http://groups.yahoo.com/group/aspartameNM/message/911
RTP journal ties to industry critized by CSPI: Murray: 12.9.2 rmforall

Subject: [Quackbusters] Scientific Journal Compromised by Industry Ties
Date: Thu, 5 Dec 2002 21:22:36 -0500
From: "Ashley Hotz" <ahotz@...>
Reply-To: Quackbusters@yahoogroups.com
To: "Quackpots mostly.." <Quackbusters@yahoogroups.com>

http://www.cspinet.org/new/200211191.html

November 19, 2002 - Center for Science in the Public Interest -
For Immediate Release: Scientific Journal Compromised by Industry Ties
-- Tobacco, Chemical, & Drug Companies' Funding Goes Undisclosed, Say
Critics

The integrity of a seemingly independent scientific journal is being
questioned today by 45 prominent scientists and physicians. They
charge that the journal, Regulatory Toxicology and Pharmacology
(RTP), may let the anti-regulatory interests of its corporate patrons
trump sound science. The journal, which has a strong editorial bias
against government regulation, is accused of hiding its authors' and
editors' extensive financial ties to tobacco, chemical,
pharmaceutical, and other industries. The critics told the journal's
publishing house that those undisclosed financial ties pave the way
for research skewed in favor of industry.

"RTP reads more like a house organ of big business than an
independent, peer-reviewed scientific journal," said Virginia A.
Sharpe, Ph.D., director of the Integrity in Science Project at the
Center for Science in the Public Interest. "It is hard for anyone to
have confidence in RTP's published research when blatant conflicts of
interest are concealed."

RTP is the official journal of the International Society for
Regulatory Toxicology and Pharmacology (ISRTP), a membership
organization that receives major financial support from chemical,
drug, and tobacco companies. The journal is published by Academic
Press, a unit of Elsevier, one of the world's leading publishers of
scientific journals. According to the scientists' letter to Academic
Press, many RTP papers are written by scientists from industry labs
or by industry-paid lawyers and lobbyists. The same industries might
then use RTP articles in court to help derail lawsuits, or to make
the case for less regulation in legislative- and executive-branch
proceedings, according to critics.

For instance, Gio Gori, the current editor of RTP, received $30,000
from the tobacco industry to write a paper entitled "Mainstream and
environmental tobacco smoke." That paper, which downplayed the risks
of second-hand smoke, was published in RTP. The tobacco industry used
Gori's paper to argue against the Environmental Protection Agency's
efforts to protect nonsmokers from second-hand smoke.

"I am distressed to see a 'scientific' journal that serves as a pawn
for industry and that sometimes publishes papers whose conclusions
aren't supported by the data," said James Huff, Ph.D., a toxicologist
and senior investigator at the National Institute for Environmental
Health Sciences in Research Triangle Park, N.C. "I question whether
there is even a bona fide peer-review system in place at RTP."

The letter urges Academic Press/Elsevier to insist that the journal
sever its ties to the industry-sponsored ISRTP, reconstitute its
editorial board to reduce the influence of industry, and adopt a
strong conflict-of-interest policy. Such a policy, say the critics of
RTP, would prohibit certain ties and require disclosure of all of the
relevant affiliations of the editorial board members and authors,
including employment, honoraria, grants, consultancies, and expert
testimony.

"If Academic Press is to preserve its own credibility, it needs to
ensure that its publications abide by basic standards of journalistic
ethics," said Sharpe. "By looking the other way, the publisher not
only damages its own reputation but damages the reputation of
peer-reviewed science."

In addition to Huff, others signing the letter to Academic Press
include CSPI executive director Michael F. Jacobson, Lynn R. Goldman
of Johns Hopkins School of Public Health, Peter Infante of George
Washington University, Philip J. Landrigan of Mount Sinai School of
Medicine, Herbert Needleman of the University of Pittsburgh School of
Medicine, David Ozonoff of Boston University, Lorenzo Tomatis, the
Chairman of the Scientific Council of the International Society of
Doctors for the Environment, and Arthur C. Upton of Robert Wood
Johnson Medical School.

