Good Science & Bad Science, Part 2

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"The doctor of the future will give no medicine, but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease."
- Thomas Edison

Cancer is a political problem more than it is a medical problem.

"Dr. Gross told Congress that aspartame violated the Delaney Amendment, which had forbid anything being put in food you knew would cause cancer, and this was because without a shadow of a doubt, aspartame can cause brain tumors."

"And if the FDA violates the law, who is left to protect the public?"

There is new research showing that a sugar called xylitol (pronounced zy-li-tol) can significantly improve oral health, improve calcium absorption, increase bone density and remineralize tooth enamel. Xylitol also helps prevent or eliminate gum disease, cavities, tooth loss, asthma, inner ear infections, chronic throat and sinus conditions, osteoporosis, and cardiovascular disease. Xylitol has only 2.4 calories per gram, compared to 4 calories per gram for sucrose sugar. Xylitol is digested slowly, making it easier on your pancreas and useful for diabetics. You can purchase xylitol in five pound bags and use it in cooking and for all purposes you would ordinarily use sugar. Due to the health benefits from consuming xylitol, we suggest that it is a good substitute for ordinary sugar.

The herb stevia is the best no-calorie sweetener. Available in health food stores.

Sugar feeds cancer.

 


Rich Murray: Simmons: Gold: Schiffman: Spiers:
aspartame toxicity 6.4.1 rmforall

N Engl J Med 1987 Nov 5;317(19):1181-5
Aspartame and susceptibility to headache.
Schiffman SS, Buckley CE 3d, Sampson HA,
Massey EW, Baraniuk JN, Follett JV, Warwick ZS
Department of Psychiatry, Duke University, Durham, N.C. 27710.

Dr. Susan S. Schiffman  Dept. of Psychiatry   Duke University
www.duke.edu  sss@acpub.duke.edu    919-684-3303, 660-5657.
She has over 100 obviously competent experimental studies and reviews since 1971 in PubMed. Her major field is the deterioration of smell and taste in seniors and AIDS patients from exposure to drugs, chemicals, and pollutants-- one wonders if she ever considered the effects of aspartame, since smell and taste impairment are known to result from exposure to aspartame or formaldehyde.

"Loss of taste" is one of 90 symptoms from many case reports of aspartame toxicity, summarized in: Department of Health and Human Services. "Report on All Adverse Reactions in the Adverse Reaction Monitoring System." (February 25 and 28, 1994).

Abstract (Schiffman et al, 1987):
We performed a double-blind crossover trial of challenges with 30 mg of aspartame per kilogram of body weight or placebo in 40 subjects who reported having headaches repeatedly after consuming products containing aspartame. The incidence rate of headache after aspartame (35 percent) was not significantly different from that after placebo (45 percent) (P less than 0.50). No serious reactions were observed, and the incidence of symptoms other than headache following aspartame was also equivalent to that after placebo. No treatment-related effects were detected in vital signs, blood pressure, or plasma concentrations of cortisol, insulin, glucagon, histamine, epinephrine, or norepinephrine. Most of the subjects were well educated and overweight and had a family or personal history of allergic reactions. The subjects who had headaches had lower plasma concentrations of norepinephrine (P less than 0.0002) and epinephrine (P less than 0.02) just before the development of headache. We conclude that in this population, aspartame is no more likely to produce headache than placebo.  PMID: 3657889, UI: 88014077

Aspartame Toxicity Information Center    Mark D. Gold
www.HolisticMed.com/aspartame  603-225-2100
"Scientific Abuse in Aspartame Research"
http://www.holisticmed.com/aspartame/abuse/methanol.html
mgold@tiac.net  12 East Side Drive #2-18 Concord, NH 03301

http://www.holisticmed.com/aspartame/abuse/migraine.html  :

"Scientific Abuse in Migraine/Headache Research Related to Aspartame":

"Other industry researchers have cited this study as evidence that aspartame does not induce headaches (Butchko 1994, Leon 1989, Moser 1994). In addition, Yost (1989) claimed that aspartame is not more likely to cause headache than placebo. Tollefson (1992) of the FDA cited this Schiffman study as evidence that aspartame does not cause headaches. (The Tollefson review was discussed in detail in the Seizure Research Abuse section).

"What these researchers fail to mention is that the Schiffman (1987) research is useless because of major design flaws. It is also particularly troubling that none of the above-mentioned authors cited the Koehler (1988) double-blind study!

