Dr. Nauta stated that he would have "definately" considered other tests and factors if he had known that aspartame was planned for use in soft drinks (Graves 1984, page S5503 of Congressional Record 1985a).
1980
The Public Board Of Inquiry voted unanimously to reject the use of aspartame until additional studies on aspartame's potential to cause brain tumors could be done. The PBOI was particularly concerned about experiment E33/34 where 320 rats received aspartame and a much higher percentage of animals in the aspartame group developed tumors than in the control group (Brannigan 1983, page 196). In addition, the PBOI was concerned about experiment E70 where 80 rats received aspartame. Both the aspartame group and the control group had an unusually high number of tumors, leading one to suspect that both groups were actually given aspartame (Federal Register 1981).
The PBOI did not believe that aspartic acid presented a neurotoxic hazard. Yet, Dr. Olney pointed out that (Olney 1987, page 3):
"[Dr. Young had a] lack of qualification" and that
he "based his decision on a consideration of
[aspartic acid] alone without regard to the real
issue, i.e., is it safe to add [aspartic acid] to
the large amounts of [glutamic acid/MSG] that are
already adultering the food supply?"
In addition, the "conservative" safety plasma level of aspartic acid used by Dr. Young was the level at which half the animals developed brain damage (Brannigan 1983, page 197). These errors by Dr. Young throw the question of safety of aspartic acid as part of aspartame into doubt. We will address this issue in more detail in a later section.
1981
On January 21, 1981, the day after Ronald Reagan takes office as U.S. President, G.D. Searle reapplied for the approval of aspartame. G.D. Searle submits several new studies along with their application. It was believed that Reagan would certainly replace Jere Goyan, the FDA Comissioner. G.D. Searle president, Donald Rumsfeld's connections to the Republican party were also thought to play a part in Searle's decision to reapply for aspartame's approval on the day after Ronald Reagan was inaugurated (Gordon 1987, page 499 of US Senate 1987).
According to a former G.D. Searle salesperson, Patty Wood- Allott, G.D. Searle president, Donald Rumsfeld told his salesforce that, if necessary, "he would call in all his markers and that no matter what, he would see to it that aspartame would be approved that year." (Gordon 1987, page 499 of US Senate 1987)
In March of 1981, a 5-member panel of scientists was established by the FDA Commissioner Jere Goyan to review the issues raised by the PBOI (Gordon 1987, page 498 of US Senate 1987; Mullarkey 1994b, page 8).
In April 1981, Arthur Hull Hayes, Jr. was appointed FDA Commissioner by Ronald Reagan (Graves 1984, page S5502 of Congressional Record 1985a).
On May 18, 1981, three of the scientists in the 5-member panel sent a letter to the panel lawyer, Joseph Levitt discussing their concerns about aspartame. Those three scientists were Satva Dubey (FDA Chief of Statistical Evaluation Branch), Douglas Park (Staff Science Advisor), and Robert Condon (Veterinary Medicine). Dubey thought that the brain tumor data was so "worrisome" in one study that he could not recommend approval of aspartame (Gordon 1987, page 495 of US Senate 1987). In another study, Dubey said that key data appeared to have been altered (Gordon 1987, page 499 of US Senate 1987).
In his UPI Investigation, Gregory Gordon went on to describe the unusual events that followed (Gordon 1987, page 499 of US Senate 1987):
"[Douglas] Park said that [panel lawyer Joseph]
Levitt hurried the panel to decide the issue.
'They wanted to have the results yesterday,' he
said. 'We really didn't have the time to do the in-
depth review we wanted to do.'
"Park said Levitt met frequently with Hayes and
'was obviously getting the pressure to get a
resolution and a decision made.'
"With three of five scientists on the
commissioner's team opposing approval, it was
decided to bring in a toxicologist for his opinion
on isolated issues [Barry N. Rosloff]. Goyan said
if the decision were his, he never would have
enlarged the team. While the panel did not vote,
it ended up split 3-3.