Center for Science in the Public Interest
1875 Connecticut Ave., N.W. Suite 300
Washington, D.C. 20009
Phone: (202) 332-9110
FAX: (202) 265-4954
E-mail: cspi@...
***********************************************************************

To subscribe to this group, send an email to:
Quackbusters-subscribe@yahoogroups.com
***********************************************************************

http://groups.yahoo.com/group/aspartameNM/message/797
RTM: Butchko & Stargel: aspartame is not toxic Dec 2001 2.10.2 rmforall

[Comments by Rich Murray: At the end of this lengthly post, I
give a review of a pro-aspartame text, edited by these two industry
employees in 1996. In this post, I give information about the journal
and related associations, to help anyone who wants to evaluate the
scientific objectivity of this report. Other sources for
understanding the manipulation of science by vested interests include:

http://www.truthinlabeling.org/ Truth in Labeling Campaign [MSG]
Adrienne Samuels, PhD P.O. Box 2532 Darien, Illinois 60561
858-481-9333 adandjack@... "The Toxicity/Safety of Processed
Free Glutamic Acid (MSG): A Study in Suppression of Information"
Accountability in Research (1999) Vol 6, pp. 259-310

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

Regul Toxicol Pharmacol 2001 Dec;34(3):221-33
Aspartame: scientific evaluation in the postmarketing period.
Butchko HH, Stargel WW.
Medical and Scientific Affairs, The NutraSweet Company,
Mt. Prospect, Illinois, 60056

Prior to marketing, the safety of the high-intensity sweetener
aspartame for its intended uses as a sweetener and flavor enhancer was
demonstrated by the results of over 100 scientific studies in animals
and humans. In the postmarketing period, the safety of aspartame
was further evaluated through extensive monitoring of intake,
postmarketing surveillance of
anecdotal reports of alleged health effects,
and additional research to evaluate these anecdotal reports and other
scientific issues. The results of the extensive intake evaluation in
the United States, which was done over an 8-year period,
and the results of studies done in other countries demonstrated intakes
which were well below the acceptable daily intakes set by the FDA and
regulatory bodies in other countries, as well as the Joint
FAO/WHO Expert Committee on Food Additives. Evaluation of the anecdotal
reports of adverse health effects, the first such system
for a food additive, revealed that the reported effects were generally
mild and also common in the general population and that there
was no consistent or unique pattern of symptoms that could be causally
linked to consumption of aspartame. Finally, the results of the
extensive scientific research done to evaluate these allegations
did not show a causal relationship between aspartame and adverse
effects. Thus, the weight of scientific evidence confirms that, even in
amounts many times what people typically consume, aspartame is
safe for its intended uses as a sweetener and flavor enhancer.
(c) 2001 Elsevier Science. PMID: 11754527
***********************************************************************

http://www.isrtp.org/index.htm
http://www.isrtp.org/nonmembers/members.htm

http://www.isrtp.org/sponsors.htm
American Chemistry Council
Bristol-Myers Squibb Company
Dow AgroSciences, LLC
Eastman Kodak Company
The Gillette Company
Indespec Chemical Corporation
Merck and Co., Inc.
The Procter & Gamble Company
RJ Reynolds Tobacco Company
The Sapphire Group, Inc.
Schering-Plough Research Institute
SmithKline Beecham Pharmaceuticals

http://www.academicpress.com/www/journal/rt.htm
http://www.academicpress.com/www/journal/rt/rteb.htm
http://www.isrtp.org/nonmembers/manuscript.html
The Regulatory Toxicology and Pharmacology
Journal (RTP) is the official Journal of ISRTP and
membership in the Society includes a Journal
subscription. These peer-reviewed papers are
devoted to significant developments, public
opinion, scientific data and ideas that bridge the gap
between scientific information and the legal aspects
of toxicological and pharmacological regulations.
Included are suggestions and concepts dealing with
regulatory decisions and the interpretation of
scientific knowledge as it influences regulatory
developments in the United States and other
countries. The Journal, now in its 17th year, has
wide international readership.

