Research Papers/Congressional Hearing

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Materials
Testimony Before Committee on
Government Reform Hearing:
Comprehensive Medical Care for
Bioterrorism
H.R. McDaniel, MD
Congressional Hearing
Comprehensive Medical Care for Bio-terrorism Exposure:
Are we making evidence based decisions?
What are the research needs?
Date:
1:00 P.M. EST Wednesday
November 14,2001
Committee for Government Reform
Honorable Daniel Burton, (R), Indiana Committee
Chairman
Hearing Room # 2154
Rayburn House Office Building 2157
Independence Avenue
Washington, D.C.
Presentation Title: Evidence Supporting the Potential for
Glyconutrients and Micronutrient Dietary Supplementation to
Support Natural Defense and Healing Mechanisms to Ameliorate
Bacterial, Viral and Fungal Infections
H.R. McDaniel, M.D.
Medical Director, Mannatech Inc.
Director of Research, Fisher Institute for Medical Research
Congressional Hearing; Comprehensive Medical Care for Bioterrorism Exposure-Evidence Based - Evidence Needs
November 14. 2001. Opening Statement by H. Reg McDaniel. M.D. Medical Director Mannatcch Inc.
Mr. Chairman and members of the House Committee for Government Reform and Oversight. It is a
privilege to be asked to appear before this panel of members of the House of Representatives and to be
invited to testify with professionals and scientists chosen to address the problem of bio-terrorism.
If it were not for the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA),
my comments and the written information that has been provided would not exist. I commend the
Congress for its unanimous vote that passed this legislation.
My comments and written submission are focused on the impact glyconutrients, dietary sugars, have
within the human body that support and enhance natural defense mechanisms against infectious agents.
Slide (1) identifies 30 scientists from 11 institutions in the United States that have performed
experiments on our dietary ingredients and reported their results for peer review. Slide (2) identifies
researchers outside this nation that have also contributed to the development of the clinical applications
of glyconutrition. Over 100 scientific presentations have been made by these scientists on the
glycoscience of these micronutrients.
When research was initiated in the early 80s it was scientific heresy to represent that sugars have
significant biological roles to play in the biochemistry of life processes. It had been incorrectly accepted
that glyconutrients, (dietary sugars. monosaccharides, carbohydrates) were simply burned for energy to
support life. Slide 3 is a collection of scientific journals that validate the very major role sugars play in
the structure and especially functions of the human body. Glycobiology and glyconutrients are now
recognized as cutting-edge technology.
Dietary sugars are critical components in the molecular
structure of compounds synthesized in cells that conduct the complex and marvelous process we call
life. This includes protection and defense against infectious agents.
Multiple bacteria and viruses have been shown to be killed or inactivated in cell cultures and in animals
by glyconutrients. Similar benefits are now being reported in humans adding the glyconutrients to their
diets. The journal Lancet in 1996 contains a review article citing similar saccharide induced action
against 37 infectious agents classified as pathogenic bacteria, viruses, fungi, and protozoans.
Evidence is expanding that supplying concentrated micronutrients, of which glyconutrients are a major
category, will support relief for acute and chronic diseases in a manner unmatched for a lack of toxicity
with unparalleled low-cost. This is accomplished by nutritional support of intracellular molecular
synthesis under control of the genetic code, that much like a computer program, contains the instructions
for the biochemistry of life, that is, normal structure and function. Such instructions enable appropriate
recognition and response to invading microorganisms.
How is this possible with non-toxic dietary supplements? There is a common belief promulgated by
authorities in medicine and nutrition that all one needs for good health and healing is a good general diet
with variety. The statement may be correct for those who are healthy. We have found it is not sufficient
for those with chronic and recurrent diseases, especially infections. In instances of unusual, epidemic, or
virulent infectious agent exposure, glyconutrient supplementation has been found effective for
enhancing general immune function and defense. When supplied at a higher level than available in
nature, sugars needed for cellular synthesis can take innate defense systems to a much higher level that
are effective against infectious agents. The biochemical principles responsible for this phenomenon and
mechanism of action are in your written material.
Body defense, such as the mechanisms that act naturally when we recover from a common cold or
influenza, can now be up-regulated to destroy virulent organisms associated with more serious disease.
Such benefit is the result of increased synthesis of cell-la-cell communication molecules that act like
tiny IBM cards sent between cells to provide instructions for destroying bacteria, viruses or other
infectious organisms, increasing the level of glyconutrients in the diet increases synthesis of these antiinfection molecules
In the bar graph provided is evidence of the functional antiviral activity described. It is an example of
the increase in general defense against infectious organisms that results when glyconutrients are
progressively added to the diet.
There is a current concern for not only preventing and destroying anthrax bacteria, but neutralizing
toxins that attack host cell membranes. Physicians have reported the apparent neutralization of bacterial
toxins produced by various species of bacteria and full recovery of patients near death. In addition, there
have been a few reports in major trauma or post-surgical infections complicated with multiple-drug
resistant bacteria, that dietary glyconutrients rendered the patient afebrile within hours of use and
shortened hospital expected stay. Minimal morbidity occurred in patients expected to die, based on
abundant prior medical experience.
Under provisions of DSHEA, glyconutrient formulations on which I am listed as a co-inventor have
been marketed for nearly eight years and over 750,000 people have consumed them. Currently, we
estimate over 200,000 persons consume our glyconutrients supplements daily. Several thousand have
taken the supplements continuously for eight years. There have been no significant toxic reactions or
fatalities, and complications have been limited to rare food allergies. This attests to the safety of these
concentrated dietary nutrients.
A research partnership of industry and academia, Texas A and M University School of Veterinary
Medicine and Mannatech Inc. stand ready to move this research forward. If supported by an action of
Congress, experimentation of bioterrorist infectious agents will be conducted. There is the real potential
through nutritional fortification to neutralize decades of dark-side research on the use of disease causing
agents designed to destroy or incapacitate millions of innocent people.
