challenge to the president, secretary of ... · web vieweditors of cell put the toronto researchers...

CHALLENGE TO THE PRESIDENT, THE SECRETARY OF VETERANS AFFAIRS, THE CONGRESSIONAL LEADERS

ON THE SENATE AND HOUSE VETERANS AFFAIRS COMMITTEES,

ALL CONGRESSIONAL LEADERS,AND THE BOARD OF VETERANS’ APPEALS

ON TOXIC CHEMICAL ASSOCIATIONS TO DISABLING CHRONIC AND PERSISTENT PERIPHERAL NEUROPATHY

(POLYNEUROPATHY)IN OUR VIETNAM VETERANS

04-03-2007

INFORMATION AND CHALLENGE COPIES TO THE NATIONAL ACADEMY OF SCIENCE INSTITUTE OF

MEDICINE

Several scientists and Congressmen in the 2000 Ranch Hand Oversight Review indicated they wanted to see other data that had not been

associated with the Department of Veterans Affairs or processed by one of the major government players.

HERE ARE THE FACTS!

of 114

THE UNITED STATES CAMPAIGNING “ARMY OF VIETNAM” AND ITS WIDOWS AND ORPHANS

DESERVE “DEEDS”

NOT “WORDS” FROM OUR GOVERNMENT

1

1

of 114

ABSTRACT: CHRONIC PERIPHERAL NEUROPATHY ASSOCIATED WITH EXPOSURES TO THE DIOXIN, TCDD DURING WARTIME SERVICE BY OUR VIETNAM VETERANS.

In order to determine the ‘VALIDITY’ of legal statements from the Secretary of the Department of Veterans Affairs and the ‘VALIDITY’ of the works of the National Academy of Science Institute of Medicine (NAS/IOM) regarding Chronic Debilitating Peripheral Neuropathy found in Vietnam Veterans, a four-year data search and analysis was completed.

It was found, during this search and analysis, associations to dioxin exposures and peripheral neuropathy were ‘statistically significant’ and demonstrated ‘a proven increased risk of incidence’ with an Odds Ratio of at least OR =2.39. P values of dioxin association were found at < p - 0.050 and P values of significant differences at p - 0.0042.

In the Ranch Hand study used as the Government’s “Gold Standard Study of Denial,” the statistics were not available. Evidence did find many associations in different yearly scientific transcripts and statements by Dr. Joel Michalek (one of the leaders on the Ranch Hand Study)"... WE CONSISTENTLY FOUND A STATISTICALLY SIGNIFICANT INCREASED RISK OF ALL INDICES OF PERIPHERAL NEUROPATHY AMONG RANCH HAND VETERANS.”

During this study and analysis, it was found that government processes used in determining “presumptive associations” were non-determinable as to qualification and quantification. The evidence found bordered on “scientific misconduct” and the lack of “scientific intellectual freedom.”

During this study and analysis Veterans did not find the CONGRESSIONAL MANDATED BENEFIT OF THE DOUBT GIVEN AT ANY LEVEL OF GOVERNMENT DECISIONS IN THESE UNKNOWN TOXIC CHEMICAL DAMAGES.

Definition of a “Gold Standard Study”:

Meaning - the most predominant and thought to be the leader in scientific evaluations with the best, opportunity to discover and document what the study was design to find in science and statistical data. Other studies, both national and international, use the gold standard study to evaluate what their studies found in comparison.

2

2

of 114

In the world of electronic parts this would be called a "gold nugget" where the gold nugget part defines all parameters and operational characteristics of all other parts that follow - all parts are then measured and/or compared to the gold nugget. The gold nugget is used to set testing parameters and verify test equipment, etc.

3

3

of 114

02 April 2007 TO: The President, Senators, Congresspersons, Congressional Staff Members, Department of Veterans Affairs, and the National Academy of Science Institute of Medicine, and those individuals/news agencies listed on pages 79 to 82. FROM:Please respond to: Charles Kelley2078 Eastwood Drive,Snellville, GA [email protected]: 404-641-6477

SUBJECT: The GOVERNMENT CONTROLLED and funded RANCH HAND STUDY of mortality and morbidity impacts to Vietnam Veterans and their families based on NAS/IOM and Department of Veterans Affairs decisions regarding chronic and persistent Polyneuropathy found in these Veterans. This NOTICE OF DISAGREEMENT and NEW evidentiary scientific and medical data is submitted on behalf of:

ALL VETERANS OF THE VIETNAM ERA WITH DIAGNOSED CHRONIC AND PERSISTENT POLYNEUROPATHY

Toxic Chemical Issues and cumulative evidentiary data compiled by Charles W. Kelley

Veterans Agent Orange Lay Expert.

Author of “Vietnam’s Rain Agents Orange, White, and Blue (Weapons of Mass Destruction”)

http://www.2ndbattalion94thartillery.com/book/bookorders.htm

4

4

http://www.2ndbattalion94thartillery.com/book/bookorders.htm

mailto:[email protected]

of 114

CONTENTS

VETERANS' STATEMENTS pages 6 - 8

OVERVIEW pages 9 & 10

LOGIC pages 11 - 15

EVIDENCE pages 16 - 53

THE GOVERNMENT SLIPPERY SLOPE pages 54 - 65

SUMMARY pages 66 - 73

CONCLUSIONS pages 74 - 76

RECOMMENDATIONS pages 77 – 78

THOSE LISTED pages 79 - 82

REFERENCES pages 83 - 86

DEFINITIONS pages 87 - 97

MEDIA REPORTS pages 98 - 113

5

5

of 114

VETERANS' STATEMENTS

The Veterans shall establish SCIENTIFIC, STATISTICAL, and MEDICAL EVIDENCE demonstrating that their diagnosed condition is “AT LEAST AS LIKELY AS NOT” medically associated with dioxin, TCDD exposures and/or the other toxic chemicals involved in WARTIME SERVICE that caused the degenerating nerve conditions.

The Veterans shall establish that “IT IS AT LEAST AS LIKELY AS NOT” that a CHRONIC AND PERSISTENT POLYNEUROPATHY diagnosis is well connected to WARTIME SERVICE IN VIETNAM. In association to presumptive and/or known exposures to the toxic chemicals in the herbicides AGENT ORANGE, AGENT WHITE or AGENT BLUE and/or a combination of all three or in any of the other known 15 toxic chemicals that were used during the Vietnam War by the UNITED STATES GOVERNMENT. There is a variance in toxicity from 1.7 parts per million to 70 parts per million of the dioxin, TCDD.

(NOTE: Comparative evaluation of toxicity = the entire town of Times Beach, Missouri (CIVILIANS) was evacuated because of pooled stock at <2 parts per million. (1)

The Veterans shall establish a well-grounded claim by submitting competent medical and scientific evidence demonstrating that the current diagnosed “CHRONIC AND PERSISTENT POLYNEUROPATHY” is related to not only AGENT ORANGE HERBICIDE EXPOSURE but also many of the other toxic chemicals to which he/she was exposed. (Brock v. Brown, 10 Veterans Appeal 155 (1997). (McCartt v. West, 12 Veterans Appeal 164 (1999).

The Veterans shall establish THE DEPARTMENT OF VETERANS AFFAIRS along with the government contracted NAS/IOM’s statements and findings that ONLY “TRANSIENT ACUTE AND SUBACUTE PERIPHERAL NEUROPATHY” is associated to WARTIME SERVICE in a dioxins and dioxin- like isomer toxic chemical environment IS ERRONEOUS and BASED ON FAULTY SCIENTIFIC CONCLUSIONS AND ASSUMPTIONS.

The Veterans shall establish THE RANCH HAND STUDY used by the government entities as a “GOLD STANDARD STUDY” to deny such nerve damage and many other Vietnam Veterans mortality and morbidity is flawed in its assumptions of the “exposed” versus “not exposed” study groups.

6

6

of 114

[Medical issues and disorders found at what was determined on THE LOW-END OF SIGNIFICANT being used by our government that somehow does not meet relevancy is a MAJOR PREMISE FLAW in the GOVERNMENT’S GOLD STANDARD used to deny morbidity and mortality. This known flaw would badly SKEW towards the denial of such relevant findings. A LOW END OF SIGNIFICANCE FINDING could certainly reach relevancy of a significant finding, increased risk of incidence, or significant correlation.]

{In the words of one of the major Ranch Hand Scientists, employed by the Department of Defense, Dr. Joel Michalek, "It's as if you're running a clinical trial on a new medication, and you found out some of the people who were in your placebo group were actually taking meds. That would spoil your whole study. And that's what's going on here in this study."}

The Veterans shall establish that “a dioxin isomer” is never found alone.

Isomer Definition: {A chemical species with the same number and types of atoms as another chemical species but possessing different properties.}

Government studies used as “GOLD STANDARDS” that mandate for sampling of a single dioxin isomer IS OF LITTLE VALUE when considering the possible outcomes in medical causations the Veteran may suffer disability or death from mixed dioxin compound isomers or dioxin like isomers in the form of furans and/or polychlorinated biphenyls (PCB’s).

The Veterans Shall establish that protocol violations with regard to many medical issues found increased at over a 50% increase were not pursed as relevant findings because of a mandated linear increase to the single dioxin, TCDD was not met. This mandate was a seriously flawed mandate to dioxin linear increase to the medical disorders when no detrimental linear increase had been detected or proven in all medical issues.

The Veterans shall establish that BECAUSE OF THE PRECEDING GOVERNMENT MANDATE, many disorders found as "SIGNIFICANT CORRELATION" and/or "INCREASED RISK OF INCIDENCE," some greater than a 50% cohort increase in comparisons, are not being brought forward. This has resulted in the Veteran via the Veterans doctor a fair assessment of his/her health because of government wrong doing and mistakes in toxic chemical exposure studies, evaluations, and statistical analysis.

The Veterans' claims are being denied by the DEPARTMENT OF VETERANS

AFFAIRS because of “SERVICE CONNECTION” based on exposure to herbicides in Vietnam is not warranted for any conditions - other than those for

7

7

of 114

which “VETERANS AFFAIRS HAS FOUND” a positive association exists between the condition and such exposure.

(Our Government and Department of Veterans Affairs on behalf of the White House are too stringent in mandates and opposed to their own previous standards, court orders and rulings, and outside the realm of current science, as it exists today.)

The Board of Veterans Appeals is inconsistent in rulings on “CHRONIC AND PERSISTENT POLYNEUROPATHY.” Some cases are identical except for the Veterans name with diverse outcomes. Awards are diverse and opposite to include boards rational for denial. Some board rational states The Department of Veterans Affairs has found “CHRONIC AND PERSISTENT POLYNEUROPATHY” is not associated to dioxins or wartime service in Vietnam and others state; Congress has found “CHRONIC AND PERSISTENT POLYNEUROPATHY” is not associated to dioxins or wartime service in Vietnam. (Neither are experts in toxicology!)

The Veterans further claim; the statements that deny CHRONIC

PERSISTENT POLYNEUROPATHY made by the Secretary of Veterans Affairs, VA scientists, and NAS/IOM scientists are baseless as they are not experts in either the immunotoxicity issues of toxic chemicals (dioxin/furan toxic chemicals) or the resulting dioxin created autoimmune disorders that develop many forms of neuropathies.

The Veterans further state that the evidence and facts provided herein

demonstrate that the chronic and persistent polyneuropathy disorder should be an “automatically associated presumptive disorders.”

8

8

of 114

OVERVIEW The Board of Veterans Appeals (BVA) and the Secretary of the Department of Veterans Affairs are “inconsistent” in statements of fact of the requirements for the Veteran to prove service connection. Many studies have shown association of neuropathies that meet the Veterans Affairs own requirements of such studies. (See 38 C.F.R 1.17 “Evaluation of studies relating to health effects of dioxin and radiation exposures.”) Veterans Affairs and the BVA mandate positive association on exposures to “herbicides.” Then mandates the Veteran prove “dioxin, TCCD” associations.

The Veterans disagree with the Veterans Affairs and/or BVA that all such medical associations in claims during a toxic chemical environment must be addressed/associated to the one single by-product of the manufacturing process of (2, 4, 5 trichlorophenoxyacetic acid; 545.4 Kg/m3) {2,4, 5-T} producing the dioxin, TCDD with that being impure Dioxin (2, 3, 7, 8-tetrachlorodibenzo-p- Dioxin) {2,4,5-T}. Veterans state that the dioxin, TCDD is a “single toxicant” of a “single component” that made up the single herbicide with the government nomenclature of “Agent Orange.” There were more toxic chemicals in Agent Orange than Dioxin alone (2, 3, 7, 8-tetrachlorodibenzo-p- Dioxin) since Agent Orange was a 50/50 mixture of (2, 4, 5 trichlorophenoxyacetic acid; 545.4 Kg/m3) {2,4, 5-T} and 4:1 of 2, 4-D (2, 4-dichlorophenoxyacetic acid; 239.7 kg/m3) and Picloram (4-amino-3, 5, 6-trichloropicolinic acid; 64.7 kg/m3). The additional 50% mixture of this toxic chemical cocktail had its own set of toxic chemical causations. Picloram was a “convenient” Dow Chemical Corporation proprietary formula. To this day, neither Veterans nor the world science organizations know what made up this formula and the toxicity levels at the time of Vietnam Veterans exposures. (See Page 19 Statements by Dr. Daniel Teitelbaum, MD) BVA and its members need to be cognizant and knowledgeable to the scientific facts that there is no such thing as “a” dioxin. There are over 200 dioxins that are part of a family of “co-planer” toxicants, which includes dibenzofurans and polychlorinated biphenyls (PCB’s) and are rarely found alone, if at all, with just a single dioxin isomer. The facts are - that in science and toxicology the most carcinogenic of all the dioxins, dibenzofurans, and polychlorinated biphenyls (PCB’s) is (2, 3, 7, 8-tetrachlorodibenzo-p- Dioxin) {2,4,5-T} found in Agent Orange. Science compares the carcinogenic severity of other dioxins, dibenzofurans, and polychlorinated biphenyls (PCB’s) to the dioxin, TCDD that “is” quantified and qualified as the worst. The key words are “carcinogenic severity of other carcinogens in this family of toxic chemicals.” Therefore, it is logical the Veteran would not only be exposed to the single toxicant of one component but many toxicants of the many components that make up the “Herbicides.”

9

9

of 114

Veterans are in disagreement with THE CURRENT ACUTE AND SUBACUTE TRANSIENT PERIPHERAL NEUROPATHY CONCLUSIONS by the Department of Veterans Affairs as well as the NAS/IOM which is contracted by the same government agency the Veteran is now seeking disability compensation from on the issues of CHRONIC PERIPHERAL NEUROPATHY and those disability issues normally associated with this chronic degenerating nerve disorder. At issue is the present Department of Veterans Affairs and the government contracted Institute of Medicine (IOM) positions on CHRONIC PERIPHERAL NEUROPATHY. It is biased, scientifically flawed, and assumes integrity of studies conducted by our government that are flawed not only in science but statistical evaluations based on flawed cohort exposure levels and the use of a changing Exposure Index.

10

10

of 114

LOGIC

On May 23, 1991, the VETERANS' ADVISORY COMMITTEE ON ENVIRONMENTAL HAZARDS (VACEH) considered the relationship between exposure to dioxin and the development of this condition. The Committee concluded that there is a "SIGNIFICANT STATISTICAL ASSOCIATION" BETWEEN “PERIPHERAL NEUROPATHY” AND EXPOSURE TO DIOXIN.

To understand this VACEH decision and the resulting illogical VA and NAS/IOM decisions that made this statistical finding “null and void” for the Nations Disabled Vietnam Veterans, one must consider the facts.

Peripheral Neuropathy, sometimes referred to as Polyneuropathy, is a generic term that describes many pathological damages of the lipid nervous system components within the body and the three major areas of the nervous system. (See Complete Definition of Peripheral Neuropathy at the end of this Veterans Challenge.)

There are hundreds of diagnosed forms of Peripheral Neuropathy having singular or overlapping remarkable pathological findings. Some of these have remarkable and International Codes of Diagnostics (ICD) matched disorders associated with them. In some cases, the Peripheral Neuropathy remains idiopathic and may be only a symptom of a more egregious subclinical developing dioxin caused disorder(s) or variants of a disorder.

Many of our Nation’s most prestigious research hospitals such as Harvard Medical School has concluded that 33% of all cases of Peripheral Neuropathy will remain idiopathic with no ICD parallel testing evaluation and conclusion as to causation. The peripheral neuropathy symptoms may remain idiopathic for life or may be attributed to but not conclusive to some found testing disorders that have no ICD equivalent medical world conclusion, i.e. a variant of a disorder that is not conclusive.

For autoimmune neuropathies, diagnosis is vague due to a lack of generally accepted clinical diagnostic criteria. Vietnam Veterans with autoimmune neuropathies are diagnosed as having “idiopathic neuropathy” despite the disabling progression of their disease. On the other hand, they may have a diabetes involvement, which is automatically associated to the diabetes, rather than the dioxin caused blood disorders, immunotoxicity or even the dioxin itself at that point in the Disabled Veterans progression, subclinical central nervous system damages.

11

11

of 114

There are many forms of neuropathic conditions and many will overlap the conditions, findings, and remarkable demonstrations of such variety of symptoms. This logically would conclude more than one pathology; therefore, it would be associated to various types of testing in Hematological Disorders, Immune System Disorders, Central Nervous System Disorders, etc. At this point in the state of science and medicine, the “more than likely” associated disorder may find overlapping causations of the different body systems and systemic damages none of which reaches any conclusion other than testing anomalies found. However, none equate to an ICD disease or disorder in total. In many cases, these testing disorders remain subclinical and only the highly specialized diagnostics scientists can determine that underlying subclinical disorders are even suspected based on what neuropathic conditions are demonstrated.

In some of these areas, in order to understand the pathology, different treatments are tried to an effort to understand the possible underlying systemic issues. If one treatment gives even temporary relief then by that alone the researcher can conclude a possible direction and subclinical cause.

The identified major category disorders normally associated to neuropathic conditions are:

Central Nervous System Damages

Liver Enzyme Issues

Elevated antinuclear antibodies (ANA)

Immune System Damages or Dysregulation

Hematological Disorders

Diabetic and non-diabetic – insulin resistance

Cancers

Smoldering Cancers

Benign forms of cancer development

Vasculopathy Issues and Disorders

Elevated C-reactive protein should also be tracked in parallel with Lipid panels for vascular inflammatory involvement in monitoring disease progression and as a surrogate marker in treatment studies.

Stroke Conditions or cerebral dementia indicators.

12

12

of 114

Lipid Metabolism Disorders/ Metabolic Syndrome (seems to be especially correlated to increased triglycerides of a level above 150 mg/dl)

All of the preceding conditions have been found in studies associated with dioxins including the Ranch Hand Study.

Increased triglycerides found associated to dioxin, TCDD in the Ranch Hand study early on (13a) absent the normal associated markers associated certainly could have pointed out the developing associated neuropathic issues.

Increased Gamma Glutamyltransferase (GGT) liver enzyme level was found dioxin level dependant in Ranch Handers. (13b) Gamma Glutamyltransferase is associated with many disorders Vietnam Veterans have developed including neurological issues such as Peripheral Neuropathy and more. What the scientists concluded in not bringing this dioxin linear finding forward will be covered in the section on “The Government Slippery Slope.”

In diabetic conditions the present established types are:

Type I – associated to autoimmune issuesType II – associated with old age or aging

Science now concludes there are variants of Type I as in Type Ia.

Another new category Type III has no effects on blood sugar but influences brain insulin levels.

Recently we find that Type I and Type II may be closer as to the same causation as previously scientifically thought. Type I considered an autoimmune diseases whereas Type II was considered an aging issue. Recently in tests, they found these types might be associated to autonomic sensory nerve damage in the pancreas insulin islets; including insulin resistance. (See Evidence Section). {For the Vietnam Veteran, toxic chemically exposed at government high rates and high doses, instead of the “normal,” or what is looked at as clinical progression of: diabetes > neuropathy. It might very well be: and associated dioxin causations and neuropathic disorders > diabetes development.}

Autoimmune disorders are numerous and widespread with many variants under the one ICD category of a single autoimmune disorder, of which can be associated to neuropathic conditions, in part or in total.

The following statement as well as the findings of the many other studies referenced in the “Evidence Section” of this challenge including statistical significant p- values and Odds Ratios found.

13

13

of 114

The Committee concluded that there IS a "significant statistical association" between “peripheral neuropathy” and exposures to dioxin.

“The VACEH scientific statement” does not conclude or qualify that dioxin directly caused the Peripheral Neuropathy. The statement DOES CONCLUDE that the data analysis reveals Peripheral Neuropathy Development IS found associated to exposures to dioxin. It infers no pathological reasons or pathological system issues directly. Only that systemically the data shows a found statistical association to development of Peripheral Neuropathy associated to dioxin exposures, regardless of pathology - clinical or subclinical!

As anyone can plainly see in the above VACEH statement, this was made 16 years after the last Veteran left Vietnam. The other studies cited in the Evidence Section were also completed in the 1990’s and even later, including the governments own found associations in the Ranch Hand Study to dioxin exposures and to development of Peripheral Neuropathy. Yet, according to the NAS/IOM and the Secretaries of Veterans Affairs, the now physically Disabled Veterans have been legally compromised by the VA court system by their statements of:

“Must manifest “within one year of Vietnam” and the Neuropathy must resolve within two years of that one year of removing the Veteran from the toxic chemical environment.” By those statements, Peripheral Neuropathy in our Vietnam Veterans should no longer exist and certainly, “should not have been found associated to dioxin exposures” decades after our toxic chemical exposures by our own government analysis and our own government studies.

Clearly, this is not a science mandate or the studies mandates due to findings, including the governments own Gold Standard, and are all totally wrong and totally scientifically inept, scientific misleading, and therefore scientifically fraudulent.

It should be pointed out, this statement as well as other study findings was made many years prior to any diabetic pronouncement, which in some scientific circles today are still questionable as to the direct dioxin causations. (Clearly if there is a paradigm shift in Diabetes Type II causations regarding sensory nerve damages then of course this questionable causation would be alleviated. More importantly, it would just add scientific credence to what is discussed in this challenge regarding neuropathy disabilities of our Vietnam Veterans.)

The facts are clearly demonstrated “with or without a diabetes diagnoses” that Peripheral Neuropathy development, regardless of pathology, are associated to dioxin and dioxin isomer like exposures.

14

14

of 114

The Board of Veterans Appeals has and continues to adjudicate case decisions based on NAS/IOM statements and those of the Secretaries of the Department of Veterans Affairs in overriding Vietnam Veterans claims.

Veterans are legally correct by the preponderance of the scientific evidence“it is as least as likely as not” that their debilitating Peripheral Neuropathy conditions are a result of dioxin, TCDD and/or other toxic chemical exposures during WARTIME SERVICE IN THE REPUBLIC OF SOUTH VIETNAM.

Idiopathic - Any disease or disorder that is of uncertain or unknown origin.