Manuscripts Scheduled to Appear
in upcoming issues of
Regulatory Toxicology and Pharmacology Journal

BELOW ARE MANUSCRIPTS SCHEDULED FOR PUBLICATION
IN RTP AS OF NOVEMBER 17, 2001

"Addendum" to Pelekis Paper Vol. 33:12-20, 2001

"Announcement" Gary M. Williams Award

"Lack of Binding to Isolated Estrogen or Androgen Receptors, and
Inactivity in the Immature Rat Uterotrophic Assay, of the Ultraviolet
Sunscreen Filters, Tinosorb M-active and Tinosorb S"
ASHBY, John et al.

"The Use of Non-Cancer Endpoints as a Basis for Establishing a
Reference Concentration for Formaldehyde"
BENDER, Joel

"Aspartame: Scientific Evaluation in the Postmarketing Period"
BUTCHKO, Harriett H. & W. Wayne Stargel

"Comparative In Vitro - In Vivo Percutaneous Penetration of the
Fungicide Ortho-Phenylphenol"
CNUBBEN, Nicole H.P. et al.

"Appraisal of Risks from Non-Occupational Exposure to Chlorpyrifos"
COCHRAN, R.C.

"Dose-Response for Formaldehyde-Induced Cytotoxicity in the Human
Respiratory Tract"
CONOLLY, R.B. et al.

"Chemomorphic Analysis of Malathion in Skin Layers of the Rat:
Implications for the Use of Dermatopharmacokinetic (DPK) Tape Stripping
in Exposure Assessment to Pesticides"
DARY, Curtis C., Jerry N. Blancato, and Mahmoud A. Saleh

"ICCVAM Evaluation of the Murine Local Lymph Node Assay (LLNA): II.
Conclusions and Recommendations of an
Independent Scientific Peer Review Panel"
DEAN, Jack H. et al.

"Testing Therapeutic Potency of Anticancer Drugs in Animal Studies:
A Commentary"
DEN OTTER, Willem et al.

"Elevating the Terms of the GM Food Debate" (Commentary)
FLAMM, W. Gary

"Extending the Threshold of Regulation Concept: de minimus Limits for
Carcinogens and Mutagens"
FIORI, Janice M. and Roger D. Meyerhoff

"A Procedure for Developing Risk-Based Reference Doses"
GAYLOR, David W. and Ralph L. Kodell

"Evaluation of Subchronic Toxicity Data Using Benchmark Dose Approach"
GEPHART, L. A. et al.

"The Costly Illusion of Regulating Unknowable Risks"
GORI, Gio Batta

"Frank Lu Award" (Announcement)
GORI, Gio B.

"The Effect of Different Tumor Groupings on Findings of
Anticarcinogenic Responses in Long-Term Rodent Bioassays"
GRAY, George M. et al.

"The TestSmart –HPV Program – Development of an Integrated Approach for
Testing High Production Volume Chemicals"
GREEN, Sidney et al.

"High-Alumina Low-Silica HT Stone Wool Fibers -- A Chemical
Compositional Range with High Biosolubility"
GULDBERG, Marianne et al.

"Genetic Polymorphisms in Assessing Inter-Individual Variability in
Delivered Dose"
HABER, Lynne et al.

"An Evaluation of the Possible Carcinogenicity of Bisphenol A to Humans"
HAIGHTON, Lois A. et al.

"Safety Assessment of DHA-rich Microalgae from Schizochytrium sp.
Part IV: Mutagenicity Studies"
HAMMOND, Bruce G. et al.

"A Study of the Biological Partitioning Behavior of n-Alkanes and
n-Alkanols in Causing Anesthetic Effects"
HAU, K.M. et al.

"Environmental Tobacco Smoke in the Non-Smoking Section
of a Restaurant: A Case Study"
JENKINS, Roger A. et al.

"ICCVAM Evaluation of the Murine Local Lymph Node Assay (LLNA)): III.
Data Analyses Completed by the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Peer Review
Panel"
KANEKE, Karen E. et al.

"SafetyEvaluation of Phosphodiesterase Produced from Penicilium
citrinum: Summary of Toxicological Data"
KONDO, Mitsuru et al.

"Analysis of Solvent Central Nervous System Toxicity and Ethanol
Interactions Using a Human Population Physiologically-Based Kinetic and
Dynamic Model"
MacDONALD, A.J. et al.