"Levitt, who normally would have been expected to
draft an options paper spelling out scientific
evidence on key issues, took an unusual tack. He
circulated an approval recommendation and only
backed off when Dubey, Park, and Condon objected,
team members said. Levitt said he was not directed
to draft the approval memo, but did so as a
'tactical' step to break the team's weeks-long
impasse by forcing each scientist to state his
views. 'It worked, didn't it?' said Levitt, who
later was promoted to a post as an executive
assistant to the FDA Commissioner."
On July 18, 1981 aspartame was approved for use dry foods by FDA Commissioner Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive (Federal Register 1981, Farber 1989, page 38). In an article in Common Cause Magazine, Florence Graves states that two FDA officials said that Arthur Hull Hayes, Jr. wanted to push aspartame approval through in order to signal reforms of the Reagan Administration. The "reasoning" behind the FDA Commissioner's decision will be discussed in a later section (Graves 1984, page S5497 of Congressional Record 1985a).
1982
On October 15, 1982, G.D. Searle petitioned the FDA for approval to use aspartame in soft drinks and children's vitamins (Gordon 1987, page 499 of US Senate 1987; Farber 1989, page 38)
On October 1, 1982 an amendment was attached to the Orphan Drug Act (an act which encourages the development of drugs for rare diseases) which modified the U.S. Patent law (Congressional Record 1982). The amendment extended the patent on only one product -- aspartame -- by 5 years, 10 months and 17 days (Gordon 1987, page 504 of US Senate 1987). The amendment did not mention aspartame or G.D. Searle by name and there was no debate or discussion on the amendment.
The amendment was proposed by Senator Howell Heflin, brought up for a vote by Senator Robert Byrd, and pushed through by Representative Henry Waxman and Orrin Hatch. G.D. Searle asked Senator Heflin to sponsor the amendment. Heflin received $9,000 in campaign donations shortly after this amendment was approved from G.D. Searle company executives and their wives. Senator Byrd had received a $1,000 campaign contribution from the CEO of G.D. Searle before the amendment was proposed. Representative Waxman received a $1,500 campaign contribution from the soft drink political action committee including $500 before the amendment was proposed. Senator Hatch received $2,500 from the soft drink political action committee prior to his reelection and $1,000 each from Daniel Searle, Wesley Dixon (Daniel Searle's brother-in-law), and William Searle (Gordon 1987, page 506 of US Senate 1987). Senator Hatch repeatedly blocked hearings looking into the safety of aspartame (Gordon 1987, page 506 of US Senate 1987).
It could be argued that the amendment to extend G.D. Searle's patent of aspartame rectified the lost marketing time caused by the FDA investigations. However, it was G.D. Searle's horrendous pre-approval studies which led to the FDA investigations and the delays. Had they performed the studies with any competance, aspartame could have been approved quickly like any other FDA-approved food additive.
(Actually, had the studies been done right, it is likely that aspartame would never been approved due to serious adverse reactions.) In addition, the amendment was applicable to one product and cannot be used similarly for other products.
Between 1979 and 1982, four FDA officials who took part in the aspartame approval process went through the FDA revolving door and took jobs in industries that are closely linked with the NutraSweet issue (Gordon 1987, page 498 of US Senate 1987):
1. Mike Taylor was an FDA lawyer who represented the FDA Bureau of Foods at the PBOI and was part of the team that prevented the quality and validity of G.D. Searle's studies from being considered (Gordon 1987, page 498 of US Senate 1987). 2. Sherwin Gardner was the Deputy FDA Commissioner in 1979. In July, 1974, he had signed the initial approval for aspartame's use in dry foods. (This initial approval was later block by objections from James Turner, Esq. and Dr. John Olney.) In December, 1979, Sherwin Gardner became a Vice President of Grocery Manufacturers of America, Inc. (GAO 1986). While Mr. Garden claims that he did not discuss aspartame is his 4 meetings with the FDA within a year of leaving that agency or his 20 meetings with the FDA between 1980 and 1986, the organization he worked for does deal directly with aspartame products. It is unlikely that he would have been rewarded with the job had he called for another delay in approval and proposed that safety tests be conducted independantly in order to protect the public. 3. Stuart Pape was the Health and Human Services (HHS) Chief Counsel for Foods from October 1976 to March 1979. He served as special assistant to the FDA Commissioner from March 1979 to December 1979. He participated in meetings and discussions on aspartame as well as representing the FDA at the PBOI. In December 1979, Mr. Pape was given a job by the law firm of Patton, Boggs, and Blow. This law firm provided counself to the National Soft Drink Association (NSDA). Mr. Pape and Howard R. Roberts of the NSDA (who formerly fought for approval of aspartame at the FDA) met with the FDA twice in 1983 where aspartame was discussed. In 1983, the NSDA inexplicably withdrew their objection to aspartame in diet beverage (GAO 1986). 4. Albert Kolbye was the Associate Director of the FDA Bureau of Foods for toxicology.