15

15

of 114

EVIDENCE It is imperative that all recipients of this challenge know and understand the history of this Peripheral Neuropathy (nerve disorder), its association to toxic chemicals, and the wide variety of biases against this Nation’s Vietnam Veterans while the Department of Veterans Affairs uses and abuses VA using the power it has in 38 C.F.R paragraph 1.17. This section allows the Secretary to provide “guidelines for establishment of service connection” then systematically minimizes the effects and costs of the nerve disorder to make baseless, presumptuous, and erroneous decisions. On May 23, 1991, the VETERANS' ADVISORY COMMITTEE ON ENVIRONMENTAL HAZARDS (VACEH) considered the relationship between exposure to dioxin and the development of this condition. The Committee concluded that there is a "SIGNIFICANT STATISTICAL ASSOCIATION" BETWEEN “PERIPHERAL NEUROPATHY” AND EXPOSURE TO DIOXINS. The Committee qualified this opinion, stating that the association could be said to exist in the absence of exposure to chemical substances known to cause this disorder. The Committee members indicated that other risk factors that must be considered are age and whether the individual suffers from other known causes of peripheral neuropathy such as diabetes, alcoholism, or Guillain-Barre syndrome. The Committee also advised that the disorder must become manifest within “ten years” of the last known dioxin exposure. The VACEH’s statements CONFIRM:

A FOUND SIGNIFICANT STATISTICAL ASSOCIATION BETWEEN “PERIPHERAL NEUROPATHY” AND EXPOSURE TO DIOXINS. The VACEH Committee, in restating the “medically obvious” to even the first year medical student, stated that associations to other disorders such as alcoholism, Guillain-Barre, or diabetes also may cause peripheral neuropathy. This statement no matter how medically and scientific inept and not even germane to the subject of the stated found associations directly to Peripheral Neuropathy and dioxin exposures should not be used as a qualifying statement against the Veterans.

Guillain-Barr syndrome. Guillain-Barre syndrome may be an autoimmune disorder in which the body produces antibodies that damage the myelin sheath that surrounds peripheral nerves. The myelin sheath is a fatty substance that surrounds axons. Veterans would also add variants of the Guillain-Barre Syndrome, as there are variants of this disorder that do not meet the ICD

16

16

of 114

diagnostics in its entirety and conclusion. This seems to be true in the axonal variant of Guillain-Barre. Idiopathic SENSORY AXONAL CHRONIC PERIPHERAL NEOURPATHY seems to be the most common diagnosis in our disabled Vietnam Veterans with the accompanying manifestations. Some with chronic peripheral neuropathy have gone on to a more serious diagnosis of Multiple Sclerosis (MS), Parkinson’s, or Amyotrophic Lateral Sclerosis (ALS) nerve damage. Whether Central Nervous System Damage (CNS) or Peripheral Nervous system (PNS), it still equates to TOXIC CHEMICAL NERVE DAMAGE, which must include those nerve functions that operate autonomic and autonomous.

(There is an ongoing battle within the scientific community as to whether a subclinical CNS damage is usually present before clinical PNS damage takes place.)

THE EPA REASSESSMENT OF DIOXIN STATES: (2)

The EPA has concluded that dioxin is more dangerous than previously thought, even at extremely low doses. It accumulates in the body fat and once in the body, even at very minuscule amounts, interferes with cell development.

The “brain may be particularly vulnerable” to accumulating dioxin into its fat content. Nervous system tissue itself, with its high lipid content, can also act as a repository for dioxin.

Dioxin is now known to interfere with the most delicate balanced biological process in the body.

The EPA also emphasized that dioxin damages the immune system directly and indirectly. This is the worst of all immune damage scenarios.

With this finding in the toxicology scientific community on dioxin/brain involvement with its high lipid content, (as well as the spinal chord tissues with its high lipid content), all subclinical CNS issues must be a consideration in part of any diagnosis of idiopathic symptoms that normally are associated with some form of CNS damages. Medically bearing in mind, the Vietnam Veteran is a toxic chemical victim of many forms and types of toxicity exposures.

With the state of medicine and science, as it exists today exposures to dioxin do in fact create antibody problems as well as cytokine problems that direct autoimmunity in many different ways and communication levels. To say this disorder could not produce what is called AUTOIMMUNE NEUROPATHIC CONDITIONS would not only be spurious at best but very unscientific. (See Evidence Section - Immune system)

17

17

of 114

The VACEH clearly stated as part of its function (supposedly on behalf of the Veterans) the “FOUND SIGNIFICANT STATISTICAL ASSOCIATION" BETWEEN “PERIPHERAL NEUROPATHY” AND EXPOSURE TO DIOXIN and then qualified that with a non-proven and non-justified “ten-year time limit.” Next, the Secretary of Veterans Affairs immediately changed the time limit to a “one-year time limit” all but making the government pronouncement of association useless and by doing so; it now denied all neuropathic conditions in our Vietnam Veterans associated to the dioxin, TCDD exposures.

The fact, that one scientific pronouncement can go from a 10 year associations to a one year association by the stroke of pen should tell all who are receiving this Challenge how ridiculous this finding was manipulated and subjected to Government yearly budget mandates not science and certainly not the facts. (This exclusion might well have been 1460 and one-half day’s exclusion, which would make about as much sense.) To qualify the development time of any disorder associated to dioxins, including Peripheral Neuropathy, one must understand the medical etiology (pathology) of how dioxin creates the found statistical association of the condition. All the pathological roads must be identified. As in many cases, there is more than one pathological pathway of causations related to dioxins and furans. In addition, the discussion must now turn to threshold and/or ingestion rate in order to quantify a time limit. Different forms of ingestions have different rates of body absorption. None of these are known today much less in 1991 when the 10-year time limit turned into a one-year time limit. Therefore, the qualifying and the other inept statements, other than the found statistical association to Peripheral Neuropathy and/or dioxin created medical conditions, ARE NOTHING MORE THAN “VA/GOVERNMENT SCIENTIFIC MISCONDUCT” LINKED TO BUDGET CONSTRAINTS; NOT SCIENCE. In other words, the health and welfare of the Vietnam Veterans was negatively affected by an edict by a government agency (VACEH) and then changed by the Secretary of Veterans Affairs (Mr. Derwinski) to save money and the other associations that may then be associated to neurological damages. It is impossible to know when “the last dioxin exposures occurred in the Vietnam Veteran” no matter where he/she resided after the war. It is well known that most of the world’s population including the United States is exposed to some level of dioxins and/or dioxin like isomers especially since industrialized nations continue to pollute the environment. The questions have always been; what types of harm do these ingestions cause, what form of ingestions are at risk, what rate of ingestions are at risk, or what cumulative body threshold over time is required to cause some form of systemic damage to organs and/or body operating systems or a malignant/benign cancer conditions. The Environmental Protection Agency (EPA) in its reassessments of dioxins clearly stated that dioxin ingestions must be thought of as “cumulative lead ingestions.” (3) Having many subclinical long-term effects before the damage is discovered or

18

18

of 114

manifestations began. To even suggest that “only the Vietnams Veterans exposure” to dioxin or the other dioxin-like furans would or could be the reason for a given low-end of significant finding is not only wrong spirited but against all scientific logic of how these cumulative toxicity issues occur.

To the contrary, their exposures to dioxin and dioxin-like furans of super government toxicity and super increased dose rates should be considered a life catalyst for any and all disorders connected to such toxicity. These medical conditions must be considered and described as related to degenerating conditions suffered later in life, which VA and NAS/IOM, with no evidence to the contrary, continually deny. Therefore, the government/VA stand on any “time limit” to manifestations of “any disorder” is totally without merit or Scientific precedence regarding an unknown toxic chemical and/or a group of unknown toxic chemicals that can have a cumulative effect not only in body accumulation but systemic damages that occur because of additional exposures over life is unacceptable and should be corrected. Government decision makers and especially Congresspersons and Senators must know or become aware that these dioxins and dioxin-like furans remain in the body attached to more lipid cells (fat) and only degrade in toxicity at a rate of seven to ten years of half-life. It should also be noted that our nervous system tissues are about 70% - 80% lipids and the rest is protein. In dioxin reassessment reports, EPA identified 18 major U.S. Dioxin Sources. (3) It should be noted that one of the identified sources of major dioxin contamination was the toxic chemical 2, 4, -D. Those familiar with the Vietnam Veterans Toxic Chemical Legacy may recall that 2,4-D was not only used as a separate herbicide with the nomenclature Agent White but also used as a 50/50 mixture within the herbicide with the nomenclature Agent Orange. In fact the most widely used dioxins containing herbicide chemical was Agent White and not Agent Orange. Agent White was the code name for a mixture of an approximate ratio of 4:1 of 2, 4-D (2, 4-dichlorophenoxyacetic acid; 239.7 kg/m3) and Picloram (4-amino-3, 5, 6-trichloropicolinic acid; 64.7 kg/m3), which was used from 1965 to 1971. The toxic chemical 2,4-D is also noted for attachment to more lipid cells as a repository. The Herbicide with the nomenclature Agent White (2,4-D) also had other dioxin isomers as well as closely related furans, which was also used separately, and as a 50/50 mixture with Agent Orange.

In the context of evaluating Agent Orange after having reviewed Dow Chemicals own documentation, Daniel Teitelbaum, MD, one of the world’s foremost toxicology experts was concerned about Agent White. A letter written to Admiral Elmo Zumwalt during the 1989 assessment stated: (4)

“What I do think...may bear on the Agent Orange issue, is the fact that in review of Dow’s 2,4-D documentation I found that there are significant concentrations of

19

19

of 114

potentially carcinogenic materials present in 2,4-D which HAVE NEVER BEEN MADE KNOWN TO THE EPA, FDA, OR TO ANY OTHER AGENCY. Thus, in addition to the problem of the TCDD which, more likely than not, was present in the 2,4,5-T component of Agent Orange, the finding of other dioxins and closely related furans and xanthones in the 2,4-D formulation was of compelling interest to me.”

Picloram is a convenient Dow proprietary chemical formula that contained not only nitrosamines but also a form of benzene toxic chemical known as hexachlorobenzene. Which would almost guarantee this formula would have other dioxins and dioxin-like isomers. For example: Any of the hexachlorodibenzofuran isomers, hexachlorodibenzo-p-dioxin isomers, tetrachlorodibenzofuran isomers, tetrachlorodibenzofuran –p-dioxin, pentachlorodibenzofuran isomers, or pentachlorodibenzo – p-dioxin isomers It should be noted that the benzene family of toxic chemicals also cause hematological disorders, including leukemias. Nitrosamines are carcinogenic chemicals that are known to cause cancers and other medical problems. Exposure to high concentrations of nitrosamines is associated with increased mortality from cancers of the esophagus, oral cavity, and pharynx. When used in pesticides or herbicides they may cause DNA damage and cell death.

In 1985, the EPA ruled that in order for DOW Chemical to gain re-registration of Picloram, it had to reduce its contamination to less then 200 parts per million (ppm) for Hexachlorobenzene, and less then 1 percent for Nitrosamine. Dow has reduced Hexachlorobenzene and now has no (zero) Nitrosamine in Picloram. The toxic chemical levels used on Vietnam Veterans in the created militarized herbicides are unknown at this time. This is due in part to the chemical company and government convenient amnesia.

The specific reasons and rational for the re-qualification of Picloram requiring the reduction of Hexachlorobenzene and Nitrosamines seem to be conveniently lost in EPA history. Could the reason have been the medical issues the Vietnam were developing caused some concern? Certainly, the time line of concern would have been appropriate.

One can readily see that the government mandated to a “cause and effect” of the one-dioxin isomer, TCDD is illogical given the toxic chemical environment in which the Vietnam Veterans served. To mandate one medical disorder or a group of medical disorders from mixed dioxin compound isomers or dioxin-like isomers in the form of furans and/or polychlorinated biphenyls (PCB’s) is outside the realm and ability of science, as we know it at this time. We cannot recreate the Vetearns Toxic Chemical

20

20

of 114

Legacy in order to ferret out which toxic chemcial or what combination of toxic chemicals may have caused which specific disorder and/or cancer.

The above White House directed philosphy over the course of serveal presidental terms has mandated undue hardship on the Veterans of This Nation that served in the government created toxic chemicals environment. Veterans Affairs and U.S. Government studies have concentrated solely on the worst dioxin that being 2, 3, 7, 8-tetrachlorodibenzo-p- Dioxin found in 2, 4, 5-T or, Agent Orange. Clearly, there are other dioxins, xanthones, and closely related dioxin-like furan isomers that have never been looked at, identified, or even a Veterans Affairs/Government concern expressed in over 40 years. It is further stated by the Vietnam Veterans the Herbicide with the nomenclature Agent Blue cacodylic acid (dimethyl arsenic acid) symptoms include: (5) Acute exposure may lead to:

Garlic type odor of breath and feces, and metallic taste in the mouth. Adverse GI effects predominate with vomiting, abdominal pain and rice-water,

or bloody diarrhea. GI effects may also include inflammation, vesicle formation, and eventual

sloughing of the mucosa in the mouth, pharynx, and esophagus. Central nervous system effects that are common include: headache, dizziness,

drowsiness, and confusion. Symptoms may progress to include muscle weakness, spasms, hypothermia,

lethargy, delirium, coma, and convulsions. Renal injury manifests as proteinuria, hematuria, glycosuria, oliguria, and

shows up in the urine. In severe poisoning cases, acute tubular necrosis results. Cardiovascular effects include shock, cyanosis, and cardiac arrhythmia. Elevated liver enzymes and jaundice may manifest causing liver damage. Injury to blood-forming tissues may cause anemia, leucopenia, and

thrombocytopenia.

Chronic exposure may lead to:

Muscle weakness, fatigue, anorexia, weight loss. Hyperpigmentation, hyperkeratosis. Peripheral neuropathy, paresthesia, paresis, and ataxia. Inability to coordinate voluntary muscular movements. Subcutaneous edema in face, eyelids, and ankles. Stomatitis, white striations across the nails (Mees lines) and sometimes loss of

nails or hair. Liver toxicity as indicated by hepatomegaly, jaundice, and cirrhosis. Renal toxicity leading to oliguria, proteinuria, and hematuria. EKG abnormalities and peripheral vascular disease.

21

21

of 114

Hematologic abnormalities. Cancer.

Carcinogenicity has not been tested adequately, but it should be noted that other inorganic arsenic compounds have been found associated with liver, lung, skin, and stomach cancers.

While not in the dioxin family Agent Blue cacodylic acid (dimethyl arsenic acid) certainly has toxic chemical properties according to our own U.S. EPA. (5) In 1969, the U.S. State Department became involved in analyzing and minimizing the effects that were being seen in our Vietnam Veterans. The State Department clearly indicated in a report that Agent Orange was of very little concern. While Agent Blue with its arsenic acid base “was a real concern.” (6) These toxic chemical effects and possible outcomes simply cannot be just government ignored because Agent Blue was not as widely used as Agent White or Agent Orange. There were very few areas of Vietnam where only Agent White and Agent Orange were used and not Agent Blue. In some cases, some firebase areas received more Agent Blue than Agent White.

In a newly declassified document called ‘Corona Harvest’, the document discusses the reaction of Agent Orange and Agent Blue when sprayed in series within the spray tanks clogging up the tanks and spray nozzles. (39) Should this be considered a chemical reaction that possibly could produce other medical disorders that either one exposed to separately could not produce? Many such medical questions have never been resolved. The Vietnam Veteran, in general, is not going to meet the normal genotype population in background exposure levels used in study assessments and baselines. Not only in dioxin isomers but also exposures to other toxic chemicals at the exact same time. A study published in Industrial Health on Dioxin; Exposure-Response Analysis and Risk Assessment made the following statements: (7) Abstract:

…In 1997, dioxin was found to be a human carcinogen by the International Agency for Research on Cancer (IARC), based on four other studies of industrial workers exposed to high levels. Recently there has been interest in estimating human cancer risk at “low-level environmental exposures.” Here we review quantitative exposure – response analysis and risk assessment for low level environmental levels… In the US the background risk of cancer death by 75 is 12%, so doubling the background levels of dioxin exposure risk to somewhere between 12.1 and 13.0%. Our results agree broadly with results from a German cohort, which is the only other cohort for which a quantitative risk assessment has been conducted. (7)

22

22

of 114

This study used 5 part per trillion as a low level assessment.

This study also found that “all cancer sites” were elevated, not just the ones the government/Veterans Affairs has reluctantly stated are associated. Additional statements were made that dioxins may be the first manmade “all site” cancer-producing carcinogen. In addition, those cohort individuals that were exposed to pentachlorophenol (PCP) were excluded from this study. (7)

This study also found that while smoking and asbestos cause cancer at many sites “but not all.” The fact that the Ah receptor occurs in all parts of the body may be the reason for the dioxin, TCDD NOT BEING LIMITED to only a few cancer sites but “all cancer sites.” In addition, SMR for all cancers = 1.46; digestive system cancers = 1.41 (which are still denied by the government/Veteran Affairs); respiratory cancers = 1.67. (7) While not a lot of variance; Vietnam Veterans are still denied at present. Pentachlorophenol is also a major product of the metabolism of hexachlorobenzene in mammals. (8)

…the chronic toxicity observed may depend in large measure on the proportion of chlorodibenzo-p-dioxins present in the mixture. In a 90-day feeding trial in rats, 30 mg/kg/day produced depressed red blood cell and hemoglobin levels as well as liver degeneration, and even lower doses resulted in irregular blood chemistry and enzyme levels, along with increased liver and kidney weights. Pure PCP, and technical PCP without dioxin contamination, produced only slight enlargement of livers and kidneys. Purified PCP failed to produce toxic effects such as liver damage and immune system alterations, which had previously been reported for the technical product. In humans, the most common exposure to PCP is inhalation in the workplace. Abdominal pain, nausea, fever, and respiratory irritation, as well as eye, skin, and throat irritation, may result from such exposure while very high levels may cause obstruction of the circulatory system in the lungs and cause heart failure. Survivors of toxic exposures may suffer permanent visual and central nervous system damage. Persons regularly exposed to PCP tend to tolerate higher levels of PCP vapors than persons having little contact with these vapors.

While cancer is not the subject of the Veterans denial, cancer risk does play a part in the rebuttal of denial. It is clinically impossible to have a cancer causing toxicant that can only produce cancer and not autoimmune derivates of a cancer such as Peripheral Neuropathy. This will be shown in the dysregulation of B and T cells in the immune system found associated and the variances found in the cytokines of the immune system. (See Evidence Section) Many subclinical autoimmune disorders are associated with peripheral neuropathies.

23

23

of 114

The Vietnam Veterans will also demonstrate the association to many such immune disorders that will cause many forms of neuropathy. Including Veterans evidence will show that EPA and NAS now agree – “The NAS committee agreed with EPA's conclusion that dioxins are probably toxic to the human immune system,…” (9) Congresspersons/Senators/Government decision makers must remember that dioxins create at least three immune system damages in Immunotoxicology and combination of damages that the outcomes are multiple in outcomes and severity. Dioxin created:

Immunodeficiency or suppression

Alteration of the host defense mechanism against antigens and carcinogens (one theory is that the immune system detects cells altered by antigens or other carcinogenic triggers and destroys these cells. Thus, an impaired immune system may not detect and destroy a new forming cancer.)

Hypersensitivity or allergy to the chemical antagonist. Because of dioxin’s ability to be both an immunosuppression and a carcinogen, as early as 1978 immunologists were suggesting that "agents such as TCDD.. .may be far more dangerous than those possessing only one of these properties. (10) (11)

Some immunotoxicologists argue that one molecule of a carcinogenic agent, as dioxin in the right place and at the right time, can create a multitude of outcomes and severity in immune system damages. Congresspersons/Senators/Government decision makers must learn from the referenced study. (7) That when graphed as to which fit the parts per trillion in years scenario logarithmic and piece-wise linear graph fits the analysis. This is the important part for those not familiar: a threshold model did not fit the analysis suggesting there was “NO THRESHOLD OF EXPOSURE LEVEL BELOW, WHICH THERE WERE NO CANCER RISKS.” (7) Once again, this study as in the Ranch Hand Study included those exposed by dermal exposures, which is the most benign of all the exposures. Skin does not absorb the toxicants very well. Yet, the lungs and gastrointestinal system readily absorb dioxins. In other words, this study as well as the Ranch Hand Study would be the best-case analysis not the worst-case, including that many disorders found as increased were not brought forward for NAS/IOM review because they did not meet the dioxin linear mandate. This is additional scientific misconduct on the part of our government. No scientific conclusion has been established that in all dioxin associated disorders a linear correlation even exists. Contrary to this Government/Veterans Affairs/NAS-IOM mandate some studies have demonstrated the facts of a non-linear response.

24

24

of 114

The Environmental Protection Agency (EPA) as recently as 2005 stated general exposure levels in its dioxin reassessments, which began in 1992 that while the mid-90’s levels of exposures is about half of what it was in the 1980’s it is still at 25 parts per trillion Toxic Equivalent (TEQ) lipid. (3) The Vietnam Veteran was at his/her most vulnerable for additional cumulative damages in the 1980’s at approximately 55 parts per trillion Toxic Equivalent (TEQ) lipids. Even on long-term damages, there can be no time limit from initial massive multiple toxic chemical exposures resulting from the Veterans wartime service in the parts per trillion range or the parts per million ranges. Chronic exposures resulting in constant/continuous exposures must be considered; not some “initial estimated dose” of one toxic chemical isomer of many toxic chemical isomers involved experienced during only the time spent in Vietnam. Vietnam Veterans are outside this generic qualification of background exposures. As anyone can see it might be the additional 20 or 30 years of dioxin accumulation that is the causation dose or reaches the cumulative body threshold. However, if not for Service in Vietnam in a toxic chemicals environment that elevated his or her increased baseline at an early age, then the mortality and disability manifestations caused by the dioxin, TCDD may not have taken place or had any effect on early mortality or early disability the Veteran now develops. It was known that Peripheral Neuropathies and Chronic Fatigue Syndrome (the old medical term of Neurasthenic Syndrome) were associated to toxic chemical pesticide and herbicide exposures as far back as the late 1940’s. (See Evidence Section) An announcement on 3 December 2006: (12) What are the possible health effects of Dioxin exposures? (12) At high enough levels, dioxins can cause cancer in humans. They can also damage the nervous system and weaken the immune system. Dioxins have caused cardiovascular and respiratory problems, skin disease, birth defects, and other conditions in laboratory animals. In addition, a new medical finding located in dorsal root ganglionitis (inflammation in the spinal cord) - was discovered in a two-week autopsy, with the cause of death listed as Chronic Fatigue Syndrome. This becomes a “clear physical manifestation” of the disorder in the Central Nervous System. This new finding seems to confirm what many scientists have been saying for decades regarding toxic chemical Peripheral Nervous System (PNS) issues and that is before any PNS issues manifest a Central Nervous System (CNS) subclinical event/causation has taken place and precedes any PNS manifestations. While there seems to be a running battle between psychiatrists and medical doctors as to the cause of this disorder, there is a medical physiological issue associated to toxic chemical exposures in our damaged immune systems that create this nerve damage or inflammation as well as the daily debilitating chronic fatigue issues found in 1984 of

25

25

of 114

DEGENERATING NEUROLOGICAL ISSUES by our own government’s studies of those that sprayed the toxic chemicals. (10) (13) The “Government Bias” has always been that toxic chemical etiolgy must be found directly to an antigenic response by the body to the toxicant that caused the peripheral neuropathy. This is a flawed assumption. It is flawed by the assumptions that exposure to multiple toxic chemical events would force the body to a direct response to the dioxin, TCDD, or any other toxicant. With a half-life in the body for a decade or longer thereby demanding the exposures to the various toxic chemicals must be considered as simultaneous or parallel multiple exposures as opposed to a single serial toxicant exposure. This clearly demonstrates that any time limit put on a Veteran for diagnoses is a false conclusion by the government/Veterans Affairs/NAS-IOM in any disorder. Dioxin exposures create many systemic body damages such as in the immune system that will not meet some mandated International Classification of Diseases (ICD). An undefined toxic chemicals syndrome of organ and/or body system systemic (many times subclinical) damages in neurological, endocrine, hematological, immunological, gastrological, cardiovascular, urology, or any combination of each is the result of the exposure. (See Testimony UNDER OATH of Ranch Hand Study Scientist Dr. Richard Albanese in 2000) (14) Each one separately can be the cause of chronic and persistent neuropathies of many types and varieties and even combination of different neuropathies (autonomic, sensory, and motor).