"Testing Extrapolation of a Biologically-Based Exposure-Response Model
from in vitro to in vivo Conditions"
MEBUST, M. et al.

"Categorization and Nomenclature of Vitreous Silicate Woods"
MOORE, Martin A. et al.

"Letter to the Editor" Commenting on Paper Published in Vol. 30, 1999:
96-109, "A Risk Assessment for Exposure to Glass Wool by WILSON, Langer
and Nolan"
MUSSELMAN, Rod P.

"Physiological Model-based Derivation of the Adult and Child
Pharmacokinetic Intraspecies Uncertainty Factors for Volatile Organic
Compounds"
PELEKIS, M. et al.

"Evaluation of the Carcinogenicity of 1,1-Dichloroethylene (Vinylidene
Chloride)"
ROBERTS, Stephen M. et al.

"Preclinical Safety Evaluation of Recombinant Human Interleukin-10"
ROSENBLUM, I.Y. et al.

"The Use of Mechanistic Data and the Handling of Scientific Uncertainty
in Carcinogen Risk Assessment"
RUDEN, Christina

"ICCVAM Evaluation of the Murine Local Lymph Node Assay (LLNA): I. The
ICCVAM Review Process"
SAILSTAD, Denise M. et al.

"An Analysis of the Mainstream Smoke Chemistry of Samples of the U.S.
Cigarette Market Acquired Between 1995 And 2000"
SWAUGER, J.E. et al.

"Chronic Toxicity and Carcinogenicity of Sucrose Fatty Acid Esters in
Fischer 344/DUcrj Rats"
TAKEDA, K. & M. Flood

"The In Vivo Rodent Test Systems for Assessment of Carcinogenic
Potential"
van der LAAN, Jan-Willem et al.

"Risk Analysis for Mortality from Respiratory Tumors in a Cohort of
Refractory Ceramic Fiber Workers"
WALKER, Alexander M. et al.

"Letter to the Editor" Response to Manuscript in Vol. 30, 2000: 219-225
WATTS, Peter and James Hopkins

"Joint Positive Control Testing in Guinea Pig Skin
Sensitization Tests - A Harmonized Approach"
WIEMANN, C. et al.

"Response" to ‘Letter to the Editor’" Paper Published in Vol. 30,
1999:109 "A Risk Assessment for Exposure to Glass Wool" by WILSON,
Langer, and Nolan
WILSON, Richard , A.M. Langer, and R.P. Nolan

"Investigations of Benzene Exposure, Benzene Poisoning and Malignancies
in China"
WONG, Otto
*********************************************************

Regulatory Toxicology and Pharmacology is primarily devoted to reports
of significant developments, public opinion, scientific data, and ideas
that bridge the gap between scientific information
and the legal aspects of toxicological and pharmacological regulations.
Papers dealing with
regulatory decisions and the interpretation of scientific knowledge as
influencing regulatory decisions will be included.
The Editors are particularly interested in articles about international
scientific developments and the legal and public health aspects of
toxicological and pharmacological regulations.

Manuscripts should be submitted to:
Dr. C. Jelleff Carr rtp-isrtp@...
Regulatory Toxicology and Pharmacology
6546 Belleview Drive
Columbia, MD 21046-1054
Tel. 410/992-9083
*********************************************************

