Aspartame

[Pan]

I'll wait. And I hope your knee improves quickly.

[jat]

Gregory Gordon's comments:

"(Douglas) Park said that (Panel lawyer Joseph) Levitt hurried the panel to decide the issue. 'THe wanted to have the results yesterday,' he said. 'We really didn't have the time to do the in-depth interview 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 decsion 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 no directed to draft the approval memo, but did so as a 'tactical' step to break the team's weeks-lon 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, l981 aspartame was approved for use dry foods by FDA Commissioner of Inquiry and ignoring the law, Section 409 © (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, l982, 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 attatched to the Orphan Drug Act (an act which encourages the development of grugs for rare diseases) which midified the U.S. Patent las (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 ther 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 recieved a $1,ooo campaign contribution form the CEO of G.D. Searle before the amendment was proposed.

Representative Waxman recieved a $1,500 campaign contribution from the soft drink political action committee including $500 before the amendment was proosed. 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 pro-approval studies which led to the FDA investigations with any competence, aspartame could have been approved quickly like any other FDA approved food additive.

(If the studies had been done right, it is likely that aspartame would never been approved due to serious adverse reactions.)

Between 1979 and 1984, four FDA officials who took part in the aspartame approval process when 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):

( I have the names and associations if anyone wants)

Acting FDA Commissioner, Mark Movitch 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 won safety standards, they 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 postion as the Dean of New York Medical College and was hired as a consultant ($1,000 per day) with G.D. Searle's public relations firm, Burston Marsteller

(Gordon 1987, ppage 499 of US Senate 1987).

On July 8, l983, 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, l983, James Turner, Esq. filed a petition with the FDA on behalf of himself and Community Nutrition Institute objecting to the approval of aspartame (Federal Register 1984).

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 of 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 597 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 99degree C 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 abd September 21, 1984, G.D. Searle officials contributed to the campaign of ARIZONA House Majority Leader Burton Barr. The Committee to Reelcet Barr then gave campaign contributions to a number of state representatives (Don ALdridge, Karen Miills, Jan Breuer) who all eventually voted to the side of G.D. Searle (Gordon 1987, page 507 of US Senate 1987)

Dr. Woodrow Monte's petition for a hearing regarding baning 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).

1985 Dr. Richard Wurtman of MIT is quoted as saying that Dr. Gerald Gull, a G.D.

Searle Vice President, came to his laboratory and threatened to veto his funding from the Internatiional Life Sciences Institute (ILSI) after Wurtman quit his job as a G.D. Searle consultant and became a NutrSweet opponent (Gordon 1987, page 503 of US Senate 1987).

[jat]

Final History of Aspartame:

Dr. Woodrrow Monte filed for reconsideration of his petition for a hearing in Arizona. He was granted a hearing scheduled for April 1985 (Gordon 1987, page 507 of US Senate 1987).

In April 1985, in an unusual and secret maneuver, the Arizona legislature removed the text in a Toxic Waste Bill and used it to pass a bill which banned the regulation of FDA-approved food additives (Gordon 1987, page 508 of US SEnate 1987). THis bill scuttled the hearing that Dr. Monte had been promised.

On May 7, 1985, the U.S. Senate heard testimony telating to an amendment put forth by Senator Howard Metzenbaum requiring the quantity of aspartame be labelled (Congressional Record 1985a). It is nearly impossible for a person to determine what quantity of aspartame they are ingesting unless it is labeled. Senator Orrin Hatch of Utah led the fight (along with G.D. Searle) against labeling

amendment. The amendment was defeated. Those voting against the amendment included:

Abdnor, Armstrong, Baucus, Bentsen, Biden, Bingaman, Boren, Boschwitz, Bradley, Bumpers, Cochran, Cohen, D'Amato, Danforth, DeConcini, Denton, Dixon, Dole, Domenici, Durenberger, Evans, FOrd, Garn, DOle, Gorton, Gramm, Gassley, Hatch, Hawkins, Hecht, Heflin, Humphrey, Hollings, Heinz, Helms, Inouye, Kassebaum, Kasten, Laxalt, Leahy, Levin, Lugar, Mattingly, McClure, McConnel, Mitchell, Murkowski, Nickles, Nunn, Packwood, Pressler, Pryor, Quale, Riegle, ROth, Rudman, Sasser, Simpson, Stafford, Stevens, Symms, Thurmond, Tribe, Wallop, Warner, Wilson, Zorinsky.