HRMcD 11/14/01
Slide I
ACADEMIC AND INDEPENDENT INVESTIGATORS WHO HAVE
CONTRIBUTED BASIC SCIENCE AND CLINICAL DEVELOPMENT TO GL
YCONUTRIENT AND MICRONUTRIENT FORMULATIONS AND INGREDIENTS
Texas A and M School of Veterinary Medicine, College Station, Texas
David Busbee, Ph.D.
Ian Tizard, Ph.D.
Maurice Kemp, Ph.D.
Robert Carpenter, D.V.M.
A.D. Chinnab, Ph.D.
S. Y. Peng, Ph.D.
R. Barhoumi, Ph.D.
L.P. Flood, D.V.M.
B.D. Campbell, B.S.
E. A. Merriam, Ph.D.
R.C. Burghardt, Ph.D.
C.J. R. Welsh, Ph.D.
University of Texas Health Science Center-Houston, Texas
Gallen Marshall, M.D., Ph.D.
M.D, Anderson Cancer Center- Radiobiology Institute, Houston, Texas
D.B. Roben, Ph.D.
E.L. Travis, Ph.D.
University of Texas Health Science Center- San Antonio, Texas
Charles Gauntt, Ph.D.
University of Texas Health Science Center- Lubbock, Texas
D. Lefkowitz, Ph.D.
S. Lefkowitz, Ph.D.
University of Texas Health Science Center, Dallas, Texas
J.B. Helderman, M.D.
D. Wonble, Ph.D.
University of Texas Health Science Center, Ft. Worth, Texas
J. Measel, Ph.D.
Baylor College of Dentistry, Dallas, Texas
J.P. Lenons, DDS, MS
W.B. Binnie, DDS, MSD
I. Gao, M.D., Ph.D.
T. Rees, DDS, MSD
J.M. Wright, DDS, MS
J.E. Hall, DDS
Research Foundation, San Antonio, Texas
G. Kaats, Ph.D
Southern Research Institute, Birmingham, Alabama
J. Kahlon, Ph.D.
New York Univenity Medical Center, New York City, New York
C. Reich, M.D.
CONTRIBUTORS TO THE DEVELOPMENT OF
GLYCONUTRIENTS RESIDING OUTSIDE THE UNITED
STATES
Basic Science:
Puerto Rico School of M.edicine, Dept. Plastic Surgery M.
Rodigues-Bigas, M.D.
Clinical Trials or Studies:
Cbloe Hospital, Tel Aviv, Israel
I. Tiomy, M.D.
T. Gnat, M.D.
Canadian HIV Trials Network, Vancouver, British Columbia, Canada
J. Ruedy, M.D.
Belgium Federation of Health Institutions
D. Weerts, Ph.D.
N. Clumeck, M.D.
Recent Issues of Journals Containing Articles Relating to
Glycobiology and Glycobiochemistry
Volume 161 of Acta Anatomica. 1998, contains 15 review articles with hundreds of independent
research article citations describing the vital role monosaccharides and their bio-polymers have in life
processes. The activities described range from cells differentiating into tissue types and organs in the
human embryo to the structure of cell membranes and hormonal regulation of what goes in and out of
cells in the mature adult. The first review article (N. Sharon) informs the reader that in the 1980s there
were virtually no papers published on glycoscience. The field of experimentation had expanded to the
point that a Medlar computer search for key word and titles for terms used in glycomzbiology and
glycoscience found over 20,000 papers published in 1995.
The volume 291, March 23IU issue of Science contains 12 short, but very technical articles on
glycoscience and its application to health. This is the official journal of the American Association for the
Advancement of Science. In addition, The Technology Review, the Massachusetts Institute of
Technology, magazine of innovation, October 200 I, issue contains a short overview of information
included in the above lengthy articles and their voluminous body of knowledge.
Slide 4
This graph is a demonstration of how there is an increase in destruction of virus infected target cells that
is directly related to the level of glyconutrient added to culture medium of harvested leukocytes that
were pre-cultured with the glyconutrient before being added to the bioassay culture. As was shown in
the handout, G. Marshall published evidence that cytokine production was enhanced by glyconutrients
in the pre-culture phase of white cell culturing. This functional assay is provided as an example of how
glyconutrition up-regulates innate defense mechanisms against infectious agents. Each rise in height of
the bar graph is the average for a group of experiments. The bar rises as the supply of glyconutrient was
increased in the medium of the pre-cultured white cells.
In the above experiments virus infected cells (Herpes II) are prepared in culture and then loaded with
chromium-51 isotope. Virus and isotope not taken inside the target cells are washed from the culture.
Leukocytes pre-cultured overnight with increasing amounts of glyconutrient, as indicated, are added to
the target culture cells. A type of white cell, natural killer (NK) lymphocytes. are activated by antiviral
cytokines. The NK cells attack and destroy the virus-infected cells by secreting an enzyme (perforin) to
cut lethal holes in the cell membrane of the virus infected cells to destroy the sources of virus
production. The bar plots are the leakage of the radio-isotope Cr-51 from the destroyed virus-infected
target cells after four hours of exposure to the NK lymphocytes. Note that the isotope leakage into the
medium is directly related to the level of glyconutrient supplied to the white cells before exposure to
the virus-infected cells.
Similar enhancement of other innate defenses against infectious agents has been demonstrated that
include an increase in phagocytosis and killing of yeast, Gram + and Gram - bacteria (S. and D.
Lefkowitz 2000.2001, and antibody production (Zacek, et.al. 1988, Gaunt 1997).