http://www.isrtp.org/nonmembers/events.htm
EPA’s Characterization of Dioxin Risks:
Do Background Dioxin Exposures Pose a Human Health Threat?
Friday, October 6, 2000
Hilton Crystal City at National Airport
2399 Jefferson Davis Highway
Arlington, VA 22202
T. 703/418-6800 F. 703/418-3762 E-mail: rtp-isrtp@...
Co-Sponsored by
The International Society of Regulatory Toxicology and Pharmacology
American Bar Association Special Committee on Pesticides, Chemicals
Regulation and Right to Know
Chlorine Chemistry Council
FOCUS
For the past decade, EPA has been attempting to reassess the hazards
posed by 2,3,7,8­ tetrachlorodibenzo-p-dioxin and related compounds
(generally, "dioxins"). EPA published a draft dioxin reassessment in
1994. In response to recommendations and concerns expressed by its
Science Advisory Board and other commenters, EPA agreed to redraft
significant portions of its dioxin reassessment.
Recently, EPA released entirely new reassessment chapters
concerning dose-response modeling and toxicity
equivalence factors (TEFs), and significantly revised health and
exposure chapters. EPA also released a new Integrated Summary and Risk
Characterization chapter.
Despite EPA’s findings that dioxin exposures have decreased
precipitously over the last ten years and evidence that exposures will
continue to decrease ­ all due primarily to effective regulatory
programs ­ the Agency paints a dire picture concerning the threat
"background" dioxin exposures pose to human health.
For example, since its 1994 draft of thereassessment
EPA has determined that dioxin is a "known human
carcinogen," that it is a more potent carcinogen
and that it may cause significant cancer and
non-cancer effects in humans at background levels of exposure. EPA
concludes that current background exposures (much of it from food) to
dioxin and related compounds pose an upper-bound human cancer risk as
high as one in a hundred. If EPA is correct, as many as 64,000 annual
cancer deaths in the U.S. and 1,280,000 annual cancer deaths worldwide
could be attributed to background dioxin exposures.

Many in the scientific community, however, challenge EPA’s conclusions
asserting that the Agency failed to fully weigh the science, ignored
portions of the scientific evidence and
relied upon overly conservative assumptions to draw its conclusions.
For example, it has been pointed
out that more than 90% of EPA’s estimated human background exposures
to "dioxins" are exposures to non-TCDD compounds,
many of which have not been shown to
cause cancer in animals or humans. Further, it has been asserted that
human epidemiologic studies fail to demonstrate a cancer or non-cancer
hazard to humans at background levels of exposure. Indeed, many higher
human exposures (such as some occupational and accidental exposures)
have not been clearly shown to cause adverse human effects.

This conference will address a number of scientific, human risk and
health policy issues related to EPA’s recent draft dioxin risk
characterization, such as:
Does EPA accurately describe the science concerning dioxin’s
potential cancer and non-cancer risks?
Is the human population at risk?
Is the U.S. food supply safe?
What are the public health consequences of EPA’s draft risk
characterization?

"Neuroprotection and Neurorepair -- Cellular and Molecular Mechanisms"
International Conference in Combination with a Technical Workshop
March 1-4, 2000 Magdeburg, Germany
For further information, visit http://www.fan-magdeburg.de/neurorepair
or
contact Prof. Reiser, Tel. 011/49/391/6713088; Fax. 011/49/391-6713097,
Institut fuer Neurobiochemie,
Otto-von Guericke Universitaet Magdeburg Leipzigern Str. 44,
39120 Magdeburg, Germany,
organized by Klaus G. Reymann and Georg Reiser (Magdeburg, Germany).

The "FQPA Workshop" held March 1999, is available online. The
executive summary of the FQPA workshop, "The FQPA: A Challenge for
Science Policy and Pesticide Regulation," is now available on the Web
at http://www.cast-science.org/fqpa/fqpa.htm .
The March 1999 workshop
was co-sponsored by the Council for Agricultural Science and Technology
(CAST) and the International Society of Regulatory Toxicology and
Pharmacology (ISRTP). A limited number of printed summaries are
available for a $3.00 per copy shipping charge.

"Low Level Environmental Exposures -- State-of-the-Science Update"
December 1, 1999 Double Tree Hotel at National Airport Arlington, VA
Co-sponsored by The Environmental Sensitivities Research Institute
(ESRI) http://www.esri.org/links.html
and The International Society of Regulatory Toxicology and Pharmacology
(ISRTP)

A summary report will be published in the official journal of ISRTP
Regulatory Toxicology and Pharmacology. Additional information is
available at http://www.esri.org webmaster@...