Because of the exposures and combinations of subclinical systemic damages or damages that equate to a syndrome such as a connective tissue disorder many Vietnam Veterans diagnosed with only ischemic peripheral neuropathy become disabled or limited in the time and scope of work they can do demonstrating other medical issues that clearly can be attributed to the exposures. (See Media Three part of this Challenge) {Veteran Affairs scientists Dr. Kang’s recent Veterans Affairs Study report on Agent Orange found significant increases and dioxin associations to diabetes, heart and vascular diseases, all cancers, all respiratory problems (COPD), hypertension, current health is poor - health limits the kind and amount of work that can be done by the Veteran.} The Veterans' Advisory Committee on Environmental Hazards did not qualify the association to “acute or subacute transient peripheral neuropathy” but clearly stated "significant statistical association" between peripheral neuropathy and exposure to dioxin did exist as early as 1991, clearly meeting the requirements in 38 C.F.R. 1.17. While the Committee did put a flawed time limit of 10 years on the manifestation of the nerve damages, it did not indicate any time of resolution of the disorder primarily because the conditions in which the nerve damage is being caused is more than likely not going to be curable such as in autoimmune peripheral neuropathy or even some of the smoldering cancer conditions or undiagnosed toxic

26

26

of 114

chemical caused cancers. This also eliminated the slow progression of the real disorders and long-term development from being compensated or service connected. This particular disorder has an even more obvious government/Veteran Affairs bias and undue hardship on the Vietnam Veteran in that our government put a time limit on not only the manifestation to one year but also the damage to the nerve myelin matter would repair itself within two years after removal from the toxic chemicals or resolve itself. While that may be true for the Department of Defense testing program on Vietnam Veterans in the use of Dapsone for the harsh type of malaria that was found in Vietnam is not true of dioxin associated Peripheral Neuropathies. Dapsone is noted for causing peripheral neuropathy and hematological disorders directly as in a direct antigenic response to the chemicals in Dapsone (a leprosy treatment medication). This is especially true in hematological issues, which is the most common adverse effect and is seen in patients with or without G6PD deficiency. {Glucose 6-phosphate dehydrogenase (G6PD) deficiency is an enzyme deficiency of the red blood cells. G6PD deficiency leads to an abnormal rupture (breakage) of the red blood cells called hemolytic anemia (abnormally low red blood cell count)}. Almost all patients demonstrate the inter-related changes of a loss of 1-2 g of hemoglobin, an increase in the reticulocytes (2-12%), a shortened red cell life span and a rise in methemoglobin with G6PD deficient patients having greater responses. In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, photo toxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus, and an infectious mononucleosis-like syndrome. In general, with the exception of the complications of severe anoxia from over dosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.

Once a medical diagnosis is reached with the patient having these difficulties with red blood cells or Peripheral Neuropathy and muscle weakness, then the recommend medical treatment is to remove the patient from the Dapsone. Normally Recovery on withdrawal is “usually substantially complete.” The mechanism of recovery is reported by axonal regeneration. The previous is an example of how the one year or ten year rule would fit the diagnosed Veterans Affairs/NAS-IOM scenario and even the scenario that in most cases the medical issues caused by the direct taking of the Dapsone (a direct antigenic response) should resolve in most patients once removed. This would also fit the scenario of a poisons such a snakebite, or ingesting a poisonous plant, or even an untreated tick bite. This scenario does not fit the secondary Ah receptor toxic chemical damages done by the dioxin, TCDD, or many toxicants of similar dioxin-like isomer properties to which the Veteran was exposed.

27

27

of 114

Our own Environmental Protection Agency has clearly stated as well as other studies that dioxins in and by themselves do not cause an antigenic body response such as a poisonous plant, spider, snake, or even some types of tick bite. Once again, the taking of Dapsone may produce an antigenic response. In these examples once the body, which varies in time and methodology the body damage is then over, eliminates the toxicant and the body as stated will repair itself "to some level." Common and medical scientific sense mandates that there can be no antigenic response for the dioxins since the dioxins are in the body 40 years after the exposures and can be additive. This would also mandate that since there is no antigenic response there could be no time limit of resolution. This would also mandate that only a Compensation and Pension examination(C & P) for the damages or the doctor’s opinion with diagnostics that the damages being done are getting better or resolving. That is not up to Veterans Affairs or the NAS/IOM for the individual veteran. This would have to conclude that somehow our Government/Veteran Affairs/NAS-IOM has somehow defined the following:

Rate of exposure to manifest this disorder. Minimum body threshold to create this disorder.

Since a time limit is put on the manifestation of the medical issue, the actual causation at root cause failure must have clearly defined medically to the dioxin, TCDD that does not include the cell Ah receptor involvement.

Since a time limit is put on the resolution of the medical issue, the actual

causation at root cause failure levels and the methodology of how removing ones self from the toxic chemical exposures will allow the medical disorder to resolve itself; must be identified and understood and defined by someone or some scientists. (i.e. once removed from the toxicant the damaged myelin nerve matter, axons will regenerate.)

All of the above is based on the nerve damages “not being caused” by a secondary response such as a disturbed immune system in long-term damages in the form of immunotoxicity or neurotoxicity damages, or gastrointestinal issues caused by dioxins, or blood issues caused by dioxins, or any of the other body systems that are damaged by the dioxins, of which any or all of them could cause peripheral nerve damages including a subclinical development of a cancer. They can all or singularly be associated to many types of peripheral neuropathy which is a general term describing many forms of nerve damages.

Therefore, someone, somewhere has determined that direct contact with the dioxin, TCDD at some level will create a level of “direct peripheral nerve damage only.” A

28

28

of 114

further determination is then made that does not involve a central nervous system involvement or any cell DNA or mitochondria cell DNA modifications and they know how it occurs and what the ingestion rate must be and/or the total body threshold is regardless of method of ingestions. Congresspersons/Senators/Government decision makers, Vietnam Veterans find the Veteran Affairs decisions on peripheral neuropathy disorder to be only transient and resolution of disorder BASELESS, PRESUMPTUOUS, AND ERRONEOUS AND NOT SCIENTIFIC AS IT APPLIES TO THE TOXICANTS IN QUESTION.

On July 1, 1991, Secretary of Veterans Affairs Derwinski announced that VA will propose rules granting service-connected disability status to certain veterans with peripheral neuropathy. Proposed rule implementing the Secretary's decision was published for public comment in the Federal Register in January 1992. (See 57 Fed. Reg. 2236, January 21, 1992). It was anticipated that the final rule would be published in 1993. However, in July 1993, when the National Academy of Sciences (NAS) released its comprehensive report, entitled Veterans and Agent Orange - Health Effects of Herbicides Used in Vietnam, peripheral neuropathy was not included in the category "sufficient evidence of an association" or even "limited/suggestive evidence of an association." Rather, the NAS reviewers concluded that there is "inadequate or insufficient evidence to determine whether an association exists between exposure to herbicides (2,4-D; 2,4,5-T and its contaminant TCDD; cacodylic acid; and picloram) and disorders of the peripheral nervous system." The NAS report added, "Although many case reports suggest that an acute or subacute peripheral neuropathy can develop with exposure to TCDD and related chemicals, reports with comparison groups do not offer clear evidence that TCDD exposure is associated with chronic peripheral neuropathy. The most rigorously conducted studies argue against a relationship between TCDD or herbicides and chronic neuropathy." Acute is used to mean immediate effect; as opposed to chronic that means an effect not appearing immediately. VA asked the NAS, in its follow-up report, to consider the relationship between exposure to herbicides and the subsequent development of the acute and subacute effects of peripheral neuropathy (as compared to the chronic effects, which were focused on in the initial report). In January 1994, VA published a notice in the Federal Register that Secretary Brown has determined that a presumption of service connection based on exposure to herbicides used in Vietnam is not warranted for a long list of conditions identified in the NAS report. Peripheral neuropathy was included in this list. (See 59 Fed. Reg. 341, January 4, 1994).

29

29

of 114

What did the NAS 1996 update conclude about peripheral neuropathy? When the NAS reviewers separately reviewed chronic persistent peripheral neuropathy and acute and subacute transient peripheral neuropathy, they found that there was still inadequate or insufficient evidence to determine whether an association exists between exposure to herbicides and chronic persistent peripheral neuropathy. On the other hand, they reported that there is some evidence to suggest, “neuropathy of acute or subacute onset may be associated with herbicide exposure.” They included acute and subacute transient peripheral neuropathy among those conditions they placed in their second category “limited/suggestive evidence of an association.” (Chronic persistent peripheral neuropathy remained in category three, “inadequate/insufficient evidence to determine whether an association exists.”) What was VA’s response to the NAS 1996 finding about acute and subacute transient peripheral neuropathy? After careful review of the report, Secretary Brown decided that VA should add acute and subacute peripheral neuropathy (when manifested within one year of exposure) to the list of conditions recognized for presumption of service connection for Vietnam veterans based on exposure to herbicides. President Clinton announced this, along with other, decisions, at the White House, on May 28, 1996. The proposed rule was published for public comment in the Federal Register in August 1996. (See 61 Fed. Reg. 41368, August 8, 1996). The final rule was published in the Federal Register in November 1996. (See 61 Fed. Reg. 57587, November 7, 1996). What did subsequent NAS updates conclude about peripheral neuropathy? With regard to chronic persistent peripheral neuropathy, the 1998 report stated, “No new information has appeared in the intervening two years that alters this (the 1996) conclusion.” With regard to acute and subacute transient peripheral neuropathy, the 1998 update reported, “The committee is aware of no new publications that bear on this issue. If TCDD were associated with the development of transient acute and subacute peripheral neuropathy, the disorder would become evident shortly after exposure. The committee knows of no evidence that new cases developing long after service in Vietnam are associated with herbicide exposure.” In update 2000: For chronic persistent peripheral neuropathy, there is only inadequate or insufficient evidence to determine whether an association exists between exposure to dioxin or the herbicides studied in this report. NAS found that there was limited/suggestive evidence of an association between exposure to the herbicides considered in this report and acute or subacute transient peripheral neuropathy. The evidence regarding association was drawn from occupation and

30

30

of 114

other studies in which subjects were exposed to a variety of herbicides and herbicide components. Information available to NAS continued to support this conclusion.

The Veterans are, with this submittal, proving the NAS wrong with data from the government’s own studies that prove a peripheral neuropathy association many years after the war was over and nothing has resolved itself and more to the point, it was and is degenerating. Of course, we now know that the government’s own Gold Standard Study was as fraudulent as the chemical company studies were and this was proven in a court of law. These fraudulent chemical company studies were used by Veterans Affairs against the Veterans with White House directed bias. Congresspersons/Senators/Government decision makers, you should remember the statements made above by the Veterans Affairs and NAS/IOM and the statements originally made by the committee that decided our fate from 1979 to 1991 (VACEH) and their findings that there is a "significant statistical association" between “PERIPHERAL NEUROPATHY” and exposure to dioxin shown in the Evidence Section. As you go through the Veterans evidence bear in mind, what other studies have found - even in the government’s exoneration tool the Ranch Hand Study. Veterans think you will agree that in order for NAS/IOM to make the preceding statements that a bias seems to be evident in the scientific world of those that are contracted and controlled by our government.

It would also be imperative to follow these so called NAS “The most rigorously conducted studies argue against a relationship between TCDD or herbicides and chronic neuropathy.” In our Vietnam Veterans case, one must follow the money trail of White House interference as well as political lobby money interference in congress itself.

Ranch Hand studies used as Gold Dioxin Study Standard Flawed.

Media 1 and Media 2 submitted with this challenge document the most rigorously controlled gold standard government study and with one flawed assumption has now rendered 25 years of data and statistics used in Veterans Affairs and NAS/IOM denials of mortality and morbidity issues useless, baseless, and not based on scientific study findings at all. Nothing but flawed assumptions used for 25 years to deny the Vietnam Veteran for government budget control. (See Media 1 and Media 2 at the end of this Challenge.)

These assumptions made by the Ranch Hand Study on the cohort exposures that for all intensive purposes used in government defenses and Veterans denial now lies dead in the water. Especially, since any statistical data is now skewed away from the Veterans position, and in favor of denial. Any low-end findings now could very well be high-end

31

31

of 114

significant findings for Vietnam Veterans and their widows who have said all along in many disorders including Degenerating Peripheral Neuropathy.

The NAS/IOM must be careful in scientific comparisons of exposures of “militarized toxicity formulas” of more dioxins, including the dioxin, TCDD and the six to twenty five times the dose rate to some other form of exposures. We are not talking about Weed-Be-Gone after 1985 with reduced potency and toxicity because of what our returning Vietnam Veterans were developing.

NAS/IOM must also take into consideration that “the contractor” of the NAS/IOM has thwarted, interfered with, tried to stop, and essentially created a “government fraudulent scientific information void.” For example, an early on egregious report at one of our most prestigious research centers, MD Anderson Cancer Center a scientist recanted that the director was interfering with her dioxin research on behalf of friends in the State Department. (More issues in the Government Slippery Slope) Veterans will clearly show the neurological condition, chronic polyneuropathy, is associated to exposures to dioxins as well as the associated Chronic Fatigue Syndrome (formerly diagnosed as Neurasthenic Syndrome) as a stand alone disorder which should be “automatically associated” for all Vietnam Veterans with that diagnosis who served in geographical Vietnam as well as those Veterans that were exposed around the world to the same “government created toxic chemical formulas and doses.” The Chronic Fatigue Issues that go with this nerve disorder also found in exposure victims even in our own government studies that “is just as likely as not” associated to Central Nervous System damage associated with Chronic Fatigue Immune Dysfunction Syndrome, or sometimes called Myalgic Encephalopathy. A recent new finding seems to confirm what many scientists have been saying for decades now regarding Peripheral Nervous System (PNS) issues and that is before any PNS issues manifest a Central Nervous System (CNS) subclinical event/causation has taken place and precedes any PNS manifestations. This seems to be located in dorsal root ganglionitis (inflammation in the spinal cord) - recently discovered in a two-week autopsy, with the cause of death listed as Chronic Fatigue Syndrome. This becomes a “clear physical manifestation” of the neurological disorder. “Evidence reveals that Dow Chemical, a manufacturer of Agent Orange was aware as early as 1964 that TCDD was a byproduct of the manufacturing process. According to Dow’s then medical director, Dr. Benjamin Holder, extreme exposure to dioxins could result in "general organ toxicity" as well as "psychopathological" and "other systemic" problems.” (15)

It should be pointed out here that what Dow considered extreme exposures was a minimum of one part per million (ppm) because the test and evaluation equipment at

32

32

of 114

the time could only measure > 1 ppm. How low the actually exposures were causing "general organ toxicity" as well as *"psychopathological" and "other systemic" problems” are unknown; during this “vague scientific statement.” *{Psychopathological - The manifestation of mental or behavioral disorders. Many toxicologists believe that not only do these toxic chemical herbicides cause peripheral neuropathy (PN) but also CNS issues. This description of our toxic chemical exposures matches no other toxic chemical hazard other than the possibility of the Love Canal, New York environmental disaster, which contained many of the same forms of toxic chemicals to which Vietnam Veterans were exposed. However, once again the dose rate for Vietnam Veterans is much higher than even in the Love Canal disaster. The Times Beach, Missouri dioxin exposures would equal the form of dioxin only exposures but not anywhere close to the levels of dioxin exposures seen by the Vietnam Veterans. Simply put dioxin exposure causes damage to the peripheral and central nervous systems. The association between dioxin and damage to the nervous system is reflected in a finding by the Veterans' Advisory Committee on Environmental Hazards, which recommended that the Veterans Affairs compensate Vietnam Veterans for peripheral neuropathies “as service related.” Many other dioxin studies documented in this challenge also agree. Already discussed in the formal presentation are Veterans Affairs constraints that were put on this “obvious toxic chemical caused disorder” to the point that NO Veteran would qualify. Effects on the central nervous system occur before gross pathological damage can be demonstrated in the peripheral nerves. The neuropsychiatric and neuropsychological symptoms of the central nervous system include depression, anxiety, reduced cognitive function, poor coordination, etc. (13) One severe consequence of central nervous system damage by dioxin is higher rates of suicide (shown in dioxin-exposed Vietnam veterans, chemical production workers, and forestry workers). Another severe consequence is excess deaths from accidents (also significantly elevated in dioxin-exposed chemical production workers and Vietnam Veterans). These accidents could be caused by neurological malfunction, or also represent disguised suicide to a certain extent. (13) Other effects on the central nervous system found in exposed Vietnam veterans and chemical production workers include depression, anxiety, loss of libido, and other neuropsychiatric and neuropsychological effects. Effects on the central nervous system also have been demonstrated in a dose-related manner in Vietnam veterans and chemical production workers, providing firm epidemiological evidence that dioxin caused these effects. (13) In addition, the same range of neuropsychiatric and neuropsychological effects seen in dioxin-exposed populations have been demonstrated for exposure to other neurotoxic substances, such as solvents. This demonstrates a

33

33

of 114

similar biological mechanism between the neuropsychiatric and neuropsychological effects caused by dioxin and other substances. (13)

Peripheral Nerve and Cerebrovascular Abnormalities

Gross abnormalities of the peripheral and central nervous system serve to indicate extreme endpoints of the effects of dioxin. More subtle effects on the central nervous system occur before clinically demonstrable peripheral nerve damage.

PERIPHERAL NERVE AND CEREBROVASCULAR ABNORMALITIES Gold Standard Government Study Ranch Hand

The Air Force Ranch Hand Study in the scientific transcripts stated a found dioxin response to chronic polyneuropathy. (16)

“Data showed a significant increase in the index of polyneuropathy. Another run through the data showed it correlated significantly with dioxin.” (16)

The study summary of findings that appeared statistically significant was presented: (16)

An increase in “inflammatory diseases” was noted, and then debunked by the leader of the study. A significant increase in the index of “polyneuropathy” found was presented when comparing moderate to none on all Ranch Handers. Another run thorough the “polyneuropathy data” correlated significantly with dioxin.

Issues were found with “range of neck motion” and “tendon issues,” especially under repetitive motion exposure.

The scientist citing the inflammatory disease recanted his oral presentation. He was clearer about the “significance of find of associations with inflammatory diseases.”

A significance of finding inflammatory diseases was found. Could that possibly mean and immune system problem?

“A significant and adverse relationship between peripheral neuropathy and dioxin body burden was found.” (17)

One of the leaders of the Ranch Hands studies, Dr. Michalek, in an announcement "Serum dioxin and peripheral neuropathy in veterans of Operation Ranch Hand" stated: "... we consistently found a statistically

34

34

of 114

significant increased risk of all indices of peripheral neuropathy among Ranch Hand veterans…” (18)

Other studies of Vietnam Veterans

The Korean Agent Orange Impact studies in a totally blind honest study with built in quality assurance released in 2003, found dioxin related to peripheral neuropathy at a p-value of 0.039. The study also found a p-value of difference between Vietnam Veterans and non-Vietnam Veterans with peripheral neuropathy of a p-value of difference of 0.0042. An odds ratio (OR) was found of 2.39. (19)

The Korean Agent Orange Impact studies also found cerebrovascular issues as follows:

Brain Atrophy except cerebellum a p-value of 0.0165, Brain Infarction a p-value of 0.0013. In the spinal chord areas, the study found Radiculopathy including herniated intervertebral disc a p-value of <0.0001, Radiculopathy a p-value of 0.0002 was found with an odds ratio (OR) of 3.98, Myelopathy a p-value of 0.0851, and in Spondylosis a p-value of 0.1311 was found. (19)

In a second Korean impact study evaluating the immune system the statement was made: “Based on the results of two epidemiological studies, Peripheral Nerve Disease is the most prevalent disease followed by Lung Cancer, Beurger’s Disease, Larynx Cancer, non-Hodgkin’s Lymphoma, and Chloracne associated with Agent Orange Exposures. Based on the results of two epidemiological studies of probably associated with Agent Orange exposure, Hypertension was the most prevalent disease followed by Diabetes Mellitus, Seborrheic Dermatitis, Central Nervous Diseases, Liver Diseases, Cancer, Hyperlipidemia, Cerbrovascular Disease, Ischemic Heart Disease, and other skin disorders such as Chronic Urticaria and Psoriasis Vulgaris.” (20)

Seveso, Italy

Seveso, Italy Residents in the 15-year mortality/morbidity dioxin only accident study found a “three-fold increase” to five-fold increased depending on age in peripheral neuropathy, obviously at least 15 years after the accident. (21)

If Senators, Congresspersons, Government decision makers, and Congressional Staff Members decide to look at a path to justice for this nations government created disabled veterans then these accounts and facts can certainly be presented as a separate paper. The Veterans will give one more example:

35

35

of 114

In a dioxin-like train spill, 49 Monsanto workers were sent in to clean up the spill. Within 12 years, 45 of the workers had peripheral neuropathy and two workers had committed suicide. It is unknown what happen to the other two. (13) One should ask: How can the VA/NAS-IOM continue to deny such found relationships by the government’s own Gold Standard study and many other similar studies? Simply put - Congress has given the Government entities such as Veterans Affairs and NAS/IOM so much "corrupt power" over Veterans and control over the mandated yearly budget including the questionable use of the Board of Veterans Appeals that denies the Veterans obvious disability based on faulty government statements of fact. “The most severe neuropsychological consequence of dioxin exposure is excessive suicides, which has been demonstrated among exposed Vietnam Veterans, chemical production workers in the U.S. and European countries, forestry workers, and railroad workers. Another severe consequence is the excessive death rate from accidents found among the dioxin-exposed chemical production workers and Vietnam Veterans, representing either motor neuron malfunction or suicide in disguise.