Congressional Hearing November 14, 2001
QUESTIONS
H. R. McDaniel, M.D. Medical Director, Mannatech, Inc. United States
Stephen Boyd, M.D., Ph.D. International Medical Director, Mannatech, Inc
1. Question
The presentation conveys a degree of confidence that micronutrients, especially glyconutrients will
perform successfully as a protection against bio-terrorist infectious agents. Yet, you indicate in your
executive summary that you have insufficient or incomplete science to support immediate use in the
civilian population and you do not say for certain that this approach will work. Is there other
information on glyconutrients that you have not provided this panel?
Answer, YES
1.
Our first generation glyconutrient is an USDA approved immune support agent with
veterinary approval as an immune adjuvant in day-old chicks that are vaccinated and is used by many
veterans in their anima1 practices against viral infections.
a.
Day old chicks receiving this USDA approved agent produced by Carrington
Laboratories, Irving, Texas, showed in a major study of 120 million chicks audited
at random, that a trivalent vaccine's flock protection rose from about 65% to over
95% of the vaccinated animals. The monitored chicks received their standard
vaccination and also received aloe polymannose that increased protection
approximately 30%.
b.
Veterinarians inform me that now they would not practice without the off-label use
of this same glyconutrient supplied in a sterile injectable drug classification.
Animals with parvovirus, distemper and other formerly untreatable viruses that
veterans in the past euphanized mother animals and their entire litters, now recover
and have no problems from the formerly lethal viral infection.
c.
It is known that feline leukemia is caused by a virus. Veterinarians have reported a
major increase in survival (over 75%) with salivary and serum clearance of the
virua1 antigen in 3 to 6 months of using this glyconutrient in this injectable
formulation. If there is difficulty with the drug classification of this necessary
mannose dietary sugar~ recall that table salt, (NaC1), in water, sterile, and in a vial
or bottle for injectable purpose is a drug, as is glucose.
d.
An independent charity Manna Relief Ministries uses the micronutrients in its
mission to over 80 orphanages in North America and beyond. In Romania an
orphanage averaging over 100 children at one time reports that 50% of their
children were in or on infirmary status with bacterial and viral infections. Each
year they averaged 30 deaths. Upon adding one per day of the child's candy bear
mixture of glyconutrients and phytonutrients, that is almost homeopathic in its
amount of micronutrients, the infirmary census is now virtually non-existent, that
is less than 10% per year have a viral or bacterial infection due to the preventive
activity supported and there has not been a death of a child since instituting this
nutritional support.
2. A Russian physician informed us in 1999, that behind the Iron Curtin they spent 40 years
developing a human micronutritional formulation for increasing human performance and improving
health. Their formulation contains all the ingredients of our formula, but they come from other
plants and they built their formula around plant sterols, while we built ours around dietary sugars.
The results in 13,096 Volga tank assemblers Graph 1, and 1,000 truck drivers in Graph II is most
informative. (see attached exhibits) This basic study was repeated in miners and smelter workers to
increase the environmental stress. While this study was not translated, it was stated that these
workers had similar benefits as the truck drivers. All these workers received AM and PM tea with
the formulation in the drink for 6 years. The slides attached show the benefits received. I draw
attention to the collapse in incidence of influenza, an infectious disease readily transferred in a
mass population. This may be indicative of the benefits that might be achieved in smallpox or
tularemia. We have had small group, and anecdotal reports of similar benefits in regard to
individuals who add micronutrients, especially glyconutrients to their diets. We have not had the
research funds to do major group studies to confirm the US formulation's ability to produce the
benefits experienced by the Russians.
Re-direct on question 1.
Dr. McDaniel, you provide a lot of information in the last question's response. Just what are you trying
to get across with the Russian Studies?
Response.
Under the Ford Administration a WIN campaign was organized to prevent what was feared to be a
potential 1919 pandemic of swine flu that could kill millions of people. Mass vaccination program
against the expected influenza agent was instituted. The irony is that the wave of flu that swept the
country was not of this antigenic strain, so the population was not protected by the strain that spread.
However, vaccinations are not given to large numbers of people without at down side of untoward
responses. Unfortunately, many persons who got the swine vaccine had nervous system syndromes, the
most common being Gullain-Barr'e Syndrome that paralyzes a person in an acute and an often
devastating chronic manner. Many suits were filed and many companies that make the vaccines went
out of business and large companies ceased to make vaccines due to the liability and incalculable
exposure or damages. That is the reason one company is trying to produce the anthrax vaccine.
Competitors were destroyed by the WIN event.
The Russian experience in truck drivers and not reported, but also in miners and smelter workers, was
that not only did the workers not get the influenza virus, but their general health problems like high
blood pressure and coronary heart disease problems were reduced. We have had similar anecdotal
reports from small numbers of patients and the general health surveys conducted in our company's
longitudinal study that has participants back to 1994 support such beneficial, side-effects. In a
published study of autistic children observed by their counselor and parents, not only did the children's
primary problem improve, but otitis media, sinusitis, bronchitis, allergies, asthma, infectious diarrhea
and other less frequent health problems were eliminated or reduced.
The effort to give millions of people the most economical of public health measures, a vaccine, is of
little value if the epidemic does not hit or the wrong vaccine is distributed for the threat that transpires.
There are neurological complications, as seen in the swine flu vaccine. The best case is that nothing
happens. By use of micronutrients the general health of the population is enhanced. If the Russian
results are applicable, and I believe they are, the general health of the nation would be improved, and
health care costs would be reduced for maladies prevented.
I hasten to add that such additional benefits with the American dietary supplement formulation
cannot be projected until the formal studies are conducted.
Question 2.
You make references for using nutrition to improve human health status, especially for
protection against various infectious microorganisms. You provide experiments in your
written data to support this position. Can you explain in a manner for the non-scientist how nutrition,
special food termed as a glyconutrient contained as a micronutrient in a dietary supplement, can do
what antibiotics and drugs have failed to do?
Response
I will be pleased to try. I speak to lay audiences over the North American continent attempting to
do this.