Those voting for the amendment included:

Burdick, Byrd, Chafee, Chiles, Cranston, Dodd, Eagleton, Glenn, Harkin, Hart, Hatfield, Johnston, Kennedy, Kerry, Lautenberg, Long, Hatfield, Johnston, Kennedy, Kerry, Lautenberg, Long, Mathias, Matsunaga, Melcher, Metzenbaum, Moynihan, Pell, Proxmire, Rockefeller, Sarbanes, Simon, Spector.

On August 1, 1985, Senator Howard Metzenbaum of Ohio introduced a bill entitled "Aspartame Safety Act of 1985" which required quantity labelling of aspartame on food items and mandated that there be a moratorium on new uses of aspartame until independent tests could be conducted under the auspices of the National Institues of Health (Metzenbaum 1985). Testimony was submitted for the record. The bill was submitted to a Senate committee where it died.

After suffering a $28 million dollar loss in the previous year, selling off 30 subsidaries, and having a suit filed by 780 women that G.D. Searle sold out to the chemical company, Monsanto (Gordon 1987, page 509 of US senate 1987). Monsanto then created the NutraSweet Company as a subsidiary separate form G.D. Searle.

14,400,000 pounds of aspartame were consumed in the U.S. in 1985 (USDA 1988).

1986 Community Nutrition Institute (CNI) filed a lawsuit against the FDA in DIstrict Court claiming that the FDA did not follow proper procedure in approving aspartame for beverages and that they should have held a public hearing before giving final approval (Farber 1989,page 39). After the District Court dismissed their suit and the D.C. Circuit Court of Appeals denied their request for a hearing stating that they failed to "raise any material issues of fact that require the FDA to grant a hearing" CNI stated: ...where the holding of a public hearing is no longer a responsible part of the food additive process, the F.DA. and the appeals court have increased the likelihood that unsafe food additives will reach the market.

In July 1986, the U.S. General Accounting Office (GAO) published the results of an investigaton of five former government employees involved in the aspartame industry (GAO 1986). While these former employees' actions were not illegal, it is a good example of how the U.S. Government and especially the FDA "revolving door" helps certain powerful companies have near complete control over governmental actions. Government employees will give industry whatever it wants . Then many of these employees will be rewarded with high-paying industry jobs. Some of those people will then end up back in govenment in order to do more favors for their industry friends.

15,700,000 pounds of aspartame were consumed in the U.S. in 1986 (USDA 1988).

1987 The United Press reported on October 12, 1987 that more than 10 federal officials involved in the NutraSweet decision took jobs in the private sector linked to the aspartame industry (Gordon 1987, page 495 of US Senate 1987).

On November 3, l987 a hearing was held in a U.S. Senate Committee to address the issue of aspartame safety and labelling (US Senate 1987). Senator Orin Hatch successfully blocked any labelling requirements.

Former FDA investigator and Toxicologist Dr. Andrian Gross presented before the U.S. Senate in 1987 (Gross 1987b, page 11). Dr. Gross concludes:

"Although in their report the GAO expresses the view that the FDA 'followed its required process in approving aspartame (for marketing)' I would sharply disagree with such evaluation. Although the FDA may have gone through the motions ro it may have given the appearance of such a process being in place here, the people of this country expect and require a great deal more from that agency charged with protectng their public health:- in addition to mere facade or window-dressing on the part of the FDA< they require a thorough and scientifically based evaluation by the Agency on the safety of the products it regulates. Unfortunately this has clearly not been the case here. ANd without this kind of assurance, any such 'process' or dance represnets no more than a farce and a mockery of what is truly required."

*********************** ***********************************

I will finish after dinner tonight.

[jat]

An estimated 17,100,000 pounds of aspartame were consumed in the U.S. in 1987. NutraSweet stopped providing consumption data to the USDA after 1987.

1991 Nutra Sweet joined with its long-time partner, Ajinomoto Co. Inc. of Japan to begin building an aspartame manufacturing plant in Gravelines, France. (Monsanto 1991).