“In 1977, the Working Group of the International Agency for Research on Cancer (IARC) found that neurological and behavioral changes were among the most frequently reported effects in studies of exposures to 2,4,5-T (IARC, 1977a). (13)

IARC identified 6 out of 7 different populations occupationally exposed to

chlorinated phenolic compounds where neuropsychological symptoms such as neurasthenic or depressive syndromes were established (IARC, 1977b). (13)

IARC noted that PNS damage was also found in the same six dioxin-exposed

populations, including polyneuropathies, lower extremity weakness, and sensorial impairments (sight, hearing, smell, taste). (13)

In 1986, the IARC clearly restated it’s finding that dioxin had been found to

be associated with peripheral neuropathies and personality changes (IARC, 1986). (13)

Veterans need not know the etiology of such manifestations and why they are becoming neurological disabled from dioxin exposures only that they are and it is finally recognized. It is time for the Congress to recognize the ruse being perpetrated on Vietnam Veterans and their families by Veterans Affairs and NAS/IOM.

36

36

of 114

Peripheral Neuropathy by the best scientific minds in our nation remains idiopathic in about 33% of the cases. Veterans cannot even get this noted medical diagnostic doubt from our government “so called” friendly government agencies. Peripheral Neuropathic disorders have many causations to include Type II Diabetes Mellitus. Of course, most know of the insulin issues associated with a diabetic involvement and the pain and suffering. It should be noted here that in the only honest testing and evaluation done in the "Veterans Opinion" of Vietnam Veterans and dioxin levels the p-value found on "neuropathy and diabetes" was only remarkable to 0.2157. This is hardly significant in any scientific value. Yet, this same study found both diabetes and peripheral neuropathy independently significant at p <0.5 with respective odds ratios of OR = 2.69 and OR = 2.39. (19) These findings "were significant" after adjusting for potential confounders in:AgeSmokingAlcoholBody mass indexEducationMartial statusHealth insurance How much more do the government caused disabled Veterans of this nation need to prove in order to be compensated in disability for a disorder that has been proven, repeatedly and then re-proven associated with the dioxin exposures? Immune system mediation of Peripheral Neuropathy Immune system mediated, even subclinical immune system mediation can create neuropathic states. The Ranch Hand gold standard study found increases in IgA antibodies as well as increase in Natural Killer cells associated. (13) (13a) (13b) The aforementioned honest second Korean study reported not only found issues in increased IgA but also IgE as well as a disturbances in IgG1 - IgG4 subclass antibody homeostasis (well being) levels. (20) This study also found issues in the quality of blood in number of cells, reduced hemoglobin, and reduced hematocrit. (20) It further found disturbances in cytokines that direct immune system responses creating a confused immune system as to what type of response is required or in some cases rather than one response both are created by the confused immune system. (20)

37

37

of 114

Th1 cells drive the type-1 pathway (“cellular immunity”) to fight viruses and other intracellular pathogens, eliminate cancerous cells, and stimulate delayed-type hypersensitivity (DTH) skin reactions.

Th2 cells drive the type-2 pathway (“humoral immunity”) and up-regulate

antibody production to fight extracellular organisms: type 2 dominance is credited with tolerance of xenografts and of the fetus during pregnancy.

Disturbances found were in: Interlukin 4 and 10Interferon gammaTumor Necrosis Factor alphaThe Interlukin 4 and Interferon gamma ratio was found significantly elevated. The government's own EPA recently stated that it also found cytokine dysregulaton issues with dioxin exposures. (3)

In a recent, paper by Dr. Linda Birnbaum of the EPA they also found cytokine changes associated with dioxin of:

Tumor Necrosis FactorInterlukin 6Interlukin 1 beta

Veterans did not find this Interlukin 1 beta and Interlukin 6 in any studies of Vietnam Veterans but when reviewing our matrix, we did find correlations to the two findings; the EPA’s as well as our own. This certainly can be a simultaneous event since at the cytokine level and below at macrophage and monocyte levels - there is cross communication at real time. Once again, this data is not widely known and doctors look at one or two tests rather than those that can apply to a toxic chemical victim and a compromised immune system. Our Veterans’ doctors do not even know to run an immunoglobulin test on our Nations Government Caused Veteran Victims much less an “Immune Dysregulaton Panel.” The key here for Senators, Congresspersons, Government decision makers, and Congressional Staff Members is the one study found and stated that Military Service in Vietnam and/or Agent Orange Exposures disturbs immune-homeostasis resulting in dysregulation of B and T cell activities. (20)

Disturbance in the immune homeostasis and the dysregulaton of B and T cell activities can certainly be concluded "is as at least as likely as not" the reason for the Veterans Affairs and the NAS/IOM finally but begrudgingly admitting to the few limited cancers we Veterans have as herbicide exposure associated. For the government to conclude, that this found and identified disturbance can only create “a cancer condition” is not only totally biased against the Vietnam Veterans but also would be scientific misconduct on the part of the Veterans Affairs and the

38

38

of 114

NAS/IOM. There are many autoimmune disorders associated to immune system problems to include the found dysregulaton in B and T cell activities in exposures to dioxins.

Since the start of its Dioxin Reassessments in 1992, the EPA has concluded the threshold for dioxin immunotoxicity is much less than that of a dioxin caused cancer. (3) Therefore, it would be statistically, medically, and scientifically impossible to only have a few cancers associated by the government and no autoimmune disorders, standard ICD code or not! Just one of which would be peripheral nerve damages. More on the other issues, Vietnam Veterans have been saying for 40 years now below and how this causation can be the cause of many of our issues of government created death and disability. This issue of immune system dysregulation found that certainly could be considered also associated to the neuropathy damage causation is the cardiovascular issues found significant. Vasculopathy demonstrated a linear suggestion across the four levels of exposures while peripheral vasculopathy did not find this slope. Vasculopathy was found as p-value of difference at 0.0002 while Peripheral Vasculopathy was not significant to dioxin to <0.050 but remarkable to 0.0628. This is certainly well within the realm of tolerances considering the amount of regression analysis. (20) How do these apply to the Vietnam Veterans wide spread Peripheral Neuropathy with or without diabetes and the known and identified damaged immune system? Immune Mediated Autonomic Neuropathies (Roy Freeman, MD) Autonomic nerve fibers are affected in most generalized peripheral neuropathies. While this involvement is often mild or subclinical, there are a group of peripheral neuropathies in which the small or un-myelinated fibers are selectively or prominently targeted. While most generalized peripheral polyneuropathies are accompanied by clinical or subclinical autonomic dysfunction, there are a group of peripheral neuropathies in which the small or un-myelinated fibers are selectively targeted. In these neuropathies, autonomic dysfunction is the primary manifestation. A constellation of signs and symptoms occur from impairment of cardiovascular, gastrointestinal, urogenital, thermoregulatory, sudomotor and pupillomotor autonomic function. (22) The author of this submittal and challenge on behalf of all Veterans, Charles Kelley, has challenged "many times" those in the government hierarchy that with the known prevalence of peripheral neuropathy found associated not only to dioxin exposures but the massive amount found in Vietnam Veterans, especially what is called painful axonal sensory peripheral neuropathy that to conclude Vietnam Veterans diagnosed would

39

39

of 114

have no autonomic nerve damages would be scientific hypocrisy by the Veterans Affairs and the NAS/IOM. This hypocrisy continues to this day. (See Abstract by Dr. Freeman above.)

As you can see from the abstract of Dr. Freedman's article an entire constellation of signs and symptoms occur from impairment of cardiovascular, gastrointestinal, urogenital, thermoregulatory, sudomotor and pupillomotor autonomic function. This becomes even more germane when one looks at the actual findings in dioxin studies supplemented by what was found in Vietnam Veterans in all of our allies that served in the toxic chemical environments. Also included are the gastrointestinal issues (normally diagnosed as IBS), the cardiovascular issues, the breathing rate issues, the COPD issue from minor > sleep apnea, kidney diseases, sexual dysfunction, etc. The latest finding adds more fuel to the fire that is raging among our scientific community in that dioxin exposures directly cause a diabetic condition. The latest study and testing may just conclude that what later studies verified and our Veterans have been correct all along. The peripheral nerve damage (by default autonomic sensory nerve damages must be included) was occurring first and that the dioxin caused immune mediated nerve damage may even be the reason for (in our Vietnam Veterans cases) the increases in insulin sensitivity and “especially insulin resistance.” Therefore, the "scientific purist" may be correct in stating that diabetes is not a direct result of dioxin exposures but rather the secondary effect of the dioxin damaged immune system and the mediated sensory nerve damage created in the endocrine system. Thus, we have he inevitable scientific and logic question of: Which came first - The Chicken or the Egg? To the disabled or dying Vietnam Veteran and his/her family with no support from the government for government created medical issues - it matters not. Tom Blackwell, National PostPublished: Friday, December 15, 2006 In a discovery that has stunned even those behind it, scientists at a Toronto hospital say they have proof the body's nervous system helps trigger diabetes, opening the door to a potential near-cure of the disease that affects millions of Canadians. Diabetic mice became healthy virtually overnight after researchers injected a substance to counteract the effect of malfunctioning pain neurons in the pancreas. "I couldn't believe it," said Dr. Michael Salter, a pain expert at the Hospital for Sick Children and one of the scientists. "Mice with diabetes suddenly didn't have diabetes any more."

40

40

of 114

The researchers caution they have yet to confirm their findings in people, but say they expect results from human studies within a year or so. Any treatment that may emerge to help at least some patients would likely be years away from hitting the market. However, the excitement of the team from Sick Kids, whose work is being published today in The Journal Cell, is almost palpable. "I've never seen anything like it," said Dr. Hans Michael Dosch, an immunologist at the hospital and a leader of the studies. "In my career, this is unique." Their conclusions upset conventional wisdom that Type 1 diabetes, the most serious form of the illness that typically first appears in childhood, was solely caused by autoimmune responses -- the body's immune system turning on itself. They also conclude that there are far more similarities than previously thought between Type 1 and Type 2 diabetes, and that nerves likely play a role in other chronic inflammatory conditions, such as asthma and Crohn's disease. The "paradigm-changing" study opens "a novel, exciting door to address one of the diseases with large societal impact," said Dr. Christian Stohler, a leading U.S. pain specialist and dean of dentistry at the University of Maryland, who has reviewed the work. "The treatment and diagnosis of neuropathic diseases is poised to take a dramatic leap forward because of the impressive research." About two million Canadians suffer from diabetes, 10% of them with Type 1, contributing to 41,000 deaths a year. Insulin replacement therapy is the only treatment of Type 1, and cannot prevent many of the side effects, from heart attacks to kidney failure. In Type 1 diabetes, the pancreas does not produce enough insulin to shift glucose into the cells that need it. In Type 2 diabetes, the insulin that is produced is not used effectively -- something called insulin resistance -- also resulting in poor absorption of glucose. The problems stem partly from inflammation -- and eventual death -- of insulin-producing islet cells in the pancreas. Dr. Dosch had concluded in a 1999 paper that there were surprising similarities between diabetes and multiple sclerosis, a central nervous system disease. His interest was also piqued by the presence around the insulin-producing

41

41

of 114

islets of an "enormous" number of nerves, pain neurons primarily used to signal the brain that tissue has been damaged. Suspecting a link between the nerves and diabetes, he and Dr. Salter used an old experimental trick -- injecting capsaicin, the active ingredient in hot chili peppers, to kill the pancreatic sensory nerves in mice that had an equivalent of Type 1 diabetes. "Then we had the biggest shock of our lives," Dr. Dosch said. Almost immediately, the islets began producing insulin normally "It was a shock? Really out of left field, because nothing in the literature was saying anything about this." It turns out the nerves secrete neuropeptides that are instrumental in the proper functioning of the islets. Further study by the team, which also involved the University of Calgary and the Jackson Laboratory in Maine, found that the nerves in diabetic mice were releasing too little of the neuropeptides, resulting in a "vicious cycle" of stress on the islets. So next, they injected the neuropeptide "substance P" in the pancreases of diabetic mice, a demanding task given the tiny size of the rodent organs. The results were dramatic. The islet inflammation cleared up and the diabetes was gone. Some have remained in that state for as long as four months, with just one injection. They also discovered that their treatments curbed the insulin resistance that is the hallmark of Type 2 diabetes, and that insulin resistance is a major factor in Type 1 diabetes, suggesting the two illnesses are quite similar. {This is of primary importance to the Nations Veterans - insulin resistance that is the hallmark of Type 2 Diabetes; WAS CURBED.} While pain scientists have been receptive to the research, immunologists have voiced skepticism at the idea of the nervous system playing such a major role in the disease. Editors of Cell put the Toronto researchers through vigorous review to prove the validity of their conclusions, though an editorial in the publication gives a positive review of the work. "It will no doubt cause a great deal of consternation," said Dr. Salter about his paper. The researchers are now setting out to confirm that the connection between sensory nerves and diabetes holds true in humans. If it does, they will see if their treatments have the same effects on people as they did on mice. Nothing is for sure, but "there is a great deal of promise," Dr. Salter said.

42

42

of 114

The restated facts above of "surprising similarities between diabetes and multiple sclerosis, a central nervous system disease is very concerning for Vietnam Veterans. Some that started out with a diagnosis of Peripheral Neuropathy end up with a diagnosis of Multiple Sclerosis. This certainly could explain why Vietnam Veterans have Peripheral Neuropathy long before even an impaired glucose tolerance (IGT) is diagnosed.

Veterans are denied Peripheral Neuropathy damages as associated unless they have a defined case of diabetes. Yet, clearly the neuropathy was one of the first disorders found very early on in the Ranch Hand Study and the suspicion later on "long before diabetes was even found associated (which is controversial)" were that subclinical diabetes was the causation. Peripheral Neuropathy is not controversial in any dioxin study of Vietnam Veterans because it correlates p-values of difference as well as association to dioxin exposures. The controversy is with the past and present Secretaries of the Veterans Affairs and the NAS/IOM government controlled bias. Many Vietnam Veterans have this debilitating nerve damage long before they eventually are diagnosed with a Type II diabetic condition or even an Impaired Glucose Tolerance that can take years or even decades to develop. Once again, even with overwhelming statistical and medical evidence of “increased risk of incidence,” “significant correlation to dioxin exposures” in the most benign forms of exposures (skin) our Nation’s disabled Vietnam Veterans are denied Peripheral Nerve damage associations and thereby denied service-connected compensations. There is no compensation for the incredible amount of pain and discomfort that accompanies this medical disorder. Veterans are not even compensated for the medical issues that have and continues to put them at a disadvantage in the work place and at home in a disability created by the UNITED STATES GOVERNMENT. Discussed later will be the additional debilitating issues that accompany this diagnosis of Peripheral Neuropathy in our Vietnam Veterans. More than likely the same issues as described as Kangs report If one considers the recent above findings and testing by the Canadian research team in that damaged pancreatic sensory nerves that control insulin seemed to be associated with both Type I and Type II forms of diabetes. Thus, Department of Defense’s Dr. Michalek’s concern of subclinical diabetes was and is 180 degrees out phase. Instead of peripheral neuropathy with only a possible causation of dioxin created diabetes. The Ranch Hand study did not even concern itself with the possibilty of a dioxin damaged immune system mediated peripheral neuropathy. The concern in the Ranch Hand transcripts and the statement WAS ONLY FOR SUB-CLINICAL DIABETES. Yet, immune system issues were found. No concern was generated toward anything else but possible diabetic involvement causation when during the

43

43

of 114

decades of continuous Peripheral Neuropathy findings no diabetes was found. This was not very logical in a study that was supposed to help decide compensations in morbidity and mortality associated to dioxin, regardless of the etiology. Senators, Congresspersons, Government decision makers, and Congressional Staff Members you will note in the evidence that no one has suggested Peripheral Neuropathy was in any form of being transient. To the contrary, year after year the findings in the same cohorts got worse with or without diabetes. The impacts of the finding by the Canadian Research team may even have wider impacts. Traditional associated issues normally associated with diabetic conditions may even be revisited in medical history. Instead of associated with the diabetic condition causation the wording would have to change now to the disorders associated to a damaged/confused immune system that created a diabetic condition. Most Vietnam Veterans probably will not live long enough since about half of us have died already. However, surviving Vietnam Veterans do hope that our spouses and our children and grandchildren will be around to tell the non-supporting United States Government: OUR FATHERS TOLD YOU SO AND YOU WERE NOT ONLY WRONG, BUT YOU INTENTIONALLY LIED TO THEM, TREATED THEM AS SO MUCH GOVERNMENT CANNON FODDER FOR GOVERNMENT MISTAKES MADE, AND YOU COMMITTED SCIENTIFIC MISCONDUCT FOR THE SAKE OF BUDGETS. Diagnosis and Treatment of Chronic Immune- Mediated Neuropathies Norman Latov, MD, PhD. & Kenneth C. Gorson, MD. & Thomas H. Brannagan, III MD. & Roy L. Freeman, MD & Slobodan Apostolski, MD. & Alan R. Berger, MD. & T Walter G. Bradley, DM, FRCP. & Chiara Briani, MD. & Vera Bril, MD Neil A. Busts, MD. & Didier P. Giros, MD. & Marinos C. Dalakas, MD. & Peter D. Donofrio, MD. & P. James B. Dyck, MD John D. England, MD. & Morris A. Fisher, MD. & David N. Herrmann, MD. & Daniel L. Menkes, MD. & Zarife Sahenk, MD Howard W. Sander, MD. & William J. Triggs, MD. & Jean Michel Vallat, MD. The chronic autoimmune neuropathies are a diverse group of syndromes that result from immune-mediated damage to the peripheral nerves. Our understanding of these disorders has evolved through clinical observations and empiric therapeutic interventions that were confirmed by independent investigators over the years. For many of these disorders, there are no definitive diagnostic tests, and only a few or no controlled therapeutic trials. Consequently, the diagnoses may be missed and the patients remain untreated. The Medical Advisory Board of the Neuropathy Association

44

44

of 114

therefore reviewed the existing literature regarding the diagnosis and treatment of the immune-mediated neuropathies, with the aim of summarizing and presenting the information in a concise form, to help physicians recognize these disorders and decide on the most appropriate therapy. (23) Guillain Barre Syndrome and Its VariantsAlan R. Berger, M.D. Guillain Barre Syndrome most commonly characterized by some combination of limb paresthesias, generalized weakness, and areflexia. Pathogenesis of GBS not yet fully understood and current thinking is that GBS may not be a single disease, but a variety of acute neuropathies with a number of related immune-mediated pathogenetic mechanisms. Most common immunopathologic finding: endoneurial inflammation in spinal nerves roots, distal nerve segments, or around potential nerve entrapment sites. Target antigens appear to be common to the axon, myelin sheath, or both. The exact antigens, the precipitating event, and the resultant mechanism of injury somewhat unclear.

GBS is likely to be multi-factorial, with complex interactions involving humoral and cellular immunity, complement deposition, cytokines and other inflammatory mediators. (24)

This statement by Dr. Berger is as exactly as reported in dioxin studies and the interaction and confusion of dioxin created confusion in humoral and cellular immunotoxicity. This includes the resulting B & T cell dysregulated activity culminating in the Veteran’s malignant cancer, any cancer. CLUES TO THE DIAGNOSIS OF CHRONIC IMMUNE-MEDIATED POLYNEUROPATHIESNorman Latov, M.D., Ph.D.

Autoimmune mechanisms are implicated in several chronic neuropathic syndromes that are amenable to immune therapy (Table I). Collectively, these neuropathies are relatively common; Barohn et al (1998) reported that approximately 13% of consecutive patients with neuropathy seen at their institution had an immune mediated neuropathy, and Verghese et al (2001) found that 6% of their elderly neuropathy patients had a demyelinating inflammatory etiology. However, many of the autoimmune neuropathies are difficult to diagnose, due to a lack of generally accepted clinical diagnostic criteria, or availability of reliable serological tests. Consequently, many patients with autoimmune neuropathies are

45

45

of 114

diagnosed as having "idiopathic neuropathy" instead, and left untreated despite progression of their disease. (25) Vasculitic NeuropathyJose R. Carlo, MD, FAAN The vasculitides are a group of heterogeneous disorders, which present with a variable and complex clinical picture. Debates over clinical versus pathological approaches to classification abound in the literature, all these, with recognized limitations given the variable clinical presentations and the overlap between the recognized diagnostic entities. Peripheral neuropathy is an important, and often the presenting clinical feature of the vasculidities. Its recognition can be critical to attain an early diagnosis in these disorders where the ultimate outcome can be greatly influenced by early therapeutic intervention. (26) Note: The Korean Agent Orange Impact study found Vietnam Veterans had significantly higher frequency of vasculopathy. The p-value of difference was found at 0.0628 with none found in the non-Vietnam category. This included Burger’s Disease, Raynaud’s Syndrome, and other forms of vasculopathy. (19)

“As discussed in later sections, the additional health effects found in this and other Air Force studies on the veterans of Operation Ranch Hand include excess skin cancers and other dermatologic abnormalities, elevated lung cancer rates and lung and thorax abnormalities, excess kidney and bladder cancer, nervous system damage, testicular atrophy and decreased testosterone levels, diabetes, decreased thyroid function, abnormal peripheral vascular functions, immune system abnormalities, and reproductive abnormalities.” (13)

CHRONIC INFLAMMATORY DEMYELINATING NEUROPATHIESThomas H Brannagan III, MD

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a common and under recognized cause of neuropathy. Classically, it is characterized by weakness, large fiber sensory loss, elevated CSF protein, demyelination that may be detected on nerve conduction studies or nerve biopsy, and a response to immuno-modulating treatment. Besides CIDP, there are other acquired demyelinating polyneuropathies, some of which may be considered variants and others that are distinct disorders. This review details the clinical, laboratory; electrophysiological features and treatment options for CIDP and other acquired demyelinating neuropathies. (27)

“As discussed in later sections, the additional health effects found in this and other Air Force studies on the veterans of Operation Ranch Hand include excess skin cancers and

46

46

of 114

other dermatologic abnormalities, elevated lung cancer rates and lung and thorax abnormalities, excess kidney and bladder cancer, nervous system damage, testicular atrophy and decreased testosterone levels, diabetes, decreased thyroid function, abnormal peripheral vascular functions, immune system abnormalities, and reproductive abnormalities.” (13)

In the Ranch Hand transcripts, found associated medical values were consistent with what is considered by the science and medicine as chronic inflammatory conditions (Immune System Issues).

Recently Dr. Michalek (Department of Defense and head of the study for 14 years) and Dr. Ralph Trewyn a two time member of the came forward in the media and clearly STATED THAT RANCH HAND COHORT EXPOSURE ASSUMPTIONS WERE FLAWED. (SEE COMPLETE STORY IN MEDIA 1 AND MEDIA 2) "However, hundreds in the comparison group spent time in Vietnam and may have been exposed to herbicides, too, said Joel Michalek, who worked on the study from the beginning and was its principal investigator for 14 years until he left in May.

“It spoils everything," Michalek told The News. "It's as if you're running a clinical trial on a new medication, and you found out some of the people who were in your placebo group were actually taking meds. That would spoil your whole study. And that's what's going on here in this study”

“They referenced those papers, but they left all the data out from those cancer papers that were done that showed the cancer effects,” he said. “It's huge, because then the conclusion is there's no cancer effect, when as part of the study, the same investigators, just analyzing the data in a different way, found that when they did that, lo and behold, then there were significant cancer effects.