A. Each cell in a human being requires nutrients to be supplied that must come directly or
indirectly from the diet. Digested nutrient molecules are absorbed primarily from the small
intestine brought to the cells through the blood. The nutrient molecules are transported by
various mechanisms from the blood across the cell membrane into the cell. Inside the cell are
assembly sites called organelles where the molecules are connected together to make the
compounds that carry out the processes we call life. Some production is for structure (bone,
muscle, organs, connective tissue) and other produced compounds operate life processes that
are functions. Defense and repair from infectious agents constitute an important functional
activity conducted by producing special complex molecules comprised of combinations of
amino acids, sugars, fats and elements. The general term for life sustaining compounds are
glycoproteins and glycolipids (glyco is Greek for sweet or sugar) meaning sugars connected to
aminoacid chains or proteins and sugars connected to fat or lipid chains.
Graph III is what electron micrographic magnification with a special stain can demonstrate in
young metabolizing cells. The organelles that constitute an assembly line, ribosome,
endoplasmic reticulum and golgi are drawn in cartoon. These are the sites where the nutrients
are connected together to make the molecules of life. The genes in the nucleus are the blue
prints that provide instructions for what and how nutrient molecules are connected together to
make all the structure and function molecules illustrated at the bottom of the drawing.
This concept is not something new. Hippocrates from ancient Greece wrote, “Let your food be
your medicine and your medicine by your food.” Paracelsus, Father of Pharmacology in the
Middle Ages left this message, “All that man needs for health and healing has been provided by
God in nature, the challenge of science is to find it.” Roger Williams, Ph.D., in the modern era
wrote, “The human body heals itself and nutrition provides the resources to accomplish the
task.” Nutrition Against Disease 1971.
Graph III
If all the words used are confusing or challenging one only needs to appreciate that nutrients are
like parts supplied to an auto assembly plant and each cells functions like an auto assembly plant
that requires thousands of parts to be able to correctly produce cars. If one is short clutches or
breaks, the assembly plant does not function properly due to a "parts deficiency". Missing
nutrients result in fatigue, inability to recover from exhaustion, susceptibility to infectious
disease organisms and the list grows longer as the deficiency continues or the number of missing
nutrients increase. No breaks can be likened to a child with ADD / ADHD. No clutches for cars
to transfer power of the engine to the tires can be compared to a mother with chronic fatigue
syndrome. We have found dietary supplements provides the missing nutrients (parts) to restore
control in the child and energy for the mother. The corrections are made at the sub-microscopic.
biochemical level.
H R McDaniel, How Dietary Supplements Work, Proc.Fish.lnst. Med. Res., Vo1.2, No.3, p13-16, April 2003
Evidence
Supporting
the
Potential
for
Glyeonutrients
and
Micronutrient
Dietary
Supplementation to Support Natural Defense and Healing Mechanisms to Ameliorate Bacterial,
Viral and Fungal Infections
H. Reginald McDaniel, M.D.
Medical Director, Mannatech Inc.
Director of Research, Fisher Institute for Medical Research (Emeritus)
Executive Summary
In 1984-85 a group of symptomatic HIV -1 positive patients reported that oral aloe juice alleviated their
AIDS symptoms. It was found that the active anti-viral ingredient in aloe leaf gel was polymannose.
This is a micronutrient that supports synthesis of innate defense molecules that destroy multiple types of
infectious agents including bacteria and viruses. The mechanism of action is not that of antibiotics that
poison or block the metabolism of microorganisms. The biochemistry and immunology supported by
this glyconutrient type of micronutrient-based defense is based on up-regulation of innate, natural
mechanisms for protection against and destruction of microorganisms. Thus, antibiotic resistant
organisms are destroyed by this enhancement of natural defense mechanisms through optimal dietary
supplementation. The exact site and step in glycoprotein synthesis within the cell where mannose of
aloe origin is utilized has been defined. This led to recognizing and formulating a mixture of natural
saccharides (dietary sugars) known to be necessary in the golgi to provide a more efficient cellular
synthesis of defense and tissue repair molecules. The current generation of glyconutrients (Ambrotose
@, Mannatech, Inc.) is 5 to 20 times more bioactive than the original aloe polymannose when it is
added to the diet alone. Glyconutrients support enhancement of the genera1 immune mechanisms and
are virtually non-toxic, low cost and are effective against common infectious agents, multiple drugresistant nosocomial organisms, toxin producing bacteria, and are predicted to be effective against wargrade modified organisms, bacterial and viral. Research is required, but can be rapidly conducted to
confirm preliminary basic science experiments, anecdotal reports, and other soft supportive data and
observations. At this point the science is not adequate for establishing a national policy or professional
recommendations for the mass use of glyconutrients. The information available is strongly supportive of
initiating further research that has a high probability for being successful. Texas A and M University
School of Veterinary Medicine with its Texas Veterinary Medical Diagnostic Laboratory has joined
with Mannatech Inc. in an academic/industry partnership to evaluate this proposal. This university
laboratory has been approved by the CDC to culture anthrax and has ideal containment facilities and
expertise to rapidly prove and develop this preventive and therapeutic approach designed to thwart bioterrorist infectious agents designed to destabilize the society of America and its allies.
