In the 1970s, aspartame was having some serious troubles. Actually, aspartame almost got scrapped because it was causing brain tumors.
That’s right. Back then, everyone knew that aspartame caused brain tumors.
G.D. Searle was successful in getting their “competition” out of the way, but they couldn’t get a handle on the death and brain tumor issue surfacing and resurfacing in the research studies on aspartame.
They had a big problem.
By 1970, saccharin was being vigorously pushed as unsafe, and the FDA banned cyclamate.
The Director of the FDA Toxicological Services Center for Food Safety and Applied Nutrition, Robert Scheuplein stated, “The decision to ban cyclamate was more a matter of politics than science. Meetings were not held. Things were not pursued. Work was not done. The people who were involved at the time were inadequate to the job. ”
Dr. John Olney, Research Psychiatrist, Department of Psychiatry at The Washington School of Medicine, began his studies on the safety of aspartame. Concerned that this “ulcer drug turned sweetener” was not a healthy product for the open market, Olney’s suspicions were proven correct when his laboratory mice developed lesions in their brains from aspartame.
Dr. Olney informed G.D. Searle that the aspartic acid in aspartame caused holes to form in the brains of his test mice. Ann Reynolds, the same researcher hired by Searle to investigate Dr. Waisman’s findings in the 1960s, was again contracted by Searle to investigate Dr. Olney’s findings.
Reynolds confirmed Olney’s findings in a similar study. This didn’t stop Searle, nonetheless, and they continued to push aspartame as the latest and greatest diet sweetener.
G.D. Searle petitioned the FDA for approval to use aspartame in all foods. Olney and Washington DC attorney Jim Turner met with G.D. Searle representatives to discuss Olney’s research findings, but their safety concerns came to no avail.
FDA Commissioner Alexander Schmidt, M.D. approved aspartame as a food additive in dry foods only. Olney and Turner then met with FDA Commissioner Schmidt to discuss Dr. Olney’s findings. This time, their safety concerns got some attention.
A FDA Task Force was formed to investigate aspartame safety concerns. FDA Lead Investigator Philip Brodsky and FDA Toxicologist Adrian Gross, M.D headed the Task Force. Both were charged with examining the original test material submitted by Searle for both aspartame and their Copper-7 IUD.
After several months of investigations, the Task Force submitted a 15,000-page document with a summary of over 80 pages. They reported that the problems they found throughout the Searle studies revealed a pattern of conduct that “compromised the scientific integrity of the studies.”
The FDA concluded that many of Searle’s studies were questionable, and Commissioner Schmidt’s 1974 aspartame approval was rescinded.
As a result of the Task Force’s investigation results, the first Senate Subcommittee on Labor and Public Welfare hearing was called on April 8 to discuss the safety of aspartame and several other Searle drugs.
At this time, Tate & Lyle, a British sugar company, began searching for ways to blend sucrose (sugar) with laboratory chemicals, discovering sucralose (Splenda).
A five member FDA Task Force headed by FDA Inspector Jerome Bressler received 15 Searle aspartame studies to examine. Bressler discovered that some of the test animals had developed uterine tumors during the research studies, and determined that some of the blood tests had been tampered with. According to Bressler’s report, Searle claimed they experienced problems with their instruments, and, therefore, substituted the results of some studies with other test results.
A Rockville, Maryland firm, UAREP, examined 12 of the 15 Searle aspartame studies, and reported finding written accounts of brain tumors.
In January, FDA Chief Counsel Richard Merrill formally requested that U.S. Attorney Samuel Skinner conduct a Grand Jury investigation on the tests submitted to the FDA by G.D. Searle. The investigation was based on whether Searle “concealed material facts and made false statements in animal study reports concerning the safety of the drug aldactone and aspartame.”
At this time, the FDA cited two specific aspartame studies needing special attention. One was a primate study where the monkeys suffered seizures but were never given autopsies. The second was a toxicity study on hamsters.
Attorney Skinner removed himself from the case in March, accepting a position with the law firm Sidley and Austin, hired to defend Searle in these specific investigations.
William Conlon, Senior Assistant US Attorney, was appointed US Attorney. Conlon took no action on the aspartame case, and accepted a position with Sidley and Austin later that same year.
Thomas Sullivan was appointed US Attorney, and also took no action in the aspartame investigations.
The statute of limitations for a grand jury investigation to prosecute the case expired in December.
Donald Rumsfeld, former Congressman and Chief of Staff for the Ford Administration, was hired as G.D. Searle’s President. He immediately hired three government officials, John Robson, Robert Shapiro, and William Greener, Jr.
John Robson was hired as Executive Vice-president. He was a former lawyer with Sidley and Austin, and served as Chairman of the Civil Aeronautics Board, working with the US Department of Transportation.
Robert Shapiro was hired as Searle’s general counsel, and soon became Searle’s first Director of the NutraSweet Division. Shapiro was Robson’s special assistant at the US Department of Transportation.
William Greener, Jr. was hired as Searle’s chief spokesman. He was former spokesman for the Ford Administration.
Northeastern Illinois University, Department of Psychology, submitted a study on aspartame. They documented the following research results: reproductive dysfunction in both male and female test animals; endocrine dysfunction including the pituitary gland, the thyroid gland, the ovaries, and the testes; an increase in weight; and a decrease in locomotor function.
Aspartame safety proceedings were held at The National Academy of Sciences. Research was presented showing elevated blood phenylalanine levels affecting the fetuses of mothers who carried the PKU gene, which resulted in a lower IQ and a higher incidence of developmental abnormalities in the fetus.
US Attorney Tom Sullivan submitted a formal statement to the FDA stating his reasons for not prosecuting Searle on aldactone. He made no mention of aspartame.
Several independent studies on aspartame were performed. As reported in Science magazine, studies linked methanol (10 percent aspartame) to fetal alcohol syndrome and to diminished cognitive capacity in newborn rats.
The New England Journal of Medicine published a study showing a high incidence of birth defects as a result of elevated phenylalanine levels in PKU women exposed to phenylalanine (50 percent aspartame).
Dr. Daniel Azarnoff, head of G.D. Searle’s Research and Development Division, stated that rats eating the required amount of DKP (Diketopiperazine) in research studies had a statistically significant number of tumors in their wombs.
The FDA requested a review of the objections to aspartame approval. Routinely, Administrative Law Judges hold public hearings, but in this case, the FDA suggested a Public Board of Inquiry be assembled with three scientists as opposed to judges. The Board was impaneled, but that story begins in the 1980s … the subject for the next aspartame timeline article.
That was a rocky 10-years for a product that is supposedly safe, you think?