“And so for the final report to say there's no cancer effect when the investigators themselves published papers saying there is a cancer effect, that's just flat scientifically wrong.”

Without factoring in the new information about the comparison veterans, Trewyn said, the Air Force got the same, predictable results.

“When they use an exposed control group and they say the two groups have roughly the same amount of cancer and so forth, what is that finding good for? Nothing,” said Trewyn, vice provost for research and dean of the graduate school at Kansas State

47

47

of 114

University.

Moreover, it doesn't take a scientist to figure that out, he said.

“This is common sense now, a lot of it,” he said. “It's like now wait a minute. This just does not pass the smell test or the common sense test.” Vietnam Veterans would like to point out to recipients of this study that Charles Kelley the author of this document speaking for all Vietnam Veterans, pointed this fact out to those in Washington DC in 2004 with evidence that these cohort assumptions were indeed flawed. Flawed study assumptions that created and had a direct impact on the statistics, dioxin exposure relativity, and how sick and dying Vietnam Veterans actually were in many medical areas, not just cancers. While Dr. Michalek used the example of those in a cohort group that were supposed to be taking placebos and find out after all the statistics and regressions are completed, that they were taking the medication in question then those gathered statistics are invalid. To publish such findings knowing this event took place is misleading and fraudulent. To use comparison data “known to be invalid" in legal matters of denying Vietnam Veterans by not only the initial Veterans Affairs submittal but for BVA use in government decisions to deny that claim, no matter what level it is used, is nothing short of government criminal activity against this nations finest men and women beginning in 1988 and continued to this day.

Charles Kelley, in his example in 2004, used the comparison of a building with two floors that was subjected to toxic fumes or toxic chemicals. By default, the internal areas of the building may have different levels but we do not know exactly what was in the building in total or even in accumulation over time in some areas. Even when part of the toxicity chemicals or fumes is discovered. Science has no idea of the etiology of exposure or the long-term effects of a now what has to be considered as a life catalyst.

The United States Government's idea of justice would be to compare the first floor to the second floor then statistically regress the issues and say, "See we found no medical problem issue differences between the first floor and the second floor." Therefore, it is a non-issue in the building and there were no significant statistical medical disorders found associated to the exposures. The United States Government WOULD NOT COMPARE the cumulative data in the first floor and second floor findings then compare those findings to the identical two stories of a building next door that had no toxic chemicals or toxic fumes. Now we find that even the participating scientists themselves say this flawed White House directed protocol spoils all the statistics. Yet, these tainted and fraudulent findings have been used in legal matters against Vietnam Veterans with purpose and known government directed “fraudulent results.”

48

48

of 114

The scientists concluded with this flawed cohort assumptions that made no sense to Vietnam Veterans to begin with instead of little or no increase found in cancers found would now demonstrate statistically at least a two fold increase IN ALL FORMS OF CANCERS. NOT JUST THOSE CANCERS ON THE BOOKS NOW AS “ASSOCIATED.” Recipients of this study, if we now have an unreported finding in the GOVERNMENTS GOLD STUDY STANDARD of a two fold increase or larger in cancer because of flawed cohort assumptions on exposures. Then any logical person should conclude the findings in other mortality and morbidity issues that have disabled and killed our Vietnam Campaigning Army, even issues that were actually found at some low level, are now minimized. (Discussed in the Government Slippery Slope.)

The Vietnam Veterans have already identified in this report Peripheral Neuropathy found in Ranch Hand studies that correlated to dioxin levels. These were found as significant as pointed out in the studies own transcripts. (16) – (18) and that was using fudged numbers for exposure assumptions admitted to by the study scientists. In fact, we only know significant findings and significant associations were found. If the exposures assumptions were corrected and data recalculated by an honest firm (not associated to the United States Government) then who knows how high the level of association is to dioxin exposures and Peripheral Neuropathy. The typical Vietnam Veteran with diagnosed chronic peripheral neuropathy does not normally have just one symptom that as you have read remains idiopathic for the many reasons stated by Dr. Norman Latov (one of our nations renowned neuropathy experts and also very well known and recognized world wide). The accompanying dioxin issues symptoms not in any particular order of significance includes:

COPD

*Gastrointestinal Issues (normally described and diagnosed as IBS)

Joint pain, weakness, and deterioration with no fever or disfigurement of the joints. Normally testing for RA is not positive but testing for ANA shows positive with an increase in titer but not to the level of ICD Lupus. Is this the chronic progressive degeneration of the stress-bearing portion of a joint called “Neurogenic Arthropathy,” with bizarre hypertrophic changes at the periphery? It is probably a complication of a variety of neurologic disorders, particularly involving loss of sensation, which leads to relaxation of supporting

49

49

of 114

structures and chronic instability of the joint. (Dorland, 27th ed).” For the Vietnam Veteran with peripheral neuropathy and this joint pain, weakness, and deterioration no one seems to either know or really care.

Sexual Dysfunction

Limb Muscle weakness

Subcutanious tissue wasting (feet, lower legs, thighs, hands, arms, etc)

Hematological disorders

**Lipid metabolism issues

Bone pain and Bone density loss

Loss of Balance

***Chronic Fatigue Syndrome

In addition to the above, some Veterans have:

Vascular and heart issues to include valvular issues

Smoldering cancer issues

Cancer issues

* In gastro issues - of major concern is the diagnosis of IBS with the symptoms. Yet, intestinal antibodies associated with lymphoma cancers are not considered in the diagnosis as a toxic chemical exposure Vietnam Veteran victim. A meeting and discussion of developed celiac allergy by Dr. Joseph Murray leading United States expert on the causes and manifestations to the developed symptoms. Example: In the immune mediated gastrointestinal problem the same cells that do the damages in the intestines are the same cells that become lymphoma cancers. The lymphocyte damage in the small intestines not only blocks absorption of critical vitamins and minerals especially such as the B6 and B12 vitamins and A & E vitamins and calcium but also damages the cilia that secrete the enzymes that aide in the digestion of milk and milk products. Lactose then becomes a laxative. B12 is essential for nerve function as well as creation. {Ever wonder why the Vietnam Veterans have bone density loss early in life?}

50

50

of 114

The longer the Veteran this condition the more likely he or she is to develop a lymphoma cancer. Which we know already, at great protest from the government and Veterans Affairs, admitted to as Agent Orange associated. An analogy for this would be the longer a person discontinues smoking the less chance you have of developing lung cancer. The same scenario exits in the damaging lymphocytes in the intestines that remain benign growing and dividing at an accelerated rate and then something triggers one to turn malignant. This form of gastro problem is also more common in Scleroderma and Sjogren's patients because the diseases all come from the same autoimmune tendencies. Inflammatory Bowel Syndrome, which collectively refers to Chron's and Ulcerative Colitis. This autoimmune intestinal condition also causes dermatitis herpetiformis (DH). As the immune system mounts a challenge, it produces antibodies in numbers that often get dumped under the lining of the skin. At that point, they lay in wait for some trigger to set them off, like a land mine. This can be any number of things from sunlight, some cleaners, etc.

{A few Vietnam Veterans have indicated that if do to much physical activity the attack begins.} The itching capabilities of this skin eruption seem to totally diminish any contact and the resulting severity of itching of poison oak or poison ivy. (28) Types of Lymphocytes The three major types of lymphocyte are the natural killer (NK) cells, T cells and B cells. NK cells are a part of cell-mediated immunity and act during the innate immune response. They can attack host cells that display a foreign (e.g. viral) peptide on particular cell surface proteins known as MHC class I molecules. Once they determine a cell is infected, the NK cells release cell-killing (cytotoxic) granules that will destroy the infected cell. NK cells do not require prior activation in order to perform their cytotoxic effect upon target cells. Like NK cells, the T cells are chiefly responsible for cell-mediated immunity whereas B cells are primarily responsible for humoral immunity (relating to antibodies). T cells are named such because these lymphocytes mature in the thymus; B cells (named for the bursa of Fabricius in which they mature in bird species) are thought to mature in the bone marrow in humans. T and B-lymphocytes differ from NK cells in that they are the principal cells involved in the adaptive immune system. These cell types retain a memory of a previous infection so that they can respond to the same infectious agent quickly upon re-infection. In the presence of an antigen, B cells can become much more metabolically active and differentiate into plasma cells, which secrete large quantities of antibodies. T cells, after they see an antigen, will also become highly activated and will secrete specific proteins, such as cytokines and cytotoxic granules, depending on their subtype/function.

51

51

http://en.wikipedia.org/wiki/T_cell

http://en.wikipedia.org/wiki/Granules

http://en.wikipedia.org/wiki/Cytokine

http://en.wikipedia.org/wiki/Antibody

http://en.wikipedia.org/wiki/Plasma_cell

http://en.wikipedia.org/wiki/Metabolism

http://en.wikipedia.org/wiki/Antigen

http://en.wikipedia.org/wiki/Adaptive_immune_system

http://en.wikipedia.org/wiki/Bone_marrow

http://en.wikipedia.org/wiki/Bursa_of_Fabricius

http://en.wikipedia.org/wiki/Thymus

http://en.wikipedia.org/wiki/Antibody

http://en.wikipedia.org/wiki/Humoral_immunity

http://en.wikipedia.org/wiki/Humoral_immunity

http://en.wikipedia.org/wiki/Cell-mediated_immunity

http://en.wikipedia.org/wiki/Cytotoxic

http://en.wikipedia.org/wiki/Major_histocompatibility_complex#MHC_class_I

http://en.wikipedia.org/wiki/Innate_immune_response

http://en.wikipedia.org/wiki/Innate_immune_response

http://en.wikipedia.org/wiki/Cell-mediated_immunity

http://en.wikipedia.org/wiki/B_cells

http://en.wikipedia.org/wiki/B_cells

http://en.wikipedia.org/wiki/T_cells

http://en.wikipedia.org/wiki/NK_cells

of 114

The reason for including the above definitions is germane to the known fact an increase in Natural Killer cells was found although it was dismissed by Ranch Hand. (13b) Whether the new admitted to cohort flaws would change their mind on dismissing the found increase or not probably depends on the direction of “government politics,” not science. We also know by submitted studies that show dioxin exposures are associated to B and T cell dysregulation and immune system controlling cytokines (chemical messengers) dysregulaton and confusion. This IBS gastro condition for the Vietnam Veteran even though the conditions may wax and wane is serious in that the continual gastro problem overtime > barrettes esophagus overtime > esophageal cancer. Note: Many Vietnam Veterans came home with developed gastro problems and intolerances to milk and heavy red meats. This was almost in the context of the 40-year lag time a moment in time one of the first signs of damage. Veterans that had no milk product tolerance before they went either in country or shortly after developed milk intolerance. The waxing and waning of milk intolerance seems to be the clue to another problem in the Vietnam Veteran. ** Many Veterans have lipid metabolism problems, which seemed to begin very early with an increase in triglycerides years before the cholesterol lipid issues even show up in testing. A linear dioxin relationship was found in this triglyceride issue decades ago in the Gold Standard Ranch Hand Study. Including it had been previously found in animal studies even prior to that finding. What is not being considered, thanks to the government's scientific misconduct, is the Highly Sensitive Reactive Protein found in the vascular disorders and very possibly, a dioxin damaged immune system mediated issue yet continually denied. *** Daily debilitating chronic fatigue was found in the Gold Standard Ranch Hand Study as far back as 1984. Yet, once again, this found fact was dismissed and not reported. With the above stated issues in the Vietnam Veterans Evidence Section and the findings specific to immunotoxicity directly caused by the dioxin, TCDD does it not make sense that “yes” while multiple outcomes are present that the damaged immune system seems to be involved in most of the findings? Of course it does. ***The chronic fatigue issue found and then not reported in 1984 may be associated to the old disorder Neurasthenic syndrome. Neurasthenic syndrome - Some medical historians consider neurasthenia to be the diagnostic predecessor of Chronic Fatigue Syndrome. Chronic Fatigue Syndrome (CFS) – Is just what the name implies. A few good days of rest and you still do not recover. No energy, listless, weakness, waking up and felling fatigued, or shortly after

52

52

of 114

doing any work extreme fatigue. May show up in the afternoon with almost feeling like you have flu symptoms with a low-grade fever type of fatigue. At first, some scientists thought this was caused by a nervous disorder therefore the former name neurasthenic syndrome. Then it was found that the Epstein-Barr virus (EBV) was associated. High levels of EBV antibodies (disease-fighting proteins) were found in those patients suffering from CFS. Later diagnosis of CFS of some patients without this high level of disease-fighting proteins indicated there were other causes. Other causes may be iron-poor blood (anemia), low blood sugar (hypoglycemia), environmental allergy, a body wide yeast infection (candidiasis). I have seen some theories that those individuals with neuropathy and that type of condition, that CFS is caused by the damaged nerve endings. Today, CFS also is known as myalgic encephalomyelitis, post viral fatigue syndrome, and chronic fatigue and immune dysfunction syndrome.) Chronic fatigue and immune dysfunction syndrome pointing out this CFS, once again can be attributed to an autoimmune systemic issue caused by toxicant damages the Veterans were and are experiencing. Immune system dysfunction that can lead to both disorders has clearly been found in dioxin studies. Note: The problem for Vietnam Veteran with diabetes involvement is the Veterans Affairs medical codes only reflect this CFS to an autoimmune code and not other associated issues. The Veteran with diabetes and peripheral neuropathy regardless if the associations are in order or not has little chance, of getting the Veterans Affairs to compensate the disorder “as associated” or “as a stand alone disorder” as significant as found in the Ranch Hand Studies as far back as 1984. Yet, clearly this debilitating disorder does exist in significant correlation and increased risk of incidence. Reference Media 3 and Dr. Kang’s report of the following:

VA’S DR. KANG’S RECENT VA REPORT ON AO FOUND SIGNIFICANT INCREASES AND DIOXIN ASSOCIATIONS TO DIABETES, HEART AND VASCULAR DISEASES, ALL CANCERS ALL RESPIRATORY PROBLEMS (COPD), HYPERTENSION, CURRENT HEALTH IS POOR, - HEALTH LIMITS THE KIND AND AMOUNT OF WORK THAT CAN BE DONE BY THE VETERAN

53

53

of 114

THE GOVERNMENT/VETERANS AFFAIRS SLIPPERY SLOPE Congresspersons/Senators/Government decision makers must remember that the Veterans' Advisory Committee on Environmental Hazards (VACEH) clearly stated there was significant statistical evidence that found an association to Peripheral Neuropathy and the dioxin, TCDD in 1991. Congresspersons/Senators/Government decision makers must be aware that in 1989 of our “Vietnam Veterans Toxic Chemical Legacy” showed a district court found after reviewing the legislative history of the 1984 Act "that Congress intended service connection to be granted on the basis of "INCREASED RISK OF INCIDENCE" or a "SIGNIFICANT CORRELATION" between dioxin and various diseases," rather than on the basis of a casual relationship. - See Nehmer v. U.S. Veterans Admin., 712 F. Supp. 1404, 1408. (N.D. Cal. (1989).

Unfortunately, Veterans Affairs never challenged the rulings of the court. Instead, the rulings were ignored and replaced by an order to the Secretary of the Department of Veterans Affairs “to comply” is simply ignored thereby committing clear obstruction of justice. An act known as the Veterans’ Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. 98—542, Oct. 24, 1984 was - considered nothing but a “public relations act” and halfhearted congressional attempt at merely doing something for the nations government damaged Veterans. In recognition of the uncertain state of scientific evidence and the inability to make an absolute causal connection between exposure to herbicides containing dioxin and affliction with various rare cancer diseases, Congress mandated that the Veterans Affairs Administrator resolve any doubt in favor of the veteran seeking compensation. Veterans Affairs not only confounded the perceived intent of Congress, but also directly contradicted its- own established practice of granting compensable service-connection status for diseases on the lesser showing of a statistical association, promulgating instead the more stringent requirement that compensation depends on establishing a "cause and effect relationship."

An example of this non-compliance practice is referenced in BVA Citation Nr: 0317458, Decision Date: 07/24/03 (38) wherein everyone at the BVA agreed the Marines Peripheral Neuropathy was at least with a 50/50 chance the causation of the crippling nerve

54

54

of 114

disorder. The BVA then said that the Marine’s case is denied based on statements made by the NAS/IOM and the Secretary of the Department of Veterans Affairs. We know now and it is proven in this Challenge that the statements made by the NAS/IOM are questionable at best and that the Secretary of the Department of Veterans Affairs certainly exhibited bias on the part of him serving in an appointee position by the White House. The District Court invalidated Veterans Affairs Dioxin regulation, which denied service connection for all diseases other than chloracne; ordered Veterans Affairs to amend its rules; and further ordered that the Advisory Committee (VACEH) reassess all its past recommendations in light of the court’s order. (29) In promulgating such rules, the Dioxin Standards Act required the Veterans Affairs to appoint a Veterans’ Advisory Committee on Environmental Hazards (the "Advisory Committee") -- composed of experts in dioxin, experts in epidemiology, and interested members of the public -- to review the scientific literature on dioxin and submit periodic recommendations and evaluations to the Administrator. (30) Such experts were directed to evaluate the scientific evidence pursuant to regulations promulgated by the Veterans Affairs, and thereafter to submit recommendations and evaluations to the Administrator of the Veterans Affairs on whether "sound scientific or medical evidence" indicated a connection to exposure to Agent Orange and the manifestation of various diseases. (30) Veterans Affairs did not challenge the courts ruling but instead on October 2, 1989, Veterans Affairs amended 38 C.F.R. Part 1, which among other things set forth various factors for the Secretary and the Advisory Committee to consider in determining whether it is "at least as likely as not" that a scientific study shows a "significant statistical association" between a particular exposure to herbicides containing dioxin and a specific adverse health effect. (31)

The Nation’s Vietnam Veterans contend that this stated policy has never been the operating philosophy of Veterans Affairs for Vietnam Veterans. Instead Veterans Affairs has chosen to operate as a government yearly budget control based on the concluding White House Philosophy of the Reagan /Bush White House that clearly defined it did not want the financial responsibility for the toxic chemical nightmare inflicted on our Veterans as well as the environmental disasters in the Republic of Vietnam created by other administrations. This led to a memo put forth by the White House Bureau of Budget to all federal agencies of government in essence not to find a correlation between Agent Orange and health affects. Stating that it would be most unfortunate for two reasons: (32) A) The cost of supporting the Veterans.B) The court liability to which corporations would be exposed.

55

55

of 114

This also would “just as likely as not” conclude the Government was interested in protecting the chemical company industry as well as protecting its own lobby efforts and not supporting government damaged Vietnam Veterans and their families. Clearly, readers of this Challenge should be able to see that in 1991 the actual committee of experts mandated by Congress stated their opinion under the rules mandated by the court and indeed their finding was statistical association. Five years later in 1996 as VA stalled and stalled again the newly Congressional appointed National Academy of Science that conveniently had replaced the VACEH then makes this statement:

“Rather, the NAS reviewers concluded that there is ‘inadequate or insufficient evidence to determine whether an association exists between exposure to herbicides (2,4-D; 2,4,5-T and its contaminant TCDD; cacodylic acid; and picloram) and disorders of the peripheral nervous system’.” During at this exact time frame Ranch Hand was finding specific adverse association to polyneuropathy in its medical transcripts as well as other Nations’ Vietnam Veterans studies were showing peripheral neuropathy as the most prolific disorder associated to the dioxin, TCDD, as documented in the Evidence Section. The NAS conclusions seem biased and spurious at best. When did this occur? It was three decades after the war was over. Therefore, Veterans question the integrity, and the effort put forth by the government contracted NAS/IOM and the possible on purpose omission of findings concluded and clearly stated in Ranch Hand Committee medical transcripts Veterans also question if NAS and VACEH were using the same court mandated level of associations required to associate such disorders. To add insult to injury of our Nations Veterans and pour salt into our open government caused neurological wounds. On May 28, 1996 President William Jefferson Clinton stated in a speech on Veterans Announcements:

REMARKS BY THE PRESIDENTIN VETERANS ANNOUNCEMENT

Room 450Old Executive Office Building

1:22 P.M. EDT May 28, 1996 “THE PRESIDENT: Mr. Vice President, thank you very much, for your very moving remarks and your support of this endeavor. Secretary Brown, thank you for your service to our country in so many ways, and especially for your work at the Veterans Administration, along with Deputy Secretary Hershel Gober and the others who are here. Senator Robb, Congressman Evans, and to members of Congress who are not

56

56

of 114

here, including Senator Daschle who worked so hard on this issue; to the Vietnam veterans who are here and all others who are concerned about this matter: This is an important day for the United States to take further steps to ease the suffering our nation unintentionally caused its own sons and daughters by exposing them to Agent Orange in Vietnam. For over two decades Vietnam veterans made the case that exposure to Agent Orange was injuring and killing them long before they left the field of battle, even damaging their children. For years, the government did not listen. With steps taken since 1993, and the important step we are taking today, we are showing that America can listen and act. I'm announcing that Vietnam veterans with prostate cancer and the neurological disorder, peripheral neuropathy, are entitled to disability payments based upon their exposure to Agent Orange. Our administration will also propose legislation to meet the needs of veterans' children afflicted with the birth defect, spina bifida -- the first time the offspring of American soldiers will receive benefits for combat-related health problems. From the outset, we have pressed hard for answers about the effects of Agent Orange and other chemicals used to kill vegetation during the war in Vietnam. Once we had those answers, we've looked for practical ways to ease the pain of Americans who have already sacrifice so much for their country.” Congresspersons/Senators/Government decision makers this was a nice way to buy votes. It was on the other hand a bunch of Presidential Lies” to our Nations Veterans while congress stood by for the accolades. President Clinton made a big deal out of it and by the time Veterans Affairs finished with its less than truthful constraints not a single Veteran would ever qualify for any service association to what the President described as a “neurological disorder.” Of course, this was all orchestrated. WHY? Because the neurological disorder is associated to immune system damages and those in the White House and Veterans Affairs wanted to stay away from anything that might indicate an association to damaging the immune system even though “it is just as likely as not” that the cancers are being created by a damaged immune system. (See Evidence Section) The United States Government and its federal agencies not only had White House direction but also had and continue to have a budget driven motive for collaboration and collusion. While the Veterans have had three different committees formed that act as judge and executioner during our 40-year legacy. It seems our past congress has been “less than forthcoming” in allowing those Veterans and their families to know exactly “how they are being judged,” to “what level they are being judged,” and what

57

57

of 114

“oversight Congress is providing” to make sure their purported and publicly stated wishes are carried out by the various Presidents and politically appointed Secretary of the Department of Veterans Affairs. Furthermore, any associated government collaborations in reports and studies as well as direct White House interference in such studies and activities directed against our nations Veterans and their families as in House Report HR-101-672 are then dealt with. On March 15 of 2000, the most important government meeting for Vietnam Veterans and their families since conclusion of the war was over was held. This was a “government oversight meeting” to discuss the status of the Air Force’s ongoing “dioxin research only,” called the “Ranch Hand Study.” In reviewing the official transcripts of that oversight meeting of Ranch Hand it was obvious Veterans Affairs, NAS-IOM, and Ranch Hand were NOT GOING TO ANSWER SPECIFIC QUESTIONS by the Congressional membership that bothered to show up. (33)

As with all of our government funded studies, they have been “reduced” or “constrained” to only study the one component of Agent Orange and that being dioxin. Totally disregarding the other two militarized herbicides of Agents White and Blue, much less the other 15 commercial named herbicides that were used. When Ranch Hand scientists actually brought this lack of comprehensive evaluations subject up in the transcripts, the answer was, “That just leaves opportunities for future studies.” Veterans are seeking government help and the medical answers to avoid becoming disabled or taking a dirt nap; the study is looking for “future employment opportunities.” This flawed study totally disregarded evidence from other studies, prevented compensation because illnesses which should be recognized and thereby “service connected” are not recognized. Furthermore, Veterans are often not given adequate medical treatment for these illnesses in the Veterans Affairs health system. This meeting was held as a “government oversight review” of this Air Force study that determines not only our Vietnam Veterans fate but also the fate of many other Veterans by using controlled and manipulated government findings. Not only for compensations but also for medical treatment by our nations doctors and being classified as “Service Connected,” which is also tied to many “state benefits for Disabled Veterans.” Out of 62 members of the “Subcommittee on National Security, Veterans Affairs, and International Relations” and “The Committee of Government Reform,” only “Three Congressmen” bothered showing up to challenge this study, and the DOD, and the VA,

58

58

of 114

and the NAS/IOM; as to why this study and the whole process of determining compensations vehemently wanted no Congressional oversight! When Congressman Christopher Shays asked the NAS representative, Dr. David Butler, Senior Program Officer, Veterans and Agent Orange Reports, Institute of Medicine, National Academy of Sciences also under oath: “Is there any scientific level that we could turn to, short of 99 percent, which would give us some way to come to a conclusion here?” The leader for the IOM that made the recommendations for mortality and morbidity associations and compensations for our Nations Toxic Chemical Exposed Veterans then comes back and said: “The policy decisions are very clearly outside of the mandate for the committees, and the committees have never offered an opinion on the policy decisions, which are made on the basis of that.” Then Congressman Shays asks, “Are you refusing to give your opinion? Dr. Butler then said it is Veterans Affairs job to do that as far as policy as to level of certainty. The VA leader that was there, Dr. Susan Mather, Chief Public Health and Environmental Hazards Officer, Department of Veterans Affairs simply stated Congress had given the “sole power” to the Secretary of the VA and that they had accepted all that the IOM had recommended. The bottom line in this political spin – was ----- no one would say at what level the associations to the toxic chemicals was actually being held and no one pointed out that only the dioxin; TCDD was being considered by Veterans Affairs and Ranch Hand in a plethora of toxic chemicals used on Vietnams Veterans. The above statements are not very comforting to Veterans or their widows, to say the least. One of the Special Study leaders then admitted they were still indeed looking for “cause and effect” and “he thought Congress” had wanted the Veterans to have some other form of “benefit of the doubt” other than “cause and effect” but he was not real clear on what that was and where that fit into the scheme of things as to recommendations for compensations.