Recent Historical Background
1984-85
Eight AIDS syndrome patients claimed reversal of symptoms and a return to school or work
following the intake of specially stabilized aloe gel beverage marketed in the health food industry
by Avacare of Dallas, Texas. 1
Aloe polymannose (APM) a white powder was stabilized, extracted, concentrated, and freeze-dry
preserved from the aloe leaf gel. This biologically active principle was eventually determined to be
comprised of polydispersed molecular weight chains of mannose sugars, i.e. a complex carbohydrate. 2
APM was demonstrated in multiple scientific presentations to induce in many patients increases in CD4
lymphocyte levels and reduced HIV-1 viral loads over two-logs and some became P-24 core antigen
negative. Skin anergy and lost weight was restored in 6 to 8 months. Infections and lymphadenopathy
resolved. Kaposis sarcoma lesions faded and become undetectable. Those with hepatitis had normalized
liver enzymes and there was a general increase in energy and productivity of those with either HIV-1 or
HVB, or both chronic viral infections. 3
APM synergism was noted with antiviral agents, ketoconazole, IBD therapy agents, antibiotics,
psychotropic drugs, and cytotoxic chemotherapy. 4 In FDA Phase I toxicity testing of APM, no
significant toxicity was noted in acute or chronic animal testing culminating with intravenous
infusions in human volunteers that demonstrated no evidence of kidney, liver, bone marrow, or stem
cell damage.5,6
Lymphocyte (CD4) in vitro protection from HIV -1 infection was demonstrated with APM in
leukocyte cultures. APM oral loading of a donor followed by collection and inoculation of leukocytes
with HIV-1 blocked infection of CD4 target cells. Titration of female pooled-donor lymphs in culture
with APM challenged with HIV -1 demonstrated protection ofviral infection of target cells.
Complementary DNA dot-blot evidence of inhibition of vRNA transcription was demonstrated 1
In experiments reported in the 1980s, infection and cytopathology was blocked or accelerated
organimn killing was reported using APM for:
Herpes II 8
Measles 8
Newcastle virus 9
Staphylococcus 11
Coxsackie B 12
Rhinotracheitis 8
HIV-l 8
Candida species 10
Escherichia Coli 11
Attempts were made to find a viral agent that was not inactivated by glyconutrients. Coxsackie B with a
predilection for murine cardiac muscle and beta cells of the pancreas was evaluated in murine models. 12
Coxsackie virus is noted for its low antigenicity and inability for the immune system to detect the agent.
Animals provided aloe polymannose had fewer cardiac lesions, beta cell destruction was prevented if
APM was given before inoculation. Delayed administration of APM resulted in regeneration of
pancreatic beta cells, lowering of elevated blood sugar levels and antibody titers against the virus that
were higher than controls.
In a review published in 1996, oligosaccharides (complex sugars) were reported by scientists
independent of this research team to be anti-infective against 28 bacterial
species, 4 viruses, 1 yeast, and 4 protozoans. 13
Feline retroviral "AIDS" infected cats responded clinically to APM 14
Leukemia in cats is known to be caused by a virus and the viral antigen can be detected in saliva and
serum. Administration of aloe polymannose alleviated clinical and hematological evidence of the feline
leukemia; animals became antigen negative and survival was enhanced. 15.
A CHANCE AIDS PATIENT OBSERVATION:
In 1990 an AIDS patient on APM noted he had not had influenza or an URI for five years despite
multiple annual infections prior to APM addition to the diet. An inquiry led to discovering virtually all
the study patients had not had or there was a significant reduction in upper respiratory infections for
extended periods.
To further test the above anecdotal reports, employees in Dallas Fort Worth-Medical Center and
Carrington Labs were provided oral APM during viral epidemics in the community. Mates often
succumbed to the local viral epidemic while employees taking APM were protected.
It was found that loading with APM upon onset of the first symptoms of a URI /viral syndrome often
produced an overnight curtailment of symptoms. Some claimed a milder and shorter course if taking
APM was delayed until Symptoms were more advanced. Placing APM in the cheek at bedtime was
found to enhance benefits, especially when there was laryngitis. Nasal allergies, sinusitis gingivis
periodontal disease, diseased loose teeth, hearing deficit, sinus headaches, hay fever, and migraines
were reported to respond as a secondary benefit. Benefits in diabetics were most marked due to their
low threshold for succumbing to the above conditions.
Efforts to determine how such clinical benefits can be achieved were pursued. Mixed leukocytes were
cultured and progressive concentrations of glyconutrient was added to the medium. ELISA assays of
medium from the in vitro system demonstrated a dose/response increase in synthesis of cytokines ( See
Graph I) 16 associated with the inflammatory cascade. This is evidence of activation of the innate
general defense mechanisms of natural protection against micro-organisms that include bacteria and
viruses. Importantly, this mechanism of micro-organism destruction is not related to the mechanisms by
which antibiotics destroy infectious agents. So called, weapon-grade bioterrorist organisms with
induced multiple-drug resistance, would be expected to be destroyed with no difficulty. The “Achilles
Heel” could be the insertion of promoter growth segments from a rapidly growing bacteria into the
modified agent's genome.
Further evidence of completion of the natural defense mechanisms of action required to destroy
micro-organisms is shown in Graph II. 17 Target cells loaded with intracellular
chromium-51 and a herpes virus are covered with mixed-leukocytes incubated over night with
increasing amounts of glyconutrients. The most prominent activated cell is the natural killer lymphocyte
(NK cell) and its activity is well demonstrated by al10wing the pre-cultured cells to incubate with the
virus-loaded cells. If the glyconutrient is increasing cytokine production in leukocytes, then the NK cells
will attack and destroy the virus laden cells allowing the Cr-51 to leak into the medium. Graph II shows
that an increase in glyconutrient provided to incubating leukocytes increases the destruction of virus
laden cells by NK lymphocytes as evidenced by Cr-51 release into the culture medium. This is the
normal manner in which human beings recover from aerosol distributed viruses during annual
epidemics. This defense mechanism is enhanced by a supply of monosaccharides required for
glycoprotein and glycolipid synthesis, i.e. cytokines of defense.
It is a common to inform the public that "all a citizen requires for good health and healing is a good
general diet with variety." It is instructive to re-educate those who need to recover from a chronic
disease that is resistant to standard therapy or to prevent infections from pathogenic micro-organisms.
The above standard and accepted mantra is In serious error for those with a compromise In health or
weak defense and repair capacities. To enhance the immune system defenses or strengthen general
defense mechanisms to optimally respond to numerous epidemic bacterial and viral infections, a
fundamental principle of biochemistry. substrate availability dynamics, should be applied to the diet.