"Toxicological Significance of DNA Adducts --
A Special Fall Meeting and Workshop"
October 21-22, 1999 John M. Clayton Hall Conference Center
University of Delaware Newark, DE
Presented by the Genetic Toxicology Association
The Fall meeting is organized as a 2-day meeting in which presentations
by DNA adduct experts are given on the first day. Panelists will then
convene to discuss current issues in
adduct measurement and interpretation.
Panelists will continue on Day 2 as a workshop to come up with
guidance recommendations for the design and interpretation of
DNA adduct studies intended for submission to regulatory agencies.
This effort is a continuation of a previous DNA adduct workshop in
1995 held under the auspices of the International Society of Regulatory
Toxicology and Pharmacology. The presentations and discussions will be
submitted for publication in RTP.
For information please call Dr. Raghu Nath, Covance;
tel: 703/893-5400 X 5270; fax: 703/759-5782; e-mail:
raghu.nath@...
You may visit the GTA home page at http://www.ems-us.org/gta
for registration information.

CHLOROFORM: EPA Policy or Science?
Thursday, June 17, 1999 Hilton Crystal City at National Airport
2399 Jefferson Davis Highway Arlington, VA 22202

The FQPA: A Challenge for Science Policy and Pesticide Regulation
March 23-24, 1999 Hyatt Fair Lakes Reston, VA
****************************************************************

http://www.ems-us.org/gta/ Genetic Toxicology Association 229
members
Topics of meetings have included:
P450 Metabolism/Induction
Transgenic Animals for the Evaluation of Exogenous Materials
Detection and Molecular Analysis of Human Genetic Disease
Tumor Promotion, Receptors, and Thresholds in Carcinogenesis
Assessing the Safety of the Products of Biotechnology
Measurement of Indirect Genotoxicity
In Vivo and In Vivo/In Vitro Measures of Germ Cell Damage
What do Federal Agencies Want in Genetic Toxicity Test Data?
Future Directions in the Application of Short Term Tests
Cytotoxicity Assessment and Dose Level Selection in Genetic
Toxicology Testing
Chemical Interactions in Mutagenesis
Variations in Cell Culture Conditions: Effects on the Outcome
of In Vitro Assays
****************************************************************

http://www.ems-us.org/index.html 853 members
about 50% academic, 25% government, 25% industry
The Environmental Mutagen Society (EMS) is the primary scientific
society fostering research on the basic mechanisms of mutagenesis as
well as on
the application of this knowledge in the field of genetic toxicology.
EMS has seven core scientific content areas. These are:
1.Exposure, detection and metabolism of DNA damaging agents
2.Responses to DNA damage (DNA repair and recombination,
changes in gene expression, cell cycle effects)
3.Mutational mechanisms (spontaneous and exposure related)
4.DNA technologies
5.Molecular epidemiology
6.Human health effects (developmental, cancer, aging, genetic
disease)
7.Applications: testing, regulatory issues and risk assessment

The EMS was founded in 1969 at Oak Ridge, Tennessee.

http://www.interscience.wiley.com/jpages/0893-6692/aims.html
Environmental and Molecular Mutagenesis publishes original research
articles on environmental mutagenesis.
It will publish manuscripts in the six general areas of
mechanisms of mutagenesis; genomics; DNA damage; replication,
recombination, and repair; public health; and DNA technology.
Subsumed under these six general areas are subject matters
that are appropriate for inclusion in EMM.

Mechanisms of Mutagenesis
spontaneous and induced mutation in indigenous and transgene systems
genomic instability
mutation rates
the consequence of mutation on fitness and evolution of organisms

Genomics
molecular epidemiology
genetic susceptibility
gene expression
biomarkers
small genomes and comparative genomics

DNA Damage
Indentification, detection, characterization, and quantification of
DNA damage
metabolism of chemicals into DNA-damaging agents

Replication, Recombination, and Repair
genetic and biochemical mechanisms
genetic and infectious disease
insertions, deletions, rearrangements, aneuploidy

Public Health
Issues impacting basic human health such as cancer, genetic disease,
aging, or acute and chronic disease
methodologies that will lead to better methods to determine risk and
help to define regulatory policy

DNA Technology
DNA microarrays, differential dispaly, and mutation detection analysis

novel sequencing strategies
bioimaging techniques
bioinformatics and functional genomics

The study of environmental mutagenesis is a multidisciplinary activity.
The journal is intended for investigators in such fields as genetics,
microbiology, biochemistry, basic cancer research, radiation biology,
and toxicology.
It should as well be of interest to a wide audience of scientists in
other areas of biology, chemistry, and medicine that are engaged
in public health research or in formulating public health policy.