59

59

of 114

(Chan, Kwai-Cheung, Director, Special Studies and Evaluations, National Security and International Affairs Division) Mr. Chan stated: “I would like to raise an issue, which I always felt all along, in doing this study and the work that we've done in gulf war illnesses, is that to me there's a fundamental problem between the gathering of the scientific evidence and research in general, versus policymakers in terms of their intent. On one hand in science, we really want to understand if there's a relationship, an association, or correlation. If we find there's a correlation, we then want to make sure that there is a statistically significant relationship. Once we have that, we want to make sure there's a linear dose response. THAT MEANS THE MORE STUFF YOU HAVE THE WORSE YOU GET, IN TERMS OF YOUR PHYSICAL WELL-BEING. MOREOVER, ULTIMATELY, WE WANT TO ESTABLISH CAUSE-AND-EFFECT. Now what we do here, is keep on raising the bar to achieve that end goal and it's a very, VERY IMPORTANT PART OF SCIENCE TO PURSUE IN RESEARCH. Over time the science wants to establish SORT OF A BEYOND A REASONABLE DOUBT, we are doing the right thing. On the other hand, I think, Congress, through various legislation including Public Law 102-4, BASICALLY SUGGESTS THAT WE WANTED TO GIVE THE BENEFIT OF THE DOUBT TO THE VETERANS. THAT IS, IF THEY ARE SICK, BUT WE CAN'T CLEARLY ESTABLISH CAUSE AND----...” Congressman Shays asked: We just do not want to wait until they die before we help them. {Congressman Shays is very wrong. Everything the DoD/VA/NAS-IOM to include White House after White House has done is exactly what Congressman Shays said they did not want to happen.} Mr. Chan stated: - “I understand. But my point is that the science doesn't quite support that approach. Giving them "the benefit of the doubt" means that the risk for the people exposed is higher for than the normal population. Therefore, the risk means that the percentage of people who are exposed sick, versus those who were not exposed but sick of the same illness, is greater than one. Science doesn't work that way. It emphasizes in a statistical significance of I want to make sure that 19 out of 20 times, I'm correct in this decision. So as a result then what happens is that scientific information that”

60

60

of 114

Congressman Shays stated: “I would feel more comfortable though, Mr. Chan, if this scientific research was being done by a party that was not a major player, and I would have a greater comfort level. And I believe that, as a policymaker, I have the right to determine that even there's not a shadow of a doubt, there's every indication that, I'm happy to move forward and commit dollars to helping people. I JUST THINK YOU GIVE THE BENEFIT OF THE DOUBT.” {Congressman Shays is wrong. A "policymaker" when it comes to Veterans Issues has no more power than the Veterans or the Widows of those Veterans to redress any kind of Justice for Executive Branch caused morbidity and mortality.} Dr. Linda Schwartz associate research scientist, Yale University Dr. Schwartz stated: - “If we looked at that as a way in which we could use the data, which has already been collected, then I say yes, the study should be continued. But for us to continue to hang our hat on the fact that this is the "ABSOLUTE GOLD STANDARD" OF WHAT IS HAPPENING TO THE HEALTH OF VETERANS WHO SERVED IN VIETNAM, NO.” Congressman Shays stated: - “DO YOU THINK IT BEING HELD UP AS THE GOLD STANDARD?” Dr. Schwartz stated: “Yes, it is. I think that when the National Academy of Science reviews, even though they do mention in their reports some of the things about Ranch Hand's protocol and study design, that if it's not statistically significant, RANCH HAND DOES NOT PUBLISH IT. THEREFORE, WE ARE NOT GETTING ALL OF THE INFORMATION. If Ranch Hand is publishing, crafting their reports to fit into professional journals, then we are not seeing the things that probably are greater than a 50 percent chance. THEREFORE, WE ARE DENYING VETERANS, OR MAYBE WE ARE DENYING VETERANS SOME COMPENSATION AND DISABILITY FOR THE FACTS THAT WE HAVE NOT REALLY LOOKED AT ALL.” The above statements and discussion are also not very comforting to Veterans or their widows, to say the least and violates the court mandate and the facade of what congress is saying will be compensated for government damages. Does anyone in our government have A STRAIGHT ANSWER ON THIS SUBJECT FOR THE VETERANS DEAD, DYING, AND DISABLED?

61

61

of 114

THE CONCLUSION HAS TO BE NO! The bottom line summary to the above scenario seems to be: The Congressman asks the contracted entity NAS program manager at what level are you looking for significance in determining associations for our Nations Veterans. The contracted entity program manager then says it is not my job but the VA's job to identify the level significance in determining association. Bearing in mind, the NAS and now the NAS/IOM have at least four statements of significance they pronounce every two years. The normal logically person would say how can anyone or any scientific organization identify what “is significant or not significant” to four levels or categories of association. Levels of association that in fact are part of the process by default of the legal claims of dead and dying Veterans. Yet, NAS's Mr. Butler would not or could not even give an example of one of the categories and the equivalent level of association required. Therefore, they are doing something; we are just not sure what or how to measure what it is they are doing. Then the VA's Dr. Susan Mather jumps in trying to get NAS's Mr. Butler off the “Congressional hot seat” of even being committal to anything much other than his name. Dr. Mather then says the VA has accepted all that NAS/IOM had recommended. Again the normal, logically person would conclude how could one say they either do not know or refuse to give the levels of research they are contracted to do. Then the other part of, by default, denying the Veterans legal claim, the VA says: whatever it is, they are doing to whatever level; we have accepted all of it, whatever it is!

Discussed in the "Conclusions Section" - Reviewing the above on what must be considered not only medical associations fraud but also by default legal decisions made against the Veterans Community by the DoD/Veterans Affairs/NAS-IOM/White House in concert without Veterans having any day in court.

More charges of deceit brought forward in the Ranch Hand Study during the oversight review:

Congressman Shays asked: “At what level do you think Government should consider compensation? Should we have a no shadow of a doubt? The reason why I am asking the question is I have concluded, based on our work that we have done on gulf war illnesses, based on our review of Agent Orange, that I have to be honest with our veterans. By the time we will know the scientific data, you are dead. You will either

62

62

of 114

have died early or you will have died in your old age in pain, but you will not get help from the Federal Government.” Congressman Shays stated: “We just do not want to wait until they die before we help them.” Yet, it seems for 40 years that is exactly what our government has been doing!

WAITING FOR THE VIETNAM CAMPAIGNING ARMY TO DIE.

Congressional charges were made that the study was slow to publish findings and that many suggested that the DOD/Veterans Affairs/Ranch Hand collaboration were less than forthcoming in the truth regarding many found toxic chemical medical issues with regard to severity and volume. In one period for over three years, the Ranch Hand did not even meet while Vietnam Veterans died or became disabled with no government help. The excuse was no funding by the Congress was available. One of the scientific advisors to the Veterans Affairs, as well as former and present members of this scientific study made additional charges under oath concerning the flaws of the Ranch Hand Study. The areas of most “serious concern” were:

The use of command influence.

Protocol violations and the changing of established protocols and these were considered quite serious.

The changing of the concluding medical statements after they had been cleared for publication.

Scientists did not consider themselves intellectually free.

Scientific fraud was being committed.

The study was crafting for publication only.

The study was being used as world gold standard, which is incorrect.

If integrity in this study could not be improved then it was suggested that this study as well as any future studies be done by an “independent organization” NOT CONTROLLED BY AN ENTITY OF OUR OWN GOVERNMENT.

63

63

of 114

When discussing birth defects on the paternal side, one of the principal Ranch Hand scientists concluded the published findings of this study were a real tragedy.

A principal Ranch Hand scientist also concluded that for twenty years the Ranch Hand study had not given the Vietnam Veterans a fair assessment of their health status in many different medical areas. These medical areas were in cancers, birth defects, heart disease, vascular disease, neurological ailments, endocrine disturbances, and hematological difficulties.

Cohort selection was questionable. Six years later, we now have more corroboration by two more Ranch Hand scientist including the lead DoD scientist who has come forward - the cohort dioxin exposure assumptions were wrong thereby skewing all statistical analysis in evaluations.

Several scientists and Congressmen indicated that they wanted to see other data that had not been associated with the DVA. (With this submittal, Veterans are giving you this chance!)

After reviewing this Congressional transcript and over 600 pages of Ranch Hand meeting transcripts (not the published reports), as a former components engineer and working in the failure analysis field; I can certainly understand why this study and the DVA processes used to correlate compensations wanted no Congressional oversight. Also found in Congressional Transcripts were: (33)

Charges of this study being done only to exonerate our own government.

Charges of whole chapters being rewritten to de-emphasize the medical findings. (This was particularly directed at immune system damages and immune system dysfunctions.)

Many medical issues found and then not brought forward.

When one scientist suggested he and the others did not want to review the drafts until the Air Force made all their changes from the scientific draft, the leader then stated, we do not want to say, ‘changed.’ The scientists then stated OK, how about ‘air brushed?’ At this point laughter broke out in the meeting room.

64

64

of 114

Senators, Congresspersons, Government decision makers, and Congressional Staff Members I can “assure you that no Vietnam Veteran or Veterans’ widow is laughing at this “despicable study behavior.” We are disabled and dying and this is no laughing matter except it seems to be to those that have perpetrated scientific fraud against the Vietnam Veterans. The most egregious issue I found was the discovery of increased GGT liver enzyme issues and then the suggestion was made that they inform the cohorts to tell their personal doctors of these issues and let them handle it. Never mind the 3.2 million of us that also do exist or at least did exist. {Our numbers are down now to about 1.4 million thanks to the United States Government and its created information void.} A huge misconception about the Ranch Hand Study is the studying of Agent Orange Herbicides. This is in correct. This study had been government reduced to linear dose responses found to the contaminate dioxin (TCDD) only. Even when a dose response is found and no overt disease or disorder is detected “at that moment in medical time,” these findings are discounted and not brought forward into the light of the medical community. What was not taken into consideration is the longer-term systemic damages found in dioxin only. An honest assessment would be - they did find a dose response to certain medical abnormalities, inform the nations’ doctors of such findings, and let the doctors of our nation decide if it is culpable in the Veterans medical manifestations. When no mandated dioxin dose response is found, even if a 50% or more increase is found in one medical issue, it also is not brought forward. This study was not a fair assessment since there were at least four other very toxic chemicals involved.

65

65

of 114

Summary

FOR FORTY YEARS THERE HAS BEEN A GOVERNMENT HISTORY OF DECEIT: Despite Congressional intent to give the Veteran the benefit of the doubt, and in direct opposition to the stated purpose of the Dioxin Standards Act to provide disability compensation to Vietnam Veterans suffering with cancer who were exposed to Agent Orange, Veterans Affairs continues to deny compensation improperly to tens maybe even hundreds of thousands of veterans with just such claims.

Department of Defense scientists Dr. Joel Michalek: “The comparison veterans are similar to average Vietnam Veterans, from nurses to truck drivers, who spent most of their time in base camps. The comparisons' data also should be studied further. The results could matter greatly to thousands of Vietnam War veterans who've never received compensation for debilitating illnesses that earlier Ranch Hand study findings said couldn't be linked to Agent Orange.”

In fact, in promulgating the rules specified by Dioxin Standards Act, the Veterans Affairs not only confounded the intent of the Congress, but also directly contradicted its own established practice of granting compensable service-connection status for diseases on the lesser showing of a statistical association, promulgating instead the more stringent requirement that compensation depends on establishing a “cause and effect relationship.” { See Nehmer v. U.S. Veterans Admin., 712 F. Supp. 1404, 1408. (N.D. Cal. (1989). wherein the court found after reviewing the legislative history of the Act "that Congress intended service connection to be granted on the basis of "increased risk of incidence" or a "significant correlation" between dioxin and various diseases," rather than on the basis of a casual relationship.} The significance of the distinction between a statistical association and a cause and effect relationship is in the burden of proof that the Veteran must satisfy in order to be granted benefits. A statistical association “means that the observed coincidence in

66

66

of 114

variations between exposure to the toxic substance and the adverse health effects is unlikely to be a chance occurrence or happenstance,” whereas the cause and effect relationship “describes a much stronger relationship between exposure to a particular toxic substance and the development of a particular disease than ‘statistically significant association’ does.” Nehmer, 712 F.Supp. at 1416. Thus, the regulation promulgated by Veterans Affairs established an overly burdensome standard by incorporating the causal relationship test within the text of the regulation itself. 38 C.F.R. 1 3.311(d) ("(s] ound scientific and medical evidence does not establish a CAUSE AND EFFECT RELATIONSHIP between dioxin exposure" and any diseases except some cases of chloracne.) As a result, the court invalidated Veterans Affairs Dioxin regulation, which denied service connection for all diseases other than chloracne; ordered the VA to amend its rules; and further ordered that the Advisory Committee reassess its recommendations in light of the court’s order. Thus, on October 2, 1989, the VA amended 38 C.F.R. Part 1, which among other things set forth various factors for the Secretary and the Advisory Committee to consider in determining whether it is “AT LEAST AS LIKELY AS NOT” that a scientific study shows a “significant statistical association” between a particular exposure to herbicides containing dioxin and a specific adverse health effect. 38 C.F.R. Part 1 C.F.R. § 1.17 (d) and determine in his own judgment that the scientific and medical evidence supports the existence of a “significant statistical association” between a particular exposure and a specific disease. 38 C.F.R. § 1.17 (f). (e) For purposes of assessing the relative weights of valid positive and negative studies, other studies affecting epidemiological assessments including case series, correlational studies and studies with insufficient statistical power as well as key mechanistic and animal studies which are found to have particular relevance to an effect on human organ systems may also be considered.

(f) Notwithstanding the provisions of paragraph (d) of this section, a "significant statistical association" may be deemed to exist between a particular exposure and a specific disease if, in the Secretary’s judgment, scientific and medical evidence supports such a decision. As late as the year 2000 in the Congressional Oversight of Ranch Hand review discussed above, anyone can see that the DoD/Veterans Affairs/NAS-IOM/White House is still not doing what Congress intended.

The Veterans’ data submitted within this Challenge certainly concludes in accordance with d., e., and f., above - Peripheral Neuropathy should be approved as a stand-alone disabling disorder associated to toxic chemical

67

67

of 114

exposures of the dioxin, TCDD or other toxic chemicals used in Vietnam by the Government.

A review of the above Ranch Hand discussion that directly defies what

Congress, at least on face value, had indicated they wanted for the Nations Vietnam Veterans in this Toxic Chemical Legacy is hereby submitted.

Mr. Chan, the Director Special Studies and Evaluations, National Security and International Affairs Division, in his discussion clearly indicated that instead of ‘increased risk of incidence’ or a ‘significant correlation’ as the court ruled and the Congress’ intent is or was, a taxpayer paid-for scientific project has been on going to not only identify ‘cause and effect,’ only to the dioxin, TCDD, and that in order of precedence this science project is looking for correlation >statistically significant relationship > linear dose response. (14) Mr. Chan in his discussion is outside the rule of the courts, the congress, and Veterans Affairs regulations themselves as a "significant correlation" or "increased risk of incidence." Veterans are not supposed to need both as the legal description of proof for compensation and service connection is OR not AND! Vietnam Veterans or their Widows in many disorders have met both levels identified in many studies of the dioxin, TCDD. Mr. Chan is way outside the realm of science when he states the ultimate goal of a linear response is the ultimate goal of studies. Dioxins and dioxin like furans the Veterans were exposed to are not antigenic poisons that can be verified by a linear response. Studies have shown, that surprised the study scientists themselves, in exposure levels there is no direct correlation to what dioxins or dioxin-like furans will produce in any individual. There is also no proof that in this non-antigenic toxic chemical that a linear dose response even exists in any one disorder. Nothing has been correlated to the severity of outcomes of ingestions related to severity to any disorder in relationship to body mass or even liver mass. Therefore, this is nothing but "compensations stalling" on the part of the White House Controlled federal government entity, waiting for the campaigning Army to die. EPA has conducted studies that should have killed the animal immediately and yet it did not. Before the animal eventually died it went through "different disorders" to including wasting and eventually death. In direct violation of the Congressional mandate of Benefit of the Doubt as well as Veteran Affairs own regulations, Mr. Chan indicated he and his organization wanted

68

68

of 114

very little doubt. He then suggests that through legislation, Congress had wanted something else but he was not very sure what that something else was in totality. {If the Government's director of Special Studies does not understand the job and the application of that job then he should have asked questions!}

Dr. Linda Schwartz associate research scientist, Yale University... Dr. Schwartz conclusions in a summary of her statements: (14) To continue to use the Ranch Hand study as a Government Gold Standard as it is presently being used is NOT ACCEPTABLE. It is not representative of what is happening to the health of those Veterans who served in Vietnam. The study seems to be crafting for publication. If it is not statistically significant, Ranch Hand does not publish it. Therefore, the NAS and we are not getting all of the information. We are denying veterans, or maybe we are denying veterans some compensation and disability for the facts that we have NOT REALLY LOOKED AT ALL. Additional note: Dr. Schwartz was closer to the real facts of this study than she knew or let on with new admittance of the flaws in Ranch Hand cohort assumption and what Veterans have suggested all along. Not only was the basic premise of the study flawed and way to stringent with White House interference but now, we find that the cohorts selection and assumptions were tragically flawed for many dead and dying Vietnam Veterans. (See Media 1 -3 Releases at end of challenge) Recently the same Dr. Michalek and Dr. Ralph Trewyn (both served on the Ranch Hand Committee) came forward in the media and clearly stated that Ranch Hand assumptions were flawed. “However, hundreds in the comparison group spent time in Vietnam and may have been exposed to herbicides, too, said Joel Michalek, who worked on the study from the beginning and was its principal investigator for 14 years. “It spoils everything," Michalek told The News. "It's as if you're running a clinical trial on a new medication, and you found out some of the people who were in your placebo group were actually taking meds. That would spoil your whole study. And that's what's going on here in this study.” “They referenced those papers, but they left all the data out from those cancer papers that were done that showed the cancer effects, he said. It's huge; because then the conclusion is there's no cancer effect, when as part of the study, the same investigators, just analyzing the data in a different way, found that when they did that, lo and behold, then there were significant cancer effects. “And so for the final report to say there's no cancer effect when the investigators themselves published papers saying there is a cancer effect, that's just flat scientifically wrong.

69

69

of 114

“Without factoring in the new information about the comparison veterans, Trewyn said, the Air Force got the same, predictable results.”

“When they use an exposed control group and they say the two groups have roughly the same amount of cancer and so forth, what is that finding good for? Nothing," said Trewyn, vice provost for research and Dean of the graduate school at Kansas State University. “And it doesn't take a scientist to figure that out, he said. “This is common sense now, a lot of it," he said. "It's like now wait a minute. This just does not pass the smell test or the common sense test." Included in the media release, Dr. Trewyn stated not just specific cancer increases were misreported BUT ALL CANCER SITES. This has been found in other studies that clearly identified there were little differences in specific cancer sites and all cancer sites associated to dioxin exposures, including low-level exposures.

THE GOVERNMENT'S GOLD STANDARD USED AGAINST VIETNAM

VETERANS IS FRAUDULENT! In the above discussion of total fraud our widows and we Vietnam Veterans have found: 1. The government director of studies is outside the scientific evidence level for Peripheral Neuropathy (and other disorders) and seems confused on what it is the Congress wants. He is outside the realm of what science can even do or the definition of the toxic chemical dioxin, TCDD and its in body actions and effects. (14) 2. The gold standard used in compensations and associations of disorders by Veterans Affairs and NAS/IOM is flawed. Data used to deny our initial Veterans Affairs legal claims as well as BVA claims is fraudulent. (14) 3. The NAS program director seems to only want to commit to his name denying he has any idea of what the level of association is required by government contract and not only for the top level of associations but all four levels and their actual levels of associations. He then states that it is Veterans Affairs job of interpretation of association. This agency is under contract to do SOMETHING, yet the program manager cannot tell what that SOMETHING IS or how it is in compliance with what should be "a very specific" Veterans Affairs contract since the NAS clearly indicated it was Veterans Affairs job to determine association requirements “for whatever it is” they are contracted to do.