The Michaelis-Menten phenomenon (MMP) (Graph III) 18 describes the fact that if there is an increase
in supply of nutrients (A + B-) required to synthesis molecules of body defense (->C), symbolizing
cytokines, interferons, interleukins, antibodies, etc., more of the protective molecules are made. Graph I
and II are applications of this basic biochemical principle that shows the power of nutrition in
preventing disease and restoring health.
The biochemistry that is herein presented, supports the stated intent of the Dietary Supplement Health
and Education Act of 1994 (DSHEA). Passage of this act by congress set the stage for this presentation.
The increased supply of vital nutrients required for cellular synthesis to conduct body defense
mechanisms is increased by use of dietary supplements. OSHEA has facilitated the development of
research-based nutritional supplements.
The key to better understanding of Graph m is that at the lower left-end 0 one sees the availability of
nutrients in nature due to the high water and fiber content. An individual simply cannot consume the
volume 12 maximize the synthesis of defense and repair mechanisms coded in 2m: genes. The extraction
of nutrients from insoluble fiber and freeze-drying the vital molecules in supplements 0 increases their
availability for cellular synthesis. Levels of defense and repair molecules are, in fact. increased as shown
in Graph 1. The resulting enhanced defense against viruses is demonstrated in Graph III, a functional
assay for virus infected cell destruction.
This mechanism of action is a total departure from how antiviral and antibacterial pharmaceuticals act
to destroy infectious agents. Drugs attempt to disrupt or block the biochemistry of the micro-organism
and often exhibit significant side-effects and not infrequent toxicity. This nutritional approach with
concentrated dietary supplements increases the activity of the human body's natural mechanisms that
have fostered recovery from bacteria and virus infections since the beginning of human life.
Importantly, this approach developed under the freedom given by the DSHEA legislation is
economical, effective, and is free of chemical toxicity associated with drugs.
There are additional benefits associated with enhanced nutrition associated with dietary
supplementation that go beyond structure and functional support of health. In vitro experiments 19 have
supported clinical observations of patients, improved quality of life, energy, endurance, recovery from
fatigue and reduction in toxicity from cancer chemotherapy, radiation and chronic disease. In GRAPH
IV, liver cells analyzed by a con-focal scanning spectrometric microscopic laser demonstrate an
increase in intracellular reduced-glutathione levels of 50% in 300 seconds or 5 minutes upon exposure
to 50 ug/ml glyconutrient. This is a marked reduction in potential for free-radical damage and oxidative
stress associated with fever, infections and the toxins of micro-organisms. Anecdotal reports of
unparalleled recovery from toxic shock syndrome caused by bacterial toxins and re-perfusion collapse
with end-organ cellular destruction have been received. Such preliminary clinical observations require
further evaluation and experimentation under professional observation. Toxins associated with anthrax
and other potential bio-terror agents are either bound, inactivated or their damage is reduced or reversed
by mechanisms supported by increases in intracelluar reduced glutathione.
In Graph I it should be noted that GMGF or the synthesis of colony growth factor for granulocyte
macrophages is increased along a steady concentration gradient. This correlates well with the healing
and restoration enhancement that has been reported not only in normal animals and humans, but in
human diabetics. 20
The general potential for recovery from viral and bacterial toxin induced injury is enhanced by the
capacity of cells to release colony growth factors and related molecules that foster regenerative
activity.
In 1993 at the Berlin International AIDS Conference, sustained reductions in HIV-l viral load by PCR,
restorations of CD4 levels, return of weight and clinical amelioration for eight years was reported. 21
NOTE:
APM alone did not induce sustained or objective improvement of HIV -1 patients with P-24 core
antigen levels (Abbott Labs) of over 300 pg/dL or CD4s ofless than 200 mm3. In regard to clinical
utility, many AIDS patients have more advanced disease and evidence of immune system damage and
this put significant limits on the value of the first generation of glyconutrient technology. (Note recent
AIDS case responses to the current generation of glyconutrients and more complete micronutrients
reported later.)
In 1985 S. and R. Kornfeld published a detailed review showing that mannose, the sugar synthesized in
aloe vera leaves, is a vital glyconutrient used in the endoplasmic reticulum for initiation of intracellular
synthesis of glycoproteins and glycolipids, the structural and functional molecules of life. 22 These
molecules are essential for general defense and healing mechanisms of action including cytokines,
chemokines, acute reactive proteins, and antibodies. One would be remiss in failing to acknowledge
the immense value of this review of the intracellular bio-assembly of glycoproteins and glycolipids and
the critical role monosaccharides play in call synthesis.
IN 1994 THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACI' (DSBEA)
WAS PASSED
As found in the preamble of the legislation:
"Science has shown that nutrition is essential for good health,
to prevent disease, and restore health."
At this point I wish to state that the foundation for the phrase, "science has shown," was primarily
achieved by Roger William, Ph.D., and his scientific disciples. In his book, Nutrition Against Disease,
published in 1971. Dr. Williams states in his chapter, The Flaw in Medical Education, that the central
theme of his many books on nutrition and his life's work is,
"The human body heals itself and nutrition provides the
resources to accomplish the task."
Evidence of the wisdom of these words are in the DSHEA legislation, the mass benefits that have been
received by massive citizen use of dietary supplements, and this presentation. After passage of the
DSHEA legislation, research efforts with APM were focused on nutritional rather than a
pharmaceutical approach in health supportive efforts. This is highly significant in that if the
pharmaceutical pathway had been followed and resulted in success, the active ingredients available
daily for approximately $0.75 would have required a price often to twenty times that amount. One of
the stated intentions of the DSHEA was to reduce health care costs for the nation.