1983
Acting FDA Commissioner, Mark Novitch approved aspartame for use in carbonated beverages and carbonated beverage syrup bases (Federal Register 1983). FDA Commissioner, Arthur Hull Hayes was out of town the day that the approval was signed, but he worked closely with Mark Novitch on this issue (Gordon 1987, page 499 of US Senate 1987). Ignoring the FDA's own safety standards, the more than doubled the Acceptable Daily Intake (ADI) of aspartame from 20 mg/kg to 50 mg/kg (Metzenbaum 1985).
Shortly after the FDA approval for aspartame in carbonated beverages, FDA Commissioner, Arthur Hull Hayes left the FDA under charges of improprieties, took a a position as the Dean of New York Medical Collage and was hired as an a consultant ($1,000 per day) with G.D. Searle's public relations firm, Burson Marsteller (Gordon 1987, page 499 of US Senate 1987).
On July 8, 1983, Dr. Woodrow Monte, Director of the Science and Nutrition Laboratory at Arizona State University filed a petition objecting to the approval of aspartame based on possible serious adverse effects from the chronic intake of aspartame. Dr. Monte was especially concerned about the chronic intake of methanol (Federal Register 1984). Dr. Monte also filed a petition with the Arizona Department of Health Services to ban aspartame.
On July 8, 1983, James Turner, Esq. filed a peition with the FDA on behalf of himself and Community Nutrition Institute objecting to the approval of aspartame (Federal Register 1984).
Dr. Woodrow Monte, at the suggestion of his lawyer, invested $2,000 in G.D. Searle stock options in order to raise money for his costly legal battles against aspartame. He ended up losing $1,224. His purchasing of the "put options" caused some controversy. Dr. Monte was later accused of conflict-of- interest by G.D. Searle. Dr. Monte's lawyer had told him that he "didn't think there was anything wrong" with purchasing the options. A move that Dr. Monte later called a mistake. (Gordon 1987, page 508 of US Senate 1987)
On November 23, 1983, the FDA denied a request to put the approval on hold "because public interest did not require it." (Federal Register 1984).
1984
On February 17, 1984, the FDA denied Dr. Woodrow Monte and James Turner the opportunity to hold a safety hearing on questions raised in their petition (Federal Register 1984).
G.D. Searle sent a number lobbyists to the State of Arizona including Andrew Herwitz, Arizona Governor Babbitt's former Chief of Staff, Charles Pine, a prominent Arizona lobbyist, Roger Thies, a G.D. Searle lawyer, and David West, a G.D. Searle official (Gordon 1987, page 507 of US Senate 1987; Stoddard 1995a, page 17).
The State of Arizona DHS completed studies showing that aspartame in carbonated beverages can break down into free methanol (among other things) in 99oF temperatures. The amount of methanol which broke down concerned the DHS enough that a ban of aspartame was discussed (Gordon 1987, page 507 of US Senate 1987).
Between August 23, 1984 and September 21, 1984, G.D. Searle officials contributed to the campaign of Arizona House Majority Leader Burton Barr. The Committee to Reelect Barr then gave campaign contributions to a number of state representatives (Don Aldridge, Karen Miills, Jan Breuer) who all eventually voted of the side of G.D. Searle (Gordon 1987, page 507 of US Senate 1987).
Dr. Woodrow Monte's petition for a hearing regarding banning aspartame in Arizona was rejected (Gordon 1987, page 507 of US Senate 1987).
6,900,000 pounds of aspartame were consumed in the U.S. in 1984 (USDA 1988).