Dr. Robert H. Heflich,
US FDA/National Center for Toxicological Research
3900 NCTR Rd., Jefferson, AR 72089, USA
phone (870) 543-7493; fax (870) 543-7393; E-mail: RHeflich@...
**************************************************************

Now, I want to add that the rather ad hoc classification that was
lobbied successfully for aspartame as a "food additive", not a
"drug", ensured that the industry never had to prove safety, nor
maintain records of doctor and user complaints: See this:

UPI reporter Gregory Gordon: 96K 3-part expose Oct 1987:
http://www.dorway.com/upipart1.txt

http://groups.yahoo.com/group/aspartameNM/message/63
Subject: Tschanz: "The Clinical Evaluation of a Food Additive:
Assessment of Aspartame" 11.11.99
Date: Thu, 11 Nov 1999 16:16:37 -0700
From: Rich Murray <rmforall@...>
Organization: Room For All

http://www.chipsbooks.com/clineval.htm
CLINICAL EVALUATION OF A FOOD ADDITIVE: Assessment of Aspartame
edited by: Christian Tschanz, Harriett Butchko, W.W. Stargel, Frank
Kotsonis 1996 308 pages $134.00 + shipping

Nov 11, 1999 Yes, I called Christian Tschanz in Chicago about last
March, and he had NutraSweet mail me a free copy, worth about $ 130.
It is a dreary, pious compilation of pro-aspartame studies-- it does
not have a common bibliography, just references to each of 22
chapters. I didn't find any reference to the seminal warning
by Woodrow Monte in 1984:
"Aspartame: Methanol and the Public Interest", and the
negative studies by Kohler SM et al (1988), Walton RG et al (1993), and
Van Den Eeden et al (1994) are not in the index-- because the index
in this expensive 308-page book does not include names!

Walton's study is reference #37 in Chapter 17: "Evaluation of Behavior,
Cognition, Mood, and Electroencephalograms in Normal Adults and
Potentially Vulnerable Populations," Donald L. Schomer, Paul Spiers,
LuAnn A. Sabounjian (the last is an employee at Richard Wurtman's
drug research company). It was cursorily summarized and criticized in
14 lines on page 222.
One claim is blatantly false: "This study was the first to suggest
a possible relationship of aspartame consumption to
side effects in an "at risk" group." Above, we see that Kohler (1988)
was earlier, with migraine victims, and Van Den Eeden (1994), not
mentioned, of course, was only a year later, two years before the
1996 date of copyright. For shame... Here is my review of Walton
(1993):

Walton, RG, "Adverse reactions to aspartame: double-blind challenge in
patients from a vulnerable population," 1993, with Robert Hudak and
Ruth J. Green-Waite, Biological Psychiatry, 34 (1), 13-17:
rwalton193@... 330-740-3671

Eight depressed patients, ages 24-60, and five non-depressed controls,
ages 24-56, employed at the hospital, were given for 7 days either
aspartame or a placebo, and then after a 3 day break,
given the opposite. Each got 2100 mg aspartame daily,
30 mg/kg bodyweight, equal to 10-12 cans of diet soda daily,
about a gallon. Despite the very small number of subjects, the
results were dramatic and statistically significant. The eight
depressed patients reported with aspartame, compared to placebo,
much higher levels of nervousness, trouble remembering, nausea,
depression, temper, and malaise. (For each symptom, p<0.01) The
five normals did not report strong enough differences between
aspartame and placebo to be significant. Initially, the study was
to be on a group of 40, but was halted by the Institutional Review
Board because of severe reactions among 3 of the depressed patients.

Again, statistical significance with only 8 depressed patients:
"In this study, patients most often began to report significant
symptoms after day 2 or 3." The incidence rate is very high,
indeed, about 1/3. The most common symptoms are entirely typical
of the voluminous records of case histories.

Koehler (1988) is reference 24 in Chapter 15 "Evaluation of Headaches,"
by Susan S. Schiffman, PhD of Duke University, sss@... ,
919-660-5657 , who takes almost a whole page to summarize, criticize,
and dismiss it. Here is my review:

Headache 1988 Feb;28(1):10-4
The effect of aspartame on migraine headache.
Koehler SM, Glaros A
Publication Types: Clinical trial PMID: 3277925, UI: 88138777

They conducted a double-blind study of patients, ages 18-55, who
had a medical diagnosis of classical migraines (normally having 1-3
migraines in 4-weeks), who were not on medications (other than
analgesics), and who suspected that aspartame had a negative
effect on their migraine headaches. The subjects were given 1200 mg
daily, aspartame or placebo, for four weeks, about 17 mg/kg. The
placebo group had no increase in headaches. Approximately half of the
subjects (5 of 11) who took aspartame had a large, statistically
significant (p = 0.02), increase in migraine headache frequency, but
not in intensity or duration, compared to baseline or placebo. Only 11
of 25 subjects completed the program: 8 dropped out, 4 began new
medications, 2 had incomplete records. They were at home.

Since 1/3 of the subjects dropped out, they may have been
choosing to avoid headaches-- were they unpaid? To achieve statistical
signifance with only 11 subjects hints that the incidence rate from
aspartame is very high, about 1/2, for migraine cases who believe
that they are hurt by aspartame.

Van Den Eeden (1994) was not mentioned anywhere, as far as I can
determine in the most likely chapters. Here is my review:

Stephen K. Van Den Eeden, T.D. Koepsell, W.T. Longstreth, Jr,
G. van Belle, J.R. Daling, B. McKnight, "Aspartame ingestion and
headaches: a randomized crossover trial," 1994, Neurology, 44,
1787-93 skv@... 510-450-2202:

In their introduction, they comment:

"In addition, the FDA had received over 5,000 complaints as of
July, 1991 in a passive surveillance system to monitor adverse side
effects. 17) Neurologic problems constitute the primary complaints in
these and several other case series, with headaches accounting for
18 to 45 %,depending on the case series reported. (17-19)"

Subjects, ages 18-57, were recruited who believed they got headaches
from aspartame, but were otherwise mentally and physically healthy.
They were paid $ 15 total, and were at home. Of the 44 subjects, 32
ontributed data to the 38-day trials: a week of inert placebo, a week
of either aspartame or placebo, followed by a week of the opposite,
and then this two-week cycle repeated. The daily dose was about
30 mg/kg. "The proportion of days subjects reported having a headache
was higher during aspartame treatment compared with placebo treatment
(aspartame = 0.33, placebo = 0.24; p = 0.04) (table 5)". Of the 12
subjects not included in the data, 7 reported adverse symptoms before
withdrawing.

Again, statistical significance with a moderate number of healthy
subjects, willing to be recruited by a newspaper ad, who believed
asprtame hurt them. The number of headaches for each subject for
each treatment week are given: it appears that 4 subjects had the
strongest increase in headaches from the run-in week or placebo week
to their first week on aspartame, jumping from 0 to 5, 1 to 6, 1 to 4,
0 to 5 headaches per week. So, about 4 of the 44 healthy people
recruited for the study, who believed aspartame hurt them, had a stong
increase in headaches from the first week of daily asparame exposure,
while 7 reported adverse symptoms before leaving, a total of 11 out of
44, an incidence ratio of 1/4. This is sky high, if we consider that,
if the incidence ratio for the about two hundred million users in the
USA is 1 of 100, that is 2 million cases. It is plausible that the
incidence ratio lies between 1 and 10 out of 100 for continuous daily
exposure.

So, it is obvious that if one is determined to dismiss a study, one
can always find some excuse to do so. The industry book ignored one
study, and dealt with the other two in widely separated chapters,
giving no clue that the other, confirming study existed. When all
three studies are carefully reviewed, then the key question, "Is
aspartame disasterously toxic in millions of users?" certainly can
not be firmly answered in the negative, for this "most widely
tested food additive in history", the usual industry PR slogan.
***********************************************************************

http://groups.yahoo.com/group/aspartameNM/message/912
aspartame: methanol, formaldehyde, formic acid toxicity:
brief review: Murray 12.10.2 rmforall

Rich Murray, MA Room For All rmforall@...
1943 Otowi Road Santa Fe, New Mexico 87505 USA 505-986-9103
***********************************************************************