Sporadic reports of more rapid improvements in more advanced AIDS patients was anecdotally
received when APM with soy lecithin (AL 7/211), Dioscorea plant sterols, and freeze-dried
phytochemicals were added to the diet as a dietary supplement.
Prior occasional reports of responses in hepatitis C, 23 chronic fatigue/fibromyalgia, 24 and multiple
sclerosis had been received using only APM. Patients adding the new more complete micronutrients
required for cellular synthesis (nutraceuticals, designer foods, modem dietary supplements), reported
increased benefits. Anecdotal reports of restorative responses have became common for amyotrophic
lateral sclerosis, 2S inflammatory polyneutritis, Gulf War Syndrome and other suspected stealth virus
induced syndromes (unpublished reports and observations).
1996 a formulation containing APM and additional needed natural glyconutrient sugars was
formulated and a patent filed. 26 This dietary supplement of known necessary glyconutrients (KNG)
conforming to DSHEA regulations contained additional monosaccharides required in the endoplasmic
and golgi assembly steps to complete glycoprotein and glycolipid synthesis in human cells.
The consumption of the combination of glyconutrients, phytochemicals, phytogenins, and vitamins and
minerals in a natural matrix resulted in the reporting of an increased incidence of favorable responses, in
more advanced or terminal viral syndromes. This is dietary restoration through supplementation of
micronutrients low or missing in the modem food chain. Optimal cellular synthesis requires a supply of
all vital nutrients.
To demonstrate the increase in response to a full spectrum of micronutrient dietary
supplementation, two more recent cases of AIDS are provided. 27
Case H,
38 year old woman had on his initial clinic visit HIV-I with CD4s of 24/mm3 and elevated viral loads
by PCR, 2.2 million/nun3.
Case KL , 35 year old woman, had a CD41evel of 71 mm3 and 250,000 RNA pair per rom3.
Both added the current generation of necessary glyconutrients and micronutrients to their diets. Case H
was on his second non-effective triple drug cocktail and patient KL had refused all pharmaceutical
agents. Both responded with clinical improvements and now both have non-detected viral levels of
HIV-l vRNA by ultra-PCR. Patient H has CD4 assays ranging from 350 to 450 mm3 and KL has CD4
1evels currently consistently over 700 mm3.
In symptomatic HIV-I and asthma patients, the estimate is that the KNG formulation combined with
other micronutrients, pbytochemicals from plant matured fruits and vegetables, plant sterols of
Dioscorea origin, and vitamins and minerals in an enhanced bioavailable matrix, is 5 to 20 times more
bioactive than the original aloe polymannose alone. (personal observations in calculations in multiple
patients)
Individual Experiments or Experiences supportive of the use of glyconutrients combined with
other micronutrients to have a bioactivity to prevent infections, accelerate recovery and
ameliorate far-advanced microbiological toxic damage.
I.
Following reports of putative viral infection protection against influenza and the common cold in
humans, Research Biologics Institute, of La Grange, Texas, infected 20 cats using a nasal wash with
feline rhinotracheitis. Ten dietary intervention animals received 30 mg/Kg oral APM 6 hours before the
viral inoculation and the remaining half were virus infection controls, thus receiving no APM. In the
intervention leg that received APM, 8 had no symptoms, 2 had nasal discharge and red eyes for 2 days.
In the virus-infected controls, there was a 100% infection rate with severe URI symptoms and
pulmonary congestion. Nine subjects had symptoms for over 30 days. One animal died of pneumonia.
II.
Coach Bell of the University of Arkansas Women's track team reported that his team, using the
micronutrients to enhance physical performance, did not succumb to campus viral infections when the
student body was highly infected. The team performance was increased and set records, in the coach's
opinion, due the lack of having members experience conditioning and performance setbacks due to viral
and bacterial infections during the season.
III.
In Denver, Colorado, a mother reported that her 16-year old daughter had collapsed with gram negative
sepsis following an attempted self-induced abortion. Rapidly she was in coma, febrile, anuric,
unresponsive to pressor agents. At the end of the fifth hospital day the exhausted medical team
determined that the girl was no longer responsive to standard management and death was reportedly
expectant in minutes to a few hours. According to the mother, she started the administration of oral
APM powder with lecithin throughout the early evening and night placed the powder in her daughter's
mouth with small amounts of water. The next morning, as reported by the mother, her daughter
dramatically improved clinically, awakened, started producing urine and had stabilized blood pressure.
In less than a week she was dismissed with minimal residual disabilities.
IV.
In the summer of 2000 in Walkerton, Ontario, Canada, a toxic E. Coli epidemic hit due to contamination
of the city water system following extensive rains. A physician in family practice was taking the basic
Mannatech dietary supplements for muscular dystrophy with slowly progressive benefit Despite his
history of being the most susceptible to infections among members of his family, all his family members
experienced fever, cramping with bloody diarrhea and the doctor was spared any symptoms. He
instituted sharing his supply of dietary supplements with the sick family members and they rapidly
responded and within hours were symptom free with no residual toxic organ damage.
In the same community a nurse was taking the dietary supplements for a chronic unrelated health
problem. He daughter had the onset of symptoms typical of the epidemic including bloody diarrhea.
The mother did not get sick. The daughter was given the supplements and within a day was symptom
free. The daughter stopped the supplements as soon as there was an improvement. Within a few days
she had a return of symptoms that were alleviated rapidly by resumption of supplement intake. She
recovered without residual organ damage.
A local church in cooperation with a local doctor have over 15 cases that were managed by dietary
supplements and analysis of their response to assess response to glyconutritional supplement use. The
final report is pending.
V.