"Before we discuss the major flaws of the Schiffman study, I will present some background information. The study was partially funded by Monsanto/NutraSweet and conducted at the Searle Center at Duke University. (G.D. Searle is owned by Monsanto.) Susan Schiffman performed her research at the "Searle Center" at Duke University. The Searle Center is under the guidance of William Anlyan, a former G.D. Searle director. Schiffman is a former General Foods and G.D. Searle consultant. The FDA helped design the study protocol. [Gordon 1987, page 500 of US Senate 1987; Shapiro 1987, page 403 of US Senate 1987].)

"Schiffman (1987) major flaws:

  1.The aspartame was given for only one day.

  2.The aspartame was given in encapsulated form which would lower the toxicity by eliminating the sudden absorption of the excitotoxic amino acid and methanol (Stegink 1987). The absorption of the excitotoxin is gradual, somewhat closer to what happens when ingesting food. The methanol is absorbed more slowly and that may significantly reduce toxicity as happens when food in the stomach slows methanol absorption (Posner 1975).

  3.There was no baseline frequency of headaches determined before administering aspartame or placebo.

"It is very important to note the main distinction between the Koehler (1988) study and the Schiffman (1987) study. While both studies used capsules, which would be expected to significantly reduce aspartame toxicity, and both studies used subjects who claimed to have headaches from aspartame, the Koehler (1988) study administered aspartame for four weeks, while the Schiffman (1987) study administered the aspartame for only one day!

"When one examines the double-blind studies funded by the aspartame industry, a pattern develops. Industry-supported research on subjects who have reported serious reactions to aspartame is almost always one day long and the aspartame is administered in capsules (e.g., Hertelendy 1993, Rowen 1995, Schiffman 1987). Industry-supported research that lasts several weeks is usually performed on individuals that might be expected to experience adverse reactions after at least several months of aspartame use (e.g., Shaywitz 1994) or on individuals even less susceptible to short-term aspartame toxicity, but where more sensitive neurological tests were conducted (e.g., Spiers 1998). The longer (but still relatively short) industry-supported research (3-6 months) usually uses healthy subjects who would likely only experience serious adverse reactions after many months or several years of aspartame use (e.g., Leon 1989, Trefz 1994). While the length of the study is not the only flaw in these industry-sponsored studies, there appears to be an obvious pattern of exceptionally short studies used on more susceptible subjects. It would appear that the manufacturer funds research with protocol designs virtually guaranteed to find no adverse reactions!" [end of Gold quote]

Am J Clin Nutr 1998 Sep; 68(3): 531-7
Aspartame: neuropsychologic and neurophysiologic evaluation of acute
and chronic effects.
Spiers PA, Sabounjian L, Reiner A, Myers DK, Schomer DL
Clinical Research Center, Massachusetts Institute of Technology,
Cambridge 02139, USA.
Paul A. Spiers  paspiers@mit.edu  617-253-6797
and 978-887-6220  Neurological Associates
Donald L. Schomer, M.D., Assc. Prof. Neurology, Beth Israel Deaconess
Medical Center, Harvard Medical Sch., dschomer@bidmc.harvard.edu,
617-667-3999

This study, done on or before 1993, was described in an abstract in 1993: then Richard J. Wurtman, Ph.D., Director of the CRC, was listed as an author, but not in 1998. It was paid for by NutraSweet Co. It used 48 healthy college students, half male and half female in each group of 24, high-dose and low-dose aspartame, also tested with placebo and sucrose, who took 20 days each of daily aspartame, sucrose, or placebo, and were tested clinically on the morning of the 20th day, before the last dose. The study is summarized by Schomer, Spiers, and Sabounjian on pages 225-31 in "The Clinical Evaluation of a Food Additive: Assessment of Aspartame," 1996, CRC Press, 308 pages, Ed. by Tschanz C, Butchko H, Stargel WW, Kotsonis FN, all employees of Monsanto/NutraSweet.

High-dose, 45, and low-dose, 15 mg/kg daily, groups had 24 subjects each. The results showed that the total number of headaches was about the same for low dose, sucrose, and placebo, at 11,14, and 11, but only 4 headaches for the 24 high-dose subjects in 20 days. The probability of this is not given. The numbers for fatigue were 3, 4, 2, and 1,  for nausea 1, 3, 4, and 1, for acne 1, 4, 3, and 2. For these 4 symptoms, the most common reported, the high-dose group is far less than sucrose or placebo. This indicates that some sort of confounding processes were indeed operating, and that the study is therefore meaningless, unless we are to start proclaiming aspartame as the newest aspirin.