70

70

of 114

This lack of commitment and knowledge by default are our judge and jury in "Veterans Legal Actions.” The results are used in a legal forum of the individual Veterans Affairs offices as well as the BVA weighted evidence. Particularly since the BVA uses actual statements of findings by the NAS/IOM in denying the Veteran disability or the widow's DIC. Vietnam Veterans and their widows would expect a detailed explanation of how NAS/IOM is meeting whatever the VA requirements are and specific to the levels of association.

This explanation should have all the necessary requirements for an honest assessment. 4. Veterans Affairs states that whatever NAS/IOM has submitted as associated to the four levels or degrees of evidence it has accepted in total. NAS/IOM, then under oath, will not tell the Congress what levels it is looking for and how it arrives/determines the levels by what they are doing under contract and the processes, other than restating the categories of levels by description. Veterans Affairs it has accepted all of what NAS/IOM has done HOWEVER it arrived at the conclusions used against the Vietnam Veteran in the Veterans Affairs court of law. Veterans Affairs has no audit system to make sure the agreement with NAS/IOM’s, own statements should have the levels required in some measurable form and not just NAS/IOM subjectivity since their input of levels determines court rulings as well as decisions made by Secretary of Veterans Affairs. 5. Dr. Schwartz indicates that many of the found issues in the Ranch Hand Study at 50% or larger are not making it in to the reports and/or oral presentations by the Ranch Hand that NAS/IOM uses to determine VA legal actions against the Vietnam Veterans and their Widows. (14) Not all of these facts add up to what the Marquee on the Supreme Court building states as “Justice for All.” What we have is an Executive Branch that manipulates its own legal system empowered by our legislative branch. This totally violates the separation of powers demanded by our constitution.

Our government's response to the statements that the entire Ranch Hand study was used as a GOLD STANDARD for over 25 years at the cost of millions of dollars has been a spoiled study manipulated by multiple presidential administrations and now even the scientists conclude it was fraudulent in its assumptions has been less than forthcoming. This flawed study by default has been used as legal actions against Vietnam Veterans and their widows for decades by Veterans Affairs as well as The Board of Veterans Appeals.

Vietnam Veterans and many in the scientific community have stated since day one this sponsored Ranch Hand study has always been an exoneration tool only and has never

71

71

of 114

been a study for Agent Orange by the use of changing exposure indexes. As Admiral Elmo Zumwalt exclaimed in 1989 Ranch Hand might as well been a study of eating too many beer nuts at the Officers and NCO clubs.

When the controlling Air Force government entity stated they are not going to include the new data in the published reports and then told the scientists to destroy the data, as if none of this ever happened. What has been the response from our elected officials? NOT ONE WORD and NO ACTIONS TAKEN TO STEM THE TIDE OF WHITE HOUSE/VETERANS AFFAIRS MANIPULATION AGAINST VETERANS AND WIDOWS. "The Air Force has no plans to publish the new cancer findings in any Air Force report or scientific journal, Col. Karen Fox told the civilian advisory committee during a meeting in Maryland in response to spirited and sustained questioning during the panel's final meeting. Fox said the Air Force instructed the scientist who conducted the analysis to destroy the data.

Michael Stoto, committee chairmen and a professor at Georgetown University, said the new analysis included "some interesting and potentially important findings" about the health of airmen involved in herbicide spraying missions during the Vietnam War. " What is our elected officials response in the House and Senate and from the President? TOTAL SILENCE! Vietnam Veterans have come to expect the President’s silence over the decades because of protecting White House mistakes and of its uncovered philosophy of "not supporting our Nations' Vietnam Veterans.” Until recently, Vietnam Veterans did not understand the lack of support by those we elected. By all historical accounts created in our form of government to protect those that White House Philosophy has chosen to commit fraudulent activities and a form of tyranny over those constituents. In the civilian world of REAL JUSTICE, this kind of fraudulent activity would have been met with prison time for those that perpetrated the fraudulent medical activity that has continued to allow mortality and morbidity by their own lack of integrity and purpose. Vietnam Veterans also note that the Secretaries of Veterans Affairs have been reluctant to use their legal power defined in C.F.R. § 1.17 (d) to associate these many disorders that other studies have proven not only "increased risk of incidence" but also significant p-values of difference to those exposed and

72

72

of 114

those not exposed in similar cohort military occupational specialties (MOS). Instead, they default to White House directed policy not to compensate for morbidity or mortality that "IS AT LEAST AS LIKELY AS NOT” PROVEN many times over, including this crippling disorder of peripheral nerve damage as a stand-alone disease with its associated disorders.

The following are comments and statements made by Admiral Elmo Zumwalt (now deceased) in 1989 as special pro bono assistant to the Secretary of the Veterans Administration:

Hearings before the Human Resources and Intergovernmental Relations Subcommittee on July 11, 1989 revealed the design, implementation, and conclusions of the CDC study were so ill-conceived as to suggest that political pressures once again interfered with the kind of professional, unbiased review Congress had sought to obtain.

As early as 1986, the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce documented how untutored officials of the Office of Management and Budget (OMB) interfered with and second-guessed the professional judgments of agency scientists and multidisciplinary panels of outside peer review experts effectively to alter or forestall CDC research on the effects of Agent Orange, primarily on the grounds that "enough" dioxin research had already been done. (34)

Dr. Philip Landrigan, the former Director of the Environmental Hazards branch at the CDC, upon discovering the various irregularities in CDC procedures concluded that the errors were so egregious as to warrant an independent investigation not only of the methodology employed by the CDC in its validation study, but also a specific inquiry into what actually transpired at the Center for Environmental Health of the CDC. (35)

These Agent Orange Hearings revealed additional examples of political interference in the CDC's Agent Orange projects by members of the White House Agent Orange Working Group. (36) Political interference in government-sponsored studies associated with Agent Orange has been the norm, not the exception. In fact, there appears to have been a systematic effort to suppress critical data or alter results to meet preconceived notions of what alleged scientific studies were meant to find. (37)

On March 9, 1990 Senator Daschle disclosed compelling evidence of additional political interference in the Air Force Ranch Hand study, a separate government sponsored study meant to examine the correlation between exposure to Agent

73

73

of 114

Orange and harmful health effects among Air Force veterans who participated in Agent Orange spraying. Senator Daschle questioned Air Force scientists on why discrepancies existed between an Air Force draft of the Ranch Hand Study and the final report actually released to the press; the answers suggested not merely disagreements in data evaluation, but the perpetration of fraudulent government conclusions.

CONCLUSIONS

Recipients of this Challenge must recognize that Vietnam Veterans and their widows for over 40 years have been dealt death blow after death blow by our own government in withholding and manipulating medical evidence and findings. Ten’s of thousands or more disabled Veterans have not been supported because of government interference and manipulation of medical findings that have causes their disabilities. The Vietnam Veterans state with the evidence submitted that by all definitions as defined by Veterans Affairs regulations and what Congress intended hereby have been proven:

Peripheral Neuropathies are a direct result of their toxic chemical legacy in their wartime service to this nation by having served in Vietnam. The dioxin, TCDD has been statistically found associated and that the p-values found in those exposed versus those not exposed exceeds the scientific statistical value requirement for automatic associations by the United States Government. (See Evidence Section)

The Government's own Gold Standard that we now know was statistically flawed in bias against the Vietnam Veteran concluded in many transcripts, found associations to Peripheral Neuropathy as far back as 1984. (See Evidence section and also statement by Dr. Michalek "... we consistently found a statistically significant increased risk of all indices of peripheral neuropathy among Ranch Hand veterans. .... )

If Senators, Congresspersons, Government decision makers, and Congressional Staff Members with the above evidence submitted do not find that the crippling disorder of Peripheral Neourpathy is not automatically associated to the exposures in Vietnam as a catalyst for degenerating life long conditions; then the United States Vietnam Veterans

74

74

of 114

and their spouses, widow, and/or orphans demand an accountability as to why the data we have submitted in this challenge and many times before to the Veterans Affairs does not meet the established requirements and the portrayed intent of Congressional requirements regarding this crippling nerve disorder and the other disabling associated medical issues. Other issues that Vietnam Veterans and/or their widows can prove “it is at least as likely as not associated” to wartime service in a toxic chemical environment: Non-Hodgkin’s lymphoma, chloracne and other skin disorders, lip cancer, bone cancer, soft tissue sarcoma, birth defects (physical and mental), skin cancer, porphyria cutanea tarda family of disorders and other liver disorders (such as biliary disorders), Hodgkin’s disease, hematopoietic diseases, multiple myeloma, neurological defects {such as neuropathy (any form}, and cognitive disorders and deficits), autoimmune diseases and disorders (defined and undefined medical codes), leukemia (both CLL and AML), lung cancer and forms of obstructive airway diseases, kidney cancer, malignant melanoma, pancreatic cancer, stomach cancer, colon cancer, nasal/pharyngeal/esophageal cancers, prostate cancer, testicular cancer, liver cancer, brain cancer, neuropsychological effects, gastrointestinal diseases, amyloidosis (primary, secondary, or toxic chemical tertiary), macroglobulinemia (in any form), forms of osteoporoses and/or bone loss, bone tumors and cancer, avascular necrosis, spondylosis, radiculopathy (including herniation of the nucleolus pulposus), brain atrophy, brain infarction, ischemic heart disease, hypertension, vasculopathy, vascular diseases, valvular heart disease, MS, ALS, and Parkinson’s. Many of these disorders in common causation can be found associated to the systemic damages in the body processes instead of what the United States Government/Veteran Affairs/NAS-IOM has done in order to stall and forgo the cumulative multiple disorders. Instead, it takes each individual diagnostics code and tries to ferret out what linear dose caused a specific medical disorder instead of a syndrome or the associated disorder caused by e.g. vasculitis. As in cancers, not everyone is going to develop the same form of cancer or even severity or time for manifestation. For example, vasculitis may produce a variety of ICD codes and not all vasculopathy victims will have the exact same damage. To add insult to the Vietnam Veterans and their Widows insult to morbidity>mortality they have been using government corrupted, and flawed scientific conclusions and statistics. Dr. Trewyn, a 25-year cancer research expert stated regarding the Ranch Hand Study new findings in cancers. "Some people are going to be susceptible to one type of cancer versus another.” Having done research on cancer, it doesn't surprise me at all that you find this at a whole host of different sites."

75

75

of 114

The sum total of this Challenge with the data submitted, the identified interference by the government, the lack of any legitimate identified scientific rational process used in legal denials (judicial branch activity) by the scientists at Veterans Affairs and the NAS/IOM, the pointed out flaws in the Gold Standard used, is: That it is "MORE THAN JUST AS LIKELY AS NOT." The Vietnam Veterans DEBILITATING CHRONIC PERIPHERAL NEUROPATHY AND ASSOCIATED WERE caused by toxic chemical exposures during WARTIME SERVICE TO THIS NATION AND SHOULD BE AN "INCLUSIVE DISORDER" TO WARTIME SERVICE REGARDLESS IF THE VETERAN HAS DIABETES OR NOT! Are the Nation's Veterans now the government's enemy for telling "The Truth" about how we are treated by “elected and appointed” government representatives? As Doctor Ronald Trewyn, wounded Vietnam Veteran of III Corps and Dean of the Graduate School and Vice Provost of Research for Kansas State University, and, a member of the Agent Orange Ranch Hand Advisory Committee stated in the congressional 2000 Government Oversight review: (14)

“…this is more than a Veterans Affairs issue. It is, in fact, a “national security issue.” Because if the country continues to treat their veterans poorly and, in some cases, abominably as has been the case with the veterans suffering from adverse health outcomes from Vietnam, from the Persian Gulf, we're not going to meet the recruitment and retention needs in this new era of needing highly educated, highly technically proficient people. They aren't going to stay in because why should they, when they know what's going to happen going out the other end?”

It is obvious our national media has abandoned Vietnam Veterans dead, dying, and disabled since about year one in the Vietnam War. Whether this lack of support is due, in part to White House Pressure is unknown. There have been some examples of Presidential manipulation found regarding this subject. It is obvious with available data that White House after White House has abandoned an entire ten-year wartime campaigning Army. Sadly with our government caused toxic chemical deaths and wounds it now seems that our own Congress and any form of our Constitutional

76

76

of 114

Judicial System has all but abandoned this government’s created dead and dying assets, its own Veterans.

RECOMMENDATIONS

It is imperative for those Vietnam Veterans that are left alive and those widows and soon to be widows that the both the Senate and House Veterans Affairs Committees look very closely, at what has gone on against the Nations Vietnam Veterans for over four decades now and is still continuing to this day.

In that…The United States Government, The Department of Veterans Affairs, The VACEH, and the NAS/IOM having demonstrated a disturbing bias in their review to date of the scientific literature related to Agent Orange and the Dioxin, TCDD and other toxic chemicals involved either separately or in synergy that is concluded by the Nation’s Vietnam Veterans that -

1. The House and Senate working committees call for the Department for The Veterans Affairs explanation that with this challenge and the scientific, statistical, medical, and study evidence presented can still lead to a denial of such increased risk of incidence and significant correlation demonstrated in the Veterans Challenge.

2. The House and Senate working committees call for the National Academy of Science Institute of Medicine Affairs membership explanation that with this challenge and the scientific, statistical, medical, and study evidence presented can still lead to a denial of such increased risk of incidence and significant correlation demonstrated in the Veterans Challenge.

This Veterans matter requires prompt attention and is of grave emergency by those individuals and Committees listed. No different than congress did on a weekend and holiday and even the President of the United States flew back early from Texas in case legislative-judicial support for the individual Teri Shavo.

It is also put forth that this activity does not require the usual common mode of the Department of Veterans Affairs of “Let’s do another study of such duration” as to

77

77

of 114

allow more and more Veterans to die off at the “Direction of our own White House since when they die their claim dies with them; or suffer the indignities of disability with no support from government caused disability.

These government agencies have to have some level of data that was not purely subjective and they used that data whatever it was against the United States Veteran. It should not take years for those agencies to find the data they used in denial that is scientific, an/or medical, and/or statistical. If they cannot find that data in a few weeks then congress must conclude it was a mockery and charade to begin with; and only subjective to political issues from the White House direction or the Department of the Veterans Affairs singular initiatives to deny the Veterans.

This must be a congressional action alone, as the Veterans of this Nation no longer trust the White House and its political pawn the Department of Veterans Affairs and its’ Executive Branch appointed Secretary.

As a self-educated dioxin “lay expert” with a background in failure analysis and as Dr. Trewyn (two time member of the Ranch Hand Committee) stated, “this is all pretty much common sense now.”

Congress does not have to be the scientific PhD making compensation decisions and compensation laws – just the use of some common sense will suffice.

Charles W. Kelley - and all Vietnam Veterans medically afflicted with Government caused neurological damages DMZ Vietnam 67-68The Toxic Chemical Corridor of QL9Army Commendation Medal2nd Battalion 94th Artillery 175mm SP

78

78

of 114

Those Listed:

President George BushThe White House1600 Pennsylvania Avenue NWWashington, DC 20500 Congressman Bob FilnerChairmanHouse Veterans Affairs CommitteeU.S. House of Representatives2428 Rayburn House Office BuildingWashington, DC 20515 Senator Daniel Akaka Chairmen Senate Veterans Affairs CommitteeSenate Office BuildingWashington D.C. 20510

FOR CONGRESSMAN BUYERCO Mr. Jeff PhillipsCommunications DirectorHouse Veterans Affairs CommitteeU.S. House of Representatives 335 Cannon House Office Building

79

79

of 114

Washington, DC 20515 FOR SENATOR CRAIG CO Mr. Jeff SchadeCommunications DirectorSenate Veterans Affairs Committee412 RussellSenate Office BuildingWashington D.C. 20510

Congressman Christopher ShaysOversight Ranch Hand1126 Longworth BuildingWashington, DC 20515-0704 Mr. Jim NicholsonSecretary - Department of Veterans Affairs810 Vermont Avenue, NW, Room 1000Washington, D.C. 20420 Current Director Compensation & Pension ServiceVA Central Office810 Vermont Avenue, Washington, D.C. 20420 Mr. William McLemoreDeputy Assistant Secretary Intergovernmental and International AffairsDepartment of Veterans Affairs810 Vermont Avenue N.W. Suite 915Washington, DC 20420 Mr. Len SistekU.S. House of Representatives Committee on Veterans AffairsOversight and InvestigationsRoom 333 Cannon House Office BuildingWashington, DC 20515 Mr. Chris McNameeU.S. House of Representatives Committee on Veterans AffairsProfessional Staff Member

80

80

of 114

Subcommittee on Disability Assistance 337 Cannon HOBWashington, DC 20515 Mr. David AbbotStaff Member Compensation & Pension ServiceVA Central Office810 Vermont Avenue, Washington, D.C. 20420 Congressman John Linder1026 Longworth House Office BuildingWashington, DC 20515-1007 Senator Saxby Chambliss416 Russell Senate Office BuildingWashington, DC 20510 Senator Johnny IsacsonSenate Office BuildingWashington, DC 20510 Dr. Michelle Catlin, PhDNational Academy of Sciences500 Fifth Street, NW Washington, DC 20001

Dr. Mary Paxton, PhDSenior Program Officer Population Health and Public Health Practice Institute of Medicine Keck 871, 500 Fifth St., NW Washington, DC 20001

Senator Patty Murray173 Russell Senate Bldg.Washington, D.C. 20510

The Entire House Committee on Veterans' Affairs335 Cannon House Office BuildingWashington, D.C. 20515(202) 225-9756(Congressman Filner please provide copies to all Committee Members)

The Entire Senate Committee on Veterans' Affairs

81

81

of 114

412 RussellSenate Office BuildingWashington D.C. 20510(202) 224-9126 (Senator Akaka please provide copies to all Committee Members)

Senator Jim WebbSenate Russell Building, C1Washington, DC 20510

RAC-Gulf War Veterans' Illnesses (T-GW)Reference: Vietnam Veterans Toxic Chemical LegacyU. S. Department of Veterans Affairs2200 S.W. Gage Blvd.Topeka, KS 66622

House Committee on Oversight and Government ReformSubcommittee on National Security, Veterans Affairs and International Relations,U.S. House of Representatives2157 Rayburn House Office BuildingWashington, D.C. 20515

Attn: Congressman Henry Waxman Chairman (Please distribute this Veterans challenge to your appropriate Committee Membership)

NEWS OUTLETS:

Washington Post

Atlanta Journal and Constitution

New York Times

Knight Ridder News

ABC News

CBS News

NBC News

Cable News Network

Fox News Network

82

82

of 114

REFERENCES (Can be furnished upon request)

(1) EPA Collusion with Industry: A Very Brief Overview, by Liane C. Casten, Environmental Task Force Chair of Chicago Media Watch.

(2) Re-Evaluation of Dioxin A Presentation by Dr. Linda Birnbaum, Director Environmental Toxicology Division U.S. Environmental Protection Agency (EPA) To the 102nd Meeting of the Great Lakes Water Quality Board, Chicago, Illinois

(3) Power-Point Presentation, 2005, Dr. Linda Birnbaum, EPA dioxin expert.

(4) Department of Veterans Affairs Report “Classified Confidential Status 1, not for Publication and Release to the General Public.” A report regarding adverse health affects from exposure to Agent Orange; Dated May 5 1990.

(5) Recognition and Management of Pesticide Poisoning, 5th edition, U.S. EPA, Chapter 14.

(6) The Story of Agent Orange as reported in the U.S. Veteran Dispatch Staff Report November 1990 Issue.

(7) Industrial Health 2003, 41, 175-180 – Dioxin: Exposure-Response Analysis and Risk Assessment. (Low-level exposure analysis)

(8) Extension Toxicology Network Pesticide Information Profiles, Oregon State University, Revised June 1996

83

83

of 114

(9) National Academy of Science Dated July 11, 2006, contact Bill Kearney, Director of Media Relations – [email protected] EPA

(10) Department of Veterans Affairs Report “Classified Confidential Status 1, not for Publication and Release to the General Public.” A report regarding adverse health affects from exposure to Agent Orange; Dated May 5 1990.

(11) Inadvertent Modification of the Immune Response — The Effect of Foods, Drugs, and Environmental Contaminants; Proceedings at the Fourth FDA symposium; U.S. Naval Academy (August 28-30, 1978), p. 78.

(12) SOURCES: National Institute of Environmental Health Sciences, federal Agency for Toxic Substances and Disease Registry

(13) Lawsuit in the United States District Court for the Eastern District of New York, Ivy versus Shamrock Chemicals Company, Affidavit of Cate Jenkins, PH.D. {“The evidence from the 1990 Ranch Hand study (Thomas, et al., 1990) is particularly compelling in demonstrating CNS damage from Agent Orange exposure.

“Significant psychological deficits were found among Ranch Hand veterans in several subscales in a battery of psychological tests. In contrast, none of the typical dioxin-related psychological deficits were ever found in statistical excess among matched controls. Ranch Hand Veterans experienced a statistically significant excess of great or disabling fatigue during the day, a condition found among many other populations exposed to dioxin.)

(13a) (52) August 26-27, 1999 Ranch Hand Advisory Committee Meeting transcripts.

(13b) 1999 OCTOBER RANCH HAND TRANSCRIPTS

(14) March of 2000, House of Representatives, Subcommittee on National Security, Veterans Affairs, and International Relations, Committee on Government Reform, Washington, DC, ;Oversight review of the Ranch Hand Study. (Testimony under oath of Dr. Albanese, Senior Medical Research Officer, U.S. Air Force, former Ranch Hand Principal Investigator; Veterans not getting a fair assessments of systemic body damages, cancers, and birth defects.

(15) See L. Casten, Patterns of Secrecy: Dioxin and Agent Orange (1990) (unpublished manuscript detailing the efforts of government and industry to obscure the serious health consequences of exposure to dioxin).

(16) October 14-15, 1999 Ranch Hand Advisory Committee Meeting, transcripts.

(17) October 19-20, 2000 Ranch Hand Advisory Committee Meeting, transcripts from day one.

84

84

mailto:[email protected]

of 114

(18) Serum dioxin and peripheral neuropathy in veterans of Operation Ranch Hand, 2001 Aug 22 (4): 479-90, Pub Med A Service of The National Library of Medicine and the National Institute of Health.

(19) Impact of Agent Orange Exposure among Korean Vietnam Veterans – Industrial Health 2003, 41, 149-157.

(20) Immunotoxicological Effects of Agent Orange Exposure to the Vietnam War Korean Veterans – Industrial Health 2003, 41, 158-166

(21) Short and Long Term Morbidity and Mortality in the Population Exposed to Dioxin after the Seveso Accident – Industrial Health 2003, 41, 127-138

(22) Immune Mediated Autonomic Neuropathies, Dr. Roy Freeman, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston Massachusetts

(23) Diagnosis and Treatment of Chronic Immune-Mediated Neuropathies, Journal of Clinical Neuromuscular Diseases, Volume 7, Number 3, March 2006

(24) Guillain Barr Syndrome and Its Variants, Dr. Alan R. Berger, Professor and Associate Chairman, Department of Neurology, University of Florida/Jacksonville.

(25) Clues to the Diagnosis of Chronic Immune-Mediated Polyneuropathies, Dr. Norman Latov, Professor of Neurology and Neuroscience, Director Peripheral Neuropathy Center, Weill Medical College of Cornell University.