1992 NutraSweet signed agreements with the Coca-Cola CO. and PepsiCo Inc. "stipulating the Nutrasweer Company as their preferred supplier of aspartame (Monsanto 1992).

NutraSweet stated that one of their options for increases sales in the carbonated soft drink market is to prepare "Higher-concentration formulations that use more aspartame' (Monsanto 1992).

1994 NutraSweet introduced tabletop aspartame products to Mexico, Hungary, Uganda, Ecuador, Romania, Uruguay, Paraguay. (Monsanto 1994).

Aspartame's net sales outside of the U.S. accounts for 10 percent of all net sales (Monsanto 1994).

As detailed by investigative journalist Gregory Gordon (Gordon 1996):

"Between the early 1980's and 1994, scientists at the Natonal Institutes of Environmental Health Sciences (NIEHS) proposed at least four times that the government's leading program for toxicology research fund such studies."

"The government scientists said they wanted the National Toxicology Program to conduct animal studies to resolve questions about the sweetener's cancer risks"

"after each of these "nominations," NIEHS officials elected not to pursue the research at the urging of FDA officials, who said they were satisfied with industry-sponsored research that found no health risks."

1995 In a June 12, 1995 article which appeared in Food Chemical News, Thomas

Wilcox, the FDA epidemology branch chief was quoted as saying, "FDA has no further plans to continue to collect adverse reaction reports or monitor research periodically done on aspartame." (Food 1995).

Finished first part on the history.

[jat]

Here's some more recent studies on Aspartame. The significance is the number

of studies that have been done and the number of concerns. As you can see it

would take me a couple of days to research these papers in the library.

I have heard enough reports from people discussing problems associated with

Aspartame. One is a scientist who has done extensive research for the

Anthrax vaccine. My husbands experience is enough for me.

Ann Pharmacother 2001 June;35(6); 702-6 Relief of fibromyalgia symptoms following discontinuation of dietary excitotoxins. Smith JD, Terpening CM, Schmidt SO, Gums JG. Malcolm Randall Veterans Affairs Medical Center, Gainseville, Fl, USA

Dangerous Diet Drinks, Aspartame--Physiological effect. Memory. Psychology

Today, Mar/Apr 2001, Vol. 34 Issue 2, p30, 2/5p

Trocho,C et al 1998 "Formaldehyde Derived From Dietary Aspartame Vinds to

Tissue Components in vivo." Life Sciences, Vol. 63, No.5, pp 337 +

Headaches comprise 28.7 % of the aspartame toxicity reactions reported to the

U.S. Food and Drug Administration Adverse Reaction Monitoring System

(DHHS 1997).

Blumenthal, HJ.,D.A. Vance, 1997, "Chewing Gum Headaches," Headache, Volume 37, Number 10, pages 665-666.

Hail WL, Milward DJ, Rogers PJ et al Physiological mechanisms mediating aspartame-induced

satiety. Physiol Behav (United States), Apr 2003, 78 (4-5)p 557-62

Nakao H, Umebayashi C. Nakata M, et al Formaldehyde-induced shrinkage of rat

thymocytes. J Pharmacol Sci (Japan), Jan. 2003, 91(1)p63-6

Xiao D, Choi MM Aspartame optical biosensor with bienzyme-immobilized eggshell membrane and oxygen-sensitive optode membrane.

Anal Chem (United States), Feb. 15, 2002, 35 (2Pt 2) pS1-93

Saitoh H, Nakamura A. Kuwahara M. et al

Modified DNA aptamers against sweet agent aspartame.

Nucleic Acids Res Suppl (England), 2002, (2) p215-6

Oyama Y, Sakai H, Arata T, et al.

Cytotoxic effects of methanol, formaldehyde, and formate on dissociated rat

thermocytes; a possibility of aspartame toxicity.

Cell Biol Toxicol (Netherlands), 2002, 18(1) p43-50

Butchko HH, Stargel WW Aspartame, scientific evaluation in the postmarketing

period. Regul Toxicol Pharmacol (United States), Dec. 2001, 34(3) p.221-33

Newman LC, Lipton RB Migraine MLT-down; an unusual presentation of migraine in

patients with aspartame-triggered headaches. Headache (United States), Oct 2001, 41(9) p899-901

Kovatsi L, Tsouggas M

The effect of oral aspartame administration on the balance of magnesium in the rat. Magnes Res (England) Sept. 2001, 14, p189-94

La Buda CJ< Fuchs PN

A comparison of chronic aspartame exposure to aspirin on inflammation, hyperalgesia and open field activity following carrageenan-induced monoarthritis.

Life Sci (England), June 15 2001, 69(4) p443-54

Goerss AL< Wagner GC, Hill WL

Accute effects of aspartmae on aggression and neurochemistry of rats. Life Sci (England) Aug. 4 2000,67 (11)p1325-9

Meguro T. Kashiwagi T, Satow Y

Crystal structure of the low-humidity form of aspartame sweetener. J Prept Res (Denmanrk), Aug 2000, 56(2) p.97-104

da Silva LC, Carvalho TS, da Silva FB, et al. Aspartame loading test in PKU heterozygous individuals bearing severe and moderate mutations. Clin Genet (Denmark) July 2000, 58(1) p86-

La Buda CJ, Hale, RL Anxiety in mice following acute aspartame and ethanol exposure. Alcohol (United States) Jan. 2000, 20 (1) p69-74

Schwartz GR Aspartame and breast and other cancers. West J Med (United States), Nov-Dec. 1999, 171(5-6) p300-1

* I have about 10 more pages of studies if you get the idea *

I do not know what these scientific studies conclude. I have read a few- concluding

aspartame toxicity and health problems. And there are many pages on each

study.

* The condescending remarks here on this board, and no apology, has been

enough for me to quit posting on this board. We all have alot to face on a daily

basis, and I would reflect on your words how you made someone feel that day.

[Pan]

jat, I wish you wouldn't stop posting. I can only speak for myself: That I was waiting for you to present some more recent studies, which you have now done.

I think aspartame is noxious and avoid it like the plague. I just didn't have clear evidence that it was harmful. And when I looked at PubMed, the recent studies that came up showed positive and not negative effects from aspartame. That doesn't contradict your citations, of course, which are obviously based on much more research, but it is what I found.

But a side issue is that this has me concerned:

La Buda CJ< Fuchs PN

A comparison of chronic aspartame exposure to aspirin on inflammation, hyperalgesia and open field activity following carrageenan-induced monoarthritis.

Life Sci (England), June 15 2001, 69(4) p443-54

Carageenan can induce arthritis? (What's monoarthritis? One joint only is involved?) Personally, I'm more concerned about that than anything aspartame might do, because I avoid aspartame and don't avoid carageenan. Does anyone have anything more about this?

[chromedome]

I read an article recently (can't find the damn' thing now, of course, but I will...) on the influence of funding on the results of medical (and other scientific) studies.

Aspartame was used, in this article, as a classic example of the thesis. The authors of the piece surveyed the (extensive) literature available on PubMed and other resources. They sorted the studies that had been done according to whether or not they found potential health issues; resulting in a nearly 50/50 split.

Then they sorted the two groups of studies by source of funding. The correlation was almost perfect: studies funded by companies with a stake in Aspartame found no health issues; studies funded from other sources found a "significant likelihood" of health issues. They also had some things to say about Atkins, but this thread is already contentious enough...

I find aspartame to give me "cotton mouth," nothing more. My daughter gets migraines. My wife finds that her tongue and throat get swollen and puffy, and that she has trouble swallowing. This holds true regardless of whether she ingests the stuff in a beverage, candy, or cough syrup. My son has no sensitivity to it at all.

We don't have a whole lot of processed foods in my house, though, so this typically takes place when we're visiting somewhere...and my wife drinks only milk or bottled water when we're at a potluck.

[Pan]

Then they sorted the two groups of studies by source of funding. The correlation was almost perfect: studies funded by companies with a stake in Aspartame found no health issues; studies funded from other sources found a "significant likelihood" of health issues. They also had some things to say about Atkins, but this thread is already contentious enough...

Good plan, but please post about Atkins in an appropriate thread.

Also, if you could post a specific citation, that would be terrific.