Wouldn't a few students simply stop taking pills, if they thought it caused headache, and wouldn't they also start taking regular aspirin? Wouldn't a few students continue their favored diet drinks and foods? Wouldn't exposure to MSG, claimed by many researchers to have similar toxic biochemistry and symptoms, also confound the results? Only a few malfunctions like this suffice to eliminate statistical significance in a group of only 24.

"Complaints of adverse experiences were recorded in blinded fashion." It is not clear whether a symptom log was kept on a daily basis, or if symptoms were discussed only at day 10 and 20. The scientific community should have access to the actual raw data for daily symptoms for each subject.

"We were clearly able to distinguish the subjects in the high-dose aspartame group when they received the aspartame treatment because they had significantly elevated fasting plasma phenylalanine concentrations (Figures 3 and 4)..." This was about a 30% higher value at 85 minutes after the 3 PM dose on day 10, compared to placebo or sucrose. Is this kind of rise seen from consumption of phenylalanine in ordinary foods?

Since aspartame and its products, methanol, formaldehyde, and aspartic acid are cumulative toxins, we would expect symptoms to increase over  the 20 days, and to continue afterwards when the subjects were given sucrose and placebo. Since vulnerability varies greatly, we would expect a few subjects to be providing most of the symptoms. It might be illuminating to have the raw data on each of the subjects.

Moreover, when aspartame is given in capsules and at meals, then it is released gradually into the body, along with foods that mitigate its effects, while diet soda, the main source of aspartame, allows aspartame to be absorbed quickly, often with little food. In many cases, symptoms may not develop until after months and years of daily exposure, as in the case of tobacco. Finally, the sample of 24 in the high-dose group allows us to infer, at best, even if the study had impeccably consistent results, that the incidence of harm within 3 weeks in healthy college students is perhaps less than 5 or 10% at the 95% confidence level.
***********************************************************************

Rich Murray  Room For All  rmforall@earthlink.net
1943  Otowi Road   Santa Fe, NM 87505  505-986-9103

M.I.T. (physics and history, BA, 1964), Boston U. Graduate School (psychology, MA, 1967): As a concerned layman, I want to clarify the aspartame toxicity debate.

http://health.groups.yahoo.com/group/aspartameNM/message/618
long 40K summary

Excellent 5-page review by H.J. Roberts in "Townsend Letter",
Jan 2000,  "Aspartame (NutraSweet) Addiction"
http://www.dorway.com/tldaddic.html      http://www.sunsentpress.com/
H.J. Roberts, M.D.   HRRobertsmd@aol.com   sunsentpress@aol.com
Sunshine Sentinel Press 6708 Pamela Lane West Palm Beach, FL 33405
800-814-9800 561-588-7628 561-547-8008 fax
1038 page text   "Aspartame Disease: An Ignored Epidemic"
published May 30  2001    $ 85.00 postpaid    data from 1200 cases
http://www.aspartameispoison.com/contents.html    34 chapters

Here is research in 1998 at a very low level of aspartame ingestion, 10 mg/kg, for rats, which have a much greater tolerance for aspartame than humans. The same level for humans would be about 1 or 2 mg/kg. Many headache studies in humans used doses of about 30 mg/kg daily. A daily dose of 2100mg aspartame, about 4 L diet soda, used in many experimental tests on humans, supplies 210mg methanol into the body. Many cases report a typical serious symptom syndrome at this level.

This report shows that aspartame causes binding of methanol's product, formaldehyde, a potent, cumulative toxin, into tissues.

Life Sci June 26 1998; 63(5): 337-49 From PubMed
Formaldehyde derived from dietary aspartame binds to tissue
components in vivo.   ["Trok-ho"]
Trocho C, Pardo R, Rafecas I, Virgili J, Remesar X,
Fernandez-Lopez JA, Alemany M, Departament de Bioquimica i
Biologia Molecular, Facultat de Biologia, Universitat de Barcelona,
Spain.    http://www.presidiotex.com/barcelona/index.html