In Las Vegas, Nevada, an executive experienced multiple system collapse due to toxic shock syndrome
induced by. streptococcal toxin. He was febrile, in coma with pressor resistant cardiovascular collapse,
tachycardia, and the extremities were ischemic, cyanotic, cold and without pulses. Multiple medical
specialists declared the patient's condition as terminal and not reversible. By nasogastric catheter
administration of 1tps / hour bulk complete glyconutrient dietary supplement was initiated. His
physician reported that at 2 to 3 hours his limbs lost the bluish discoloration, became warm, and the
pulses returned. His general health improved dramatically and he was discharged from the hospital. To
date, the only major remaining residual is kidney dysfunction the need for renal dialysis each week. A
kidney transplant is anticipated. 28
VI.
In the role of medical director of Mannatech Inc., I have received at least 5 anecdotal reports of
multiple drug resistant bacterial infections that were life threatening. They followed major trauma or
surgery. They were identified to their family as terminal and on the addition of glyconutrients to their
nasogastric tubes there was a dramatic response and they were soon discharged from the hospital free
of fever, chills, and culture negative for their infectious bacteria. organism. In all cases the family
were Mannatech distributors or in communication with such distributors. There was an insistence on
administering the dietary supplements and despite resistance, the family prevailed under the critical
circumstances.
A somewhat similar report was received from a missionary in Africa regarding a small boy in clinical
collapse, maintained by intravenous fluids suffering reportedly with AIDS, multiple drug resistant
cavity producing tuberculosis and malaria. It was reported upon administration of the dietary
supplements, this moribund child responded remarkably well and again became active in the
community.
It should be noted that antibiotics attempt to inhibit, block, or poison biochemical processes within
infectious organisms in order to kill the tiny metabolizing microorganisms. Micronutrients and
especially glyconutrients work in a totally different manner. They support normal defensive
mechanisms. This is through the supply of nutrients essential for synthesis of the defensive molecules
that conduct or participate in natural defense and repair mechanisms. Such mechanisms are enhanced
and thus the invading organisms are destroyed and toxins, if produced, are neutralized.
Comment:
A.
The cases in which bacterial toxins were inflicting significant tissue damage requires mention of other
scientific knowledge regarding glyconutrients. As has been stated, Barhoumi, et.al. reported that in
liver cell cultures in 300 seconds (5 minutes) after the addition of aloe polymannose to the complete
culture medium, the intracellular level of reduced-glutathione was increased an average of 50% per
cell. It has been documented that in oxidative and free-radical damage initiated within cells, the
protective effects of intracellular reduced-gluthione and it synergy with outer antioxidant molecules is
vital (vitamin C, A, E, SOD, etc.) 29 It was documented that in virtually every illness and all symptoms
of an infirmity, regardless of how serious or minimal, the balance of intracellular oxidative and freeradical buffering capacity is altered. Thus, micronutrition and especially glyconutrients can potentially
provide a major potential mechanism of action for preventing and reversing endothelial cell damage in
patients with toxic shock syndrome, especially the damage expected in the re-perfusion phase of the
capillary bed associated with the characteristic cascade of free-radical endothelial cell damage and
vascular collapse that follows. Loss of non-wetability of the vessel lining endothelial cells is blocked.
Prevention of sludging of erythrocytes and plasma coagulation in the capillary bed and profound
acidosis and hypoxia found at the cellular level are ameliorated (M. D. Schlachter. M.D., personal
communications).
B.
There are multiple reports that highly charged, higher molecular weight complex carbohydrate,
glyconutrients, exhibit properties suggestive of chelating agents. Heavy metals and organic
petrochemicals 30 have been sequestered and removed ftom the body of known victims of
environmental toxin exposure with a long history of symptoms and disabilities. It is highly probable
based on human clinical responses, that bacterial toxins are also bound to the charged higher molecular
weight polymers of monosaccharides. These micronutrient molecules in the living plant, are found
extending from the cell surface. Bacterial toxins have an affinity to bind to surface cell membrane
glycoproteins. It is the sugar portion of this molecule extending from mammalian cells that acts as a
lectin site for the bacterial toxin binding. Thus, complex glyconutrients, derived from plant cell
membranes, would reasonably be expected to competitively bind bacterial toxin and spare membrane
damage in the infected host.
C.
Further evidence of the unique ligand activity of APM was reported by Azghani and Johnson.
Glyconutrient blocked pseudomoinduc adherence to pulmonary epithelium. Bacterial adherence is
required for pulmonary infection. This phenomenon could explain why that in cystic fibrosis children,
the addition of glyconutrients to their diets results in their becoming pseudomonas free with reduced
antibiotic prophylactic requirements.
D.
In addition, in the mid-1950s a search of the literature revealed that about 30 papers were published
demonstrating that the infusion of glucose to the extent that renal glucose spillage was detected,
pathogenic E. coli colonization and clearing of infection in the urinary tract was induced. We have an
anecdotal case report of a female with a 27 year history of progressive renal infection that cultured
positive for multiple bacterial organism species that were all multiple drug resistant There was
progressive renal tissue damage with deteriorating renal function. This infection rapidly cleared and
there has been restored renal function upon the persistent addition of micronutrient dietary
supplementation, with high amounts of glyconutrients to the diet. Her health has been totally restored
and her urine is now consistently sterile. (personal communication, last contact and verification,
11/2/01)
In conclusion, it is postulated that the use of glyconutrients added to the diet of individuals threatened
by imminent viral or bacterial pathogens will be protective. The extent of benefit realized following
exposure to infectious agents immediately after exposure to an infectious viral or bacterial has a
potential for benefit, but must be quantified and documented. It should be repeated that no
representation is made that the information provided is adequate for establishing national policy or
professional recommendations. It is strongly believed that further research has merit and that significant
advancements in management of
bioterrorist agents will be realized
H. R.McD November 14,2001
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2. McAnalley, BH, Carpenter, RH., McDaniel, H.R., U8 Patent 5,106,616, April 21, 1992.
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4. Kahlon, J.B., et.al., In Vitro Evaluation of the Synergistic Antiviral Effects of Acemannan in Combination with
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