweet Artificial Sweetene”. The Virginia Tech Undergraduate Historical Review 4. DOI: http://doi.org/10.21061/vtuhr.v4i0.33
“NutraSweet-Not So Neat,” Off Our Backs 14, no. 8 (1984): 8. http://www.jstor.org/stable/25794461.
John Olney, “Medicine Alumni Society: Alumni Interview,” The University of Iowa, accessed, February 16, 2014, http://www.healthcare.uiowa.edu/alumni/interviews/olney_john.html.
Stephen Chapman, “Can Rumsfeld Add Another Line To A Strong Resume?” Chicago Tribune, February 15, 1987, C3. http://articles.chicagotribune.com/1987-02-15/news/8701120628_1_donald-rumsfeld-white-house-secret-service.
Jerome Bressler, interview by Robert A. Tucker, History of the US Food and Drug Administration, April 23, 1999, http://www.fda.gov.
“Controversy Over New Sweetener,” Science News 116, no. 6 (1979): 103. http://www.jstor.org/stable/3964327.