Sra. Carme Trocho, Sra. Rosario Pardo, Dra. Immaculada Rafecas,
Sr. Jordi Virgili, X. Remesar, Dr. Jose Antonio Fernandez-Lopez,
Dr. Maria Alemany Fac. Biologia
Tel.: (93)4021521, Fax: (93)4021559
alemany@porthos.bio.ub.es    bioq@sun.bq.ub.es
rafecas@porthos.bio.ub.es      remesar@porthos.bio.ub.es
Sra. Carme Trocho    Tel.: (93)4021544, Fax: (93)4021559
***********************************************************************

http://www.catalystmagazine.com
 Kenna Simmons, Editor Catalyst magazine 3379 Peachtree Rd.,
 Suite 300 Atlanta, GA 30326 Tel: 404-888-0555
ksimmons@catalystmagazine.com

http://www.nutrasweet.com/infocenter/consumer/otherssay/fibronewsletter.asp

The Facts About Aspartame "Disease"
 by Kenna Simmons

Maybe a well-meaning friend sent you the e-mail letter by "Nancy  Markle" linking aspartame to fibromyalgia — as well as to  lupus, multiple sclerosis (MS), Alzheimer's disease, diabetes, Gulf  War Syndrome and seizures. This e-mail, actually written by a  woman named Betty Martini who is an anti-aspartame advocate, has been circulating since 1995 but recently experienced a  renewed lease on life.

The claims made in the e-mail aren't supported by scientific evidence. The primary claim is that aspartame, an artificial sweetener marketed as NutraSweet and found in many diet drinks, causes "methanol toxicity" and leads to systemic lupus erythematosus (SLE) and MS. Aspartame does contain methanol  (when digested, it yields about 10 percent methanol by weight), along with the amino acids aspartic acid and phenylalanine. However, many fruits and vegetables also contain methanol; in fact, there is more methanol in a glass of tomato juice than in a diet drink. In the body, methanol is converted to formic acid and then to carbon dioxide and water, which are quickly eliminated. The body doesn't treat these substances any differently, whether they come from fruit or aspartame.

Another claim made in the e-mail letter is that aspartame is responsible for an increase in the number of brain tumors in the U.S. A 1996 report in the Journal of Neuropathology and Experimental Neurology (Vol. 55, No. 11) did note an increase in the incidence of malignant brain tumors and suggested that aspartame might be a "promising candidate" for the increase. (The report did not include a study of aspartame.) But data from the National Cancer Institute's public database on cancer incidence in the United States indicates that the number of brain tumors reported had been on the rise from 1973 to 1985, possibly due to improved methods of detection. Aspartame was approved by the FDA as a food additive in 1981, 8 years after the increase in brain tumors began. Since 1985, the numbers have remained steady, and actually decreased from 1991 to 1993.

A recent double-blinded study in the American Journal of Clinical Nutrition (Vol. 68, No. 3) reported that even large doses of aspartame had no effect on people's health. For one month, participants ingested no aspartame at all. Over the next three months, for one month each, they ingested placebo, sucrose (natural sugar), and 45 mg/kg of aspartame — the equivalent of about 17 12-ounce diet drinks per day for male subjects or 14 diet drinks for female subjects. All participants underwent physical and psychological testing. Participants showed no changes in physiology, brain activity, mood, memory or behavior. Equal numbers of headaches, fatigue and nausea were reported by the subjects when they took placebo and sucrose as when they took aspartame.

To put these dosages into context, the FDA establishes an Acceptable Daily Intake (ADI) for most food additives. For aspartame, the ADI is 50 mg/kg; that's about 20 12-oz. diet soft drinks or 97 packets of Equal for the average 150-pound adult. (A 12-oz. diet drink contains about 200 mg of aspartame.) However, the average person's consumption of aspartame is about two to three mg/kg, or about four percent of the ADI. The ADI includes a large margin of safety — it is often 100 times greater than the level found to cause no effects in animals — so even if you exceed the ADI, you probably still will not ingest a dangerous amount of aspartame.

There are some people for whom aspartame intake must be monitored: those with a rare genetic disease called phenylketonuria (PKU), who cannot properly metabolize phenylalanine, a component of aspartame. People with PKU must strictly limit the amount of phenylalanine they consume, whether it's from aspartame or foods such as meat, nuts and milk.

Studies that investigated whether aspartame can cause headaches in some people have conflicting answers: A 1987 study reported in the New England Journal of Medicine (Vol. 317, No. 19) found that aspartame was no more likely to cause headaches than placebo, whereas a 1994 study published in Neurology (Vol. 44, No. 10) concluded that it appeared some people were susceptible to headaches caused by aspartame. If you think you are susceptible to "aspartame headaches," try eliminating it from your diet and see if your headaches decrease.

Other Claims Made by the "Nancy Markle" Letter
There is no way to examine her statement that aspartame causes fibromyalgia because "Nancy Markle" does not try to support that claim in her letter. The e-mail has been so frequently discussed in fibromyalgia support groups and Internet news groups, however, that we have provided below examinations of the letter's more extensive claims about aspartame and other conditions to shed some light on the kind of logic that characterizes the letter in general.


     "The EPA announced that there was an epidemic of multiple
     sclerosis and systemic lupus." First of all, the Environmental
     Protection Agency doesn't track disease prevalence; the
     National Institutes of Health (NIH) and the Centers for
     Disease Control and Prevention (CDC) do. Second, there is
     no epidemic; the numbers of people diagnosed with MS or
     lupus have remained relatively constant.
     "Methanol toxicity mimics multiple sclerosis; people were
     being diagnosed with multiple sclerosis in error." According
     to David Squillacote, MD, senior medical advisor to the
     Multiple Sclerosis Foundation, "there is no evidence that
     aspartame in any way causes, provokes, mimics or
     worsens MS." In addition, Dr. Squillacote calls the claims
     regarding how methanol is metabolized "wildly inaccurate,"
     noting that volunteers have taken 600 mg of aspartame
     each hour for eight hours without any rise in their methanol
     levels.
     "When we get people off the aspartame, those with
     systemic lupus usually become asymptomatic." According to
     Evelyn Hess, MD, chair of the Lupus Foundation of America
     Medical Council, there is no proof that aspartame causes or
     worsens lupus.
     "Methanol in the aspartame converts to formaldehyde in the
     retina of the eye." High levels of methanol in the blood can
     cause vision impairment and blindness. But remember, the
     aspartame in a diet drink contains less methanol than a
     glass of fruit juice, and study participants have taken large
     amounts of aspartame without experiencing any visual
     problems.
     "Aspartame changes the brain's chemistry. It is the reason
     for severe seizures." A randomized, double-blinded,
     placebo-controlled study reported in the journal Epilepsia
     (Vol. 36, No. 3) found that dosages of 50 mg/kg of
     aspartame were no more likely to cause seizures than
     placebo in people who had reported their seizures were
     due to aspartame.
     "This drug also causes birth defects." According to a 1988
     article in the Journal of Reproductive Medicine, aspartame,
     when consumed within FDA guidelines, is safe for pregnant
     women and does not expose the fetus to danger.
     "Aspartame is especially deadly for diabetics." According to
     a statement by the American Diabetes Association, "There
     is no credible scientific evidence linking aspartame to any
     health-related problems for people with diabetes."
     "Aspartame Disease is partially the cause to what is behind
     some of the mystery of the Dessert (sic) Storm health
     problems." So far, researchers haven't been able to
     discover what causes Gulf War Syndrome, though some
     theories center on exposure to toxic gas during the Gulf
     War. A 1997 congressional investigation indicated that
     possible causes might include exposure to pesticides or
     smoke from oil well fires. No evidence exists to suggest that
     aspartame has anything to do with Gulf War Syndrome, and
     the aspartame intake of our troops was never monitored.


A Conspiracy Theory
The e-mail claims that a conspiracy between Monsanto (maker of NutraSweet and Equal), the American Diabetes Association, the American Dietetic Association, the FDA, and various researchers is responsible for a cover-up of the truth about aspartame. Conspiracy theorists dismiss studies because they are funded by grants from Monsanto. However, in clinical trials and other studies, it is common for the maker of a drug or food additive to provide a grant to independent researchers. The studies mentioned above were published in peer-reviewed journals, which means that editors with no connection to Monsanto reviewed the studies and found the methods used for research acceptable.

Searle, the pharmaceutical subsidiary of Monsanto, is one of the Arthritis Foundation's several corporate sponsors. These sponsors donate money to help further the mission of the Foundation through supporting research and educational programs, but the Foundation does not endorse any organization's commercial products or services. Like all educational material created by the Foundation, this newsletter is reviewed by medical professionals and experts whose editorial and medical opinions are independent of the views of any corporate sponsor. A list of medical advisory board members appears on page 2.

Fibromyalgia Wellness Letter, April 1999, Vol. 2, Issue 2. A
publication of the Arthritis Foundation
****************************************************

 


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