(26) Vasculitic Neuropathy, Dr. Jose R. Carlo FANN

(27) Chronic Inflammatory Demyelinting Neuropathies, Dr. Thomas H. Brannagan, Cornell University.

(28) A meeting and discussion of developed celiac allergy by Dr. Joseph Murray leading United States expert on the causes and manifestations to the developed symptoms. November 1996.

(29) Nehmer, 712 F. Supp at 1423.

(30) Veterans’ Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. 98—542, Oct. 24, 1984, 98 Stat. 2727 (hereinafter the Dioxin Standards Act) Section 6.

(31) 38 C.F.R. 1.17 (b) & (d). 38 C.F.R. 1.17 - also allows the VA Secretary to override any scientific conclusions on behalf of the VA or the appointee of the Secretary who now has a conflict of interest – The President of the United States.

(32) Taped interview by Moon Callison with Admiral Zumwalt on July 26th 1999 discussing his role in the Department of Veterans Affairs Report “Classified

85

85

of 114

Confidential Status 1, not for Publication and Release to the General Public.” A report regarding adverse health affects from exposure to Agent Orange; Dated May 5 1990. (America’s Defense Monitor (ADM's) Moon Callison interviews the former Chief of Naval Operations, for "Environmental Impact of War").

(33) March of 2000, House of Representatives, Subcommittee on National Security, Veterans Affairs, and International Relations, Committee on Government Reform, Washington, DC, ;Oversight review of the Ranch Hand Study, official transcripts

(34) OMB Review of CDC Research: Impact of the Paperwork Reduction Act; A Report Prepared for the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, 99th Cong. 2nd Sess. (October 1986).

(35) Agent Orange Hearing at 229 and 330

(36) See Agent Orange Hearing at 49-54 (Testimony of Dr. Vernon Houk).

(37) See generally Agent Orange Nearing; Congressional Record, S 2550 (March 9, 1990); Congressional Record, (November 21, 1989) (Statements of Senator Thomas Daschle).

(38) Reference BVA Citation Nr: 0317458, Decision Date: 07/24/03, Archive Date: 07/31/03

(39) Former Top Secret Declassified “Corona Harvest” Defoliation operations in Southeast Asia’ Released in 1970

86

86

of 114

DEFINITION

PERIPHERAL NEUROPATHY

The Essay Author is Julia Barrett.

DEFINITION

The term peripheral neuropathy encompasses a wide range of disorders in which the nerves outside of the brain and spinal cord--peripheral nerves--have been damaged. Peripheral neuropathy may also be referred to as peripheral neuritis, or if many nerves are involved, the terms polyneuropathy or polyneuritis may be used.

DESCRIPTION

Peripheral neuropathy is a widespread disorder, and there are many underlying causes. Some of these causes are common, such as diabetes, and others are extremely rare, such as acrylamide poisoning and certain inherited disorders. The most common worldwide cause of peripheral neuropathy is leprosy. Leprosy is caused by the bacterium Mycobacterium leprae, which attacks the peripheral nerves of affected people. According to statistics gathered by the World Health Organization, an estimated 1.15 million people have leprosy worldwide.

Leprosy is extremely rare in the United States, where diabetes is the most commonly known cause of peripheral neuropathy. It has been estimated that more than 17 million people in the United States and Europe have diabetes-related polyneuropathy. Many neuropathies are idiopathic, meaning that no known cause can be found. The most common of the inherited peripheral neuropathies in the United States is Charcot-Marie-Tooth disease, which affects approximately 125,000 persons.

87

87

of 114

Another of the better-known peripheral neuropathies is Guillain-Barr syndrome, which arises from complications associated with viral illnesses, such as cytomegalovirus, Epstein-Barr virus, and human immunodeficiency virus (HIV), or bacterial infection, including Campylobacter jejuni and Lyme disease. The worldwide incidence rate is approximately 1.7 cases per 100,000 people annually. Other well-known causes of peripheral neuropathies include chronic alcoholism, infection of the varicella-zoster virus, botulism, and poliomyelitis. Peripheral neuropathy may develop as a primary symptom, or it may be due to another disease. For example, peripheral neuropathy is only one symptom of diseases such as amyloid neuropathy, certain cancers, or inherited neurologic disorders. Such diseases may affect the peripheral nervous system (PNS) and the central nervous system (CNS), as well as other body tissues.

To understand peripheral neuropathy and its underlying causes, it may be helpful to review the structures and arrangement of the PNS.

NERVE CELLS AND NERVES

Nerve cells are the basic building block of the nervous system. In the PNS, nerve cells can be threadlike--their width is microscopic, but their length can be measured in feet. The long, spidery extensions of nerve cells are called axons. When a nerve cell is stimulated, by touch or pain, for example, the message is carried along the axon, and neurotransmitters are released within the cell. Neurotransmitters are chemicals within the nervous system that direct nerve cell communication.

Certain nerve cell axons, such as the ones in the PNS, are covered with a substance called myelin. The myelin sheath may be compared to the plastic coating on electrical wires--it is there both to protect the cells and to prevent interference with the signals being transmitted. Protection is also given by Schwann cells, special cells within the nervous system that wrap around both myelinated and un-myelinated axons. The effect is similar to beads threaded on a necklace.

Nerve cell axons leading to the same areas of the body may be bundled together into nerves. Continuing the comparison to electrical wires, nerves may be compared to an electrical cord--the individual components are coated in their own sheaths and then encased together inside a larger protective covering.

PERIPHERAL NERVOUS SYSTEM

The nervous system is classified into two parts: the CNS and the PNS. The CNS is made up of the brain and the spinal cord, and the PNS is composed of the nerves that lead to or branch off from the CNS.

The peripheral nerves handle a diverse array of functions in the body. This diversity is reflected in the major divisions of the PNS--the afferent and the efferent divisions. The afferent division is in charge of sending sensory information from the body to the CNS.

88

88

of 114

When afferent nerve cell endings, called receptors, are stimulated, they release neurotransmitters. These neurotransmitters relay a signal to the brain, which interprets it and reacts by releasing other neurotransmitters.

Some of the neurotransmitters released by the brain are directed at the efferent division of the PNS. The efferent nerves control voluntary movements, such as moving the arms and legs, and involuntary movements, such as making the heart pump blood. The nerves controlling voluntary movements are called motor nerves, and the nerves controlling involuntary actions are referred to as autonomic nerves. The afferent and efferent divisions continually interact with each other. For example, if a person were to touch a hot stove, the receptors in the skin would transmit a message of heat and pain through the sensory nerves to the brain. The message would be processed in the brain and a reaction, such as pulling back the hand, would be transmitted via a motor nerve.

NEUROPATHY NERVE DAMAGE

When an individual has a peripheral neuropathy, nerves of the PNS have been damaged. Nerve damage can arise from a number of causes, such as disease, physical injury, poisoning, or malnutrition. These agents may affect either afferent or efferent nerves. Depending on the cause of damage, the nerve cell axon, its protective myelin sheath, or both may be injured or destroyed.

CLASSIFICATION

There are hundreds of peripheral neuropathies. Reflecting the scope of PNS activity, symptoms may involve sensory, motor, or autonomic functions. To aid in diagnosis and treatment, the symptoms are classified into principal neuropathic syndromes based on the type of affected nerves and how long symptoms have been developing. Acute development refers to symptoms that have appeared within days, and subacute refers to those that have evolved over a number of weeks. Early chronic symptoms are those that take months to a few years to develop, and late chronic symptoms have been present for several years.

The classification system is composed of six principal neuropathic syndromes, which are subdivided into more categories that are specific. By narrowing down the possible diagnoses in this way, specific medical tests can be used more efficiently and effectively. The six syndromes and a few associated causes are listed below:

Acute motor paralysis, accompanied by variable problems with sensory and autonomic functions. Neuropathies associated with this syndrome are mainly accompanied by motor nerve problems, but the sensory and autonomic nerves may also be involved. Associated disorders include Guillain-Barr syndrome, diphtheritic polyneuropathy, and porphyritic neuropathy.

Subacute sensorimotor paralysis. The term sensorimotor refers to neuropathies

that are mainly characterized by sensory symptoms, but also have a minor

89

89

of 114

component of motor nerve problems. Poisoning with heavy metals (e.g., lead, mercury, and arsenic), chemicals, or drugs are linked to this syndrome. Diabetes, Lyme disease, and malnutrition are also possible causes.

Chronic sensorimotor paralysis. Physical symptoms may resemble those in the above syndrome, but the time scale of symptom development is extended. This syndrome encompasses neuropathies arising from cancers, diabetes, leprosy, inherited neurologic and metabolic disorders, and hypothyroidism.

Neuropathy associated with mitochondrial diseases. Mitochondria are

organelles--structures within cells--responsible for handling a cell's energy requirements. If the mitochondria are damaged or destroyed, the cell's energy requirements are not met and it can die.

Recurrent or relapsing polyneuropathy. This syndrome covers neuropathies

that affect several nerves and may come and go, such as Guillain-Barr syndrome, porphyria, and chronic inflammatory demyelinating polyneuropathy.

Mononeuropathy or plexopathy. Nerve damage associated with this syndrome is

limited to a single nerve or a few closely associated nerves. Neuropathies related to physical injury to the nerve, such as carpal tunnel syndrome and sciatica are included in this syndrome.

CAUSES AND SYMPTOMS

Typical symptoms of neuropathy are related to the type of affected nerve. If a sensory nerve is damaged, common symptoms include numbness, tingling in the area, a prickling sensation, or pain. Pain associated with neuropathy can be quite intense and may be described as cutting, stabbing, crushing, or burning. In some cases, a non-painful stimulus may be perceived as excruciating or pain may be felt even in the absence of a stimulus. Damage to a motor nerve is usually indicated by weakness in the affected area. If the problem with the motor nerve has continued over a length of time, muscle shrinkage (atrophy) or lack of muscle tone may be noticeable. Autonomic nerve damage is most noticeable when an individual stands upright and experiences problems such as light-headedness or changes in blood pressure. Other indicators of autonomic nerve damage are lack of sweat, tears, and saliva; constipation; urinary retention; and impotence. In some cases, heart beat irregularities and respiratory problems can develop.

Symptoms may appear over days, weeks, months, or years. Their duration and the ultimate outcome of the neuropathy are linked to the cause of the nerve damage. Potential causes include diseases, physical injuries, poisoning, and malnutrition or alcohol abuse. In some cases, neuropathy is not the primary disorder, but a symptom of an underlying disease.

90

90

of 114

DISEASE

Diseases that cause peripheral neuropathies may either be acquired or inherited; in some cases, it is difficult to make that distinction. The diabetes-peripheral neuropathy link has been well established. A typical pattern of diabetes-associated neuropathic symptoms includes sensory effects that first begin in the feet. The associated pain or pins-and-needles, burning, crawling, or prickling sensations form a typical "stocking" distribution in the feet and lower legs.

Other diabetic neuropathies affect the autonomic nerves and have potentially fatal cardiovascular complications.

Several other metabolic diseases have a strong association with peripheral neuropathy. Uremia, or chronic kidney failure, carries a 10-90% risk of eventually developing neuropathy, and there may be an association between liver failure and peripheral neuropathy. Accumulation of lipids inside blood vessels (atherosclerosis) can choke-off blood supply to certain peripheral nerves. Without oxygen and nutrients, the nerves slowly die. Mild polyneuropathy may develop in persons with low thyroid hormone levels. Individuals with abnormally enlarged skeletal extremities (acromegaly), caused by an overabundance of growth hormone, may also develop mild polyneuropathy.

Neuropathy can also result from severe vasculitides, a group of disorders in which blood vessels are inflamed. When the blood vessels are inflamed or damaged, blood supply to the nerve can be affected, injuring the nerve.

Both viral and bacterial infections have been implicated in peripheral neuropathy. Leprosy is caused by the bacteria M. leprae, which directly attack sensory nerves. Other bacterial illness may set the stage for an immune-mediated attack on the nerves. For example, one theory about Guillain-Barr syndrome involves complications following infection with Campylobacter jejuni, a bacterium commonly associated with food poisoning. This bacterium carries a protein that closely resembles components of myelin. The immune system launches an attack against the bacteria; but, according to the theory, the immune system confuses the myelin with the bacteria in some cases and attacks the myelin sheath as well. The underlying cause of neuropathy associated with Lyme disease is unknown; the bacteria may either promote an immune-mediated attack on the nerve or inflict damage directly.

Infection with certain viruses is associated with extremely painful sensory neuropathies. A primary example of such a neuropathy is caused by shingles. After a case of chickenpox, the causative virus, varicella-zoster virus, becomes inactive in sensory nerves. Years later, the virus may be reactivated. Once reactivated, it attacks and destroys axons. Infection with HIV is also associated with peripheral neuropathy, but the type of neuropathy that develops can vary. Some HIV-linked neuropathies are noted for myelin destruction rather than axonal degradation. In addition, HIV infection is frequently accompanied by other infections, both bacterial and viral, that are associated with neuropathy.

91

91

of 114

Several types of peripheral neuropathies are associated with inherited disorders. These inherited disorders may primarily involve the nervous system, or the effects on the nervous system may be secondary to an inherited metabolic disorder. Inherited neuropathies can fall into several of the principal syndromes, because symptoms may be sensory, motor, or autonomic. The inheritance patterns also vary, depending on the specific disorder. The development of inherited disorders is typically drawn out over several years and may herald a degenerative condition--that is, a condition that becomes progressively worse over time. Even among specific disorders, there may be a degree of variability in inheritance patterns and symptoms. For example, Charcot-Marie-Tooth disease is usually inherited as an autosomal dominant disorder, but it can be autosomal recessive or, in rare cases, linked to the X chromosome. Its estimated frequency is approximately one in 2,500 people. Age of onset and sensory nerve involvement can vary between cases. The main symptom is a degeneration of the motor nerves in legs and arms, and resultant muscle atrophy. Other inherited neuropathies have a distinctly metabolic component. For example, in familial amyloid polyneuropathies, protein components that make up the myelin are constructed and deposited incorrectly.

PHYSICAL INJURY

Accidental falls and mishaps during sports and recreational activities are common causes of physical injuries that can result in peripheral neuropathy. The common types of injuries in these situations occur from placing too much pressure on the nerve, exceeding the nerve's capacity to stretch, blocking adequate blood supply of oxygen and nutrients to the nerve, and tearing the nerve. Pain may not always be immediately noticeable, and obvious signs of damage may take a while to develop.These injuries usually affect one nerve or a group of closely associated nerves. For example, a common injury encountered in contact sports such as football is the "burner," or "stinger," syndrome. Typically, a stinger is caused by overstretching the main nerves that span from the neck into the arm. Immediate symptoms are numbness, tingling, and pain that travels down the arm, lasting only a minute or two. A single incident of a stinger is not dangerous, but recurrences can eventually cause permanent motor and sensory loss.

POISONING

The poisons, or toxins, that cause peripheral neuropathy include drugs, industrial chemicals, and environmental toxins. Neuropathy that is caused by drugs usually involves sensory nerves on both sides of the body, particularly in the hands and feet, and pain is a common symptom. Neuropathy is an unusual side effect of medications; therefore, most people can use these drugs safely. A few of the drugs that have been linked with peripheral neuropathy include metronidazole, an antibiotic; phenytoin, an anticonvulsant; and simvastatin, a cholesterol-lowering medication.

92

92

of 114

Certain industrial chemicals have been shown to be poisonous to nerves (neurotoxic) following work-related exposures. Chemicals such as acrylamide, allyl chloride, and carbon disulfide have all been strongly linked to development of peripheral neuropathy. Organic compounds, such as N-hexane and toluene, are also encountered in work-related settings, as well as in glue-sniffing and solvent abuse. Either route of exposure can produce severe sensorimotor neuropathy that develops rapidly.

Heavy metals are the third group of toxins that cause peripheral neuropathy. Lead, arsenic, thallium, and mercury usually are not toxic in their elemental form, but rather as components in organic or inorganic compounds. The types of metal-induced neuropathies vary widely. Arsenic poisoning may mimic Guillain-Barr syndrome; lead affects motor nerves more than sensory nerves; thallium produces painful sensorimotor neuropathy; and the effects of mercury are seen in both the CNS and PNS.

MALNUTRITION AND ALCOHOL ABUSE

Burning, stabbing pains and numbness in the feet, and sometimes in the hands, are distinguishing features of alcoholic neuropathy. The level of alcohol consumption associated with this variety of peripheral neuropathy has been estimated as approximately 3 L of beer or 300 mL of liquor daily for three years. However, it is unclear whether alcohol alone is responsible for the neuropathic symptoms, because chronic alcoholism is strongly associated with malnutrition.

Malnutrition refers to an extreme lack of nutrients in the diet. It is unknown precisely which nutrient deficiencies cause peripheral neuropathies in alcoholics and famine and starvation patients, but it is suspected that the B vitamins have a significant role. For example, thiamine (vitamin B1) deficiency is the cause of beriberi, a neuropathic disease characterized by heart failure and painful polyneuropathy of sensory nerves. Vitamin E deficiency seems to have a role in both CNS and PNS neuropathy.

DIAGNOSIS

Clinical symptoms can indicate peripheral neuropathy, but an exact diagnosis requires a combination of medical history, medical tests, and possibly a process of exclusion. Certain symptoms can suggest a diagnosis, but more information is commonly needed. For example, painful, burning feet may be a symptom of alcohol abuse, diabetes, HIV infection, or an underlying malignant tumor, among other causes. Without further details, effective treatment would be difficult.

During a physical examination, an individual is asked to describe the symptoms very carefully. Detailed information about the location, nature, and duration of symptoms can help exclude some causes or even pinpoint the actual problem. The person's medical history may also provide clues as to the cause, because certain diseases and medications are linked to specific peripheral neuropathies. A medical history should also include information about diseases that run in the family, because some peripheral

93

93

of 114

neuropathies are genetically linked. Information about hobbies, recreational activities, alcohol consumption, and work place activities can uncover possible injuries or exposures to poisonous substances.

The physical examination also includes blood tests, such as those that check levels of glucose and creatinine to detect diabetes and kidney problems, respectively. A blood count is also done to determine levels of different blood cell types. Iron, vitamin B12, and other factors may be measured as well, to rule out malnutrition.

More specific tests, such as an assay for heavy metals or poisonous substances, or tests to detect vasculitis, are not typically done unless there is reason to suspect a particular cause.

An individual with neuropathy may be sent to a doctor that specializes in nervous system disorders (neurologist). By considering the results of the physical examination and observations of the referring doctor, the neurologist may be able to narrow down the possible diagnoses. Additional tests, such as nerve conduction studies and electromyography, which tests muscle reactions, can confirm that nerve damage has occurred and may be able to indicate the nature of the damage. For example, some neuropathies are characterized by destruction of the myelin. This type of damage is shown by slowed nerve conduction. If the axon itself has suffered damage, the nerve conduction may be slowed, but it will also be diminished in strength. Electromyography adds further information by measuring nerve conduction and muscle response, which determines whether the symptoms are due to a neuropathy or to a muscle disorder.

In approximately 10% of peripheral neuropathy cases, a nerve biopsy may be helpful. In this test, a small part of the nerve is surgically removed and examined under a microscope. This procedure is usually the most helpful in confirming a suspected diagnosis, rather than as a diagnostic procedure by itself.

TREATMENT

Treat the cause

Attacking the underlying cause of the neuropathy can prevent further nerve damage and may allow for a better recovery. For example, in cases of bacterial infection such as leprosy or Lyme disease, antibiotics may be given to destroy the infectious bacteria. Viral infections are more difficult to treat, because antibiotics are not effective against them. Neuropathies associated with drugs, chemicals, and toxins are treated in part by stopping exposure to the damaging agent. Chemicals such as ethylenediaminetetraacetic acid (EDTA) are used to help the body concentrate and excrete some toxins. Diabetic neuropathies may be treated by gaining better control of blood sugar levels, but chronic kidney failure may require dialysis or even kidney transplant to prevent or reduce nerve damage. In some cases, such as compression injury or tumors, surgery may be considered to relieve pressure on a nerve.

94

94

of 114

In a crisis situation, as in the onset of Guillain-Barr syndrome, plasma exchange, intravenous immunoglobulin, and steroids may be given. Intubation, in which a tube is inserted into the trachea to maintain an open airway, and ventilation, may be required to support the respiratory system. Treatment may focus more on symptom management than on combating the underlying cause, at least until a definitive diagnosis has been made.

SUPPORTIVE CARE AND LONG-TERM THERAPY

Some peripheral neuropathies cannot be resolved or require time for resolution. In these cases, long-term monitoring and supportive care is necessary. Medical tests may be repeated to chart the progress of the neuropathy. If autonomic nerve involvement is a concern, regular monitoring of the cardiovascular system may be carried out.

Because pain is associated with many of the neuropathies, a pain management plan may need to be mapped out, especially if the pain becomes chronic. As in any chronic disease, narcotics are best avoided. Agents that may be helpful in neuropathic pain include amitriptyline, carbamazepine, and capsaicin cream.

Physical therapy and physician-directed exercises can help maintain or improve function. In cases in which motor nerves are affected, braces and other supportive equipment can aid an individual's ability to move about.

PROGNOSIS

The outcome for peripheral neuropathy depends heavily on the cause. Peripheral neuropathy ranges from a reversible problem to a potentially fatal complication. In the best cases, a damaged nerve regenerates. Nerve cells cannot be replaced if they are killed, but they are capable of recovering from damage. The extent of recovery is tied to the extent of the damage and a person's age and general health status. Recovery can take weeks to years, because neurons grow very slowly. Full recovery may not be possible and it may also not be possible to determine the prognosis at the outset.

If the neuropathy is a degenerative condition, such as Charcot-Marie-Tooth disease, an individual's condition will become worse. There may be periods of time when the disease seems to reach a plateau, but cures have not yet been discovered for many of these degenerative diseases. Therefore, continued symptoms, potentially worsening to disabilities are to be expected.

A few peripheral neuropathies are eventually fatal. Fatalities have been associated with some cases of diphtheria, botulism, and others. Some diseases associated with neuropathy may also be fatal, but the ultimate cause of death is not necessarily related to the neuropathy, such as with cancer.

PREVENTION

95

95

of 114

Peripheral neuropathies are preventable only to the extent that the underlying causes are preventable. Steps that a person can take to prevent potential problems include vaccines against diseases that cause neuropathy, such as polio and diphtheria. Treatment for physical injuries in a timely manner can help prevent permanent or worsening damage to nerves. Precautions when using certain chemicals and drugs are well advised in order to prevent exposure to neurotoxic agents. Control of chronic diseases such as diabetes may also reduce the chances of developing peripheral neuropathy.

Although not a preventive measure, genetic screening can serve as an early warning for potential problems. Genetic screening is available for some inherited conditions, but not all. In some cases, presence of a particular gene may not mean that a person will necessarily develop the disease, because there may be environmental and other components involved.

KEY TERMS

Afferent

Refers to peripheral nerves that transmit signals to the spinal cord and the brain. These nerves carry out sensory function.

Autonomic

Refers to peripheral nerves that carry signals from the brain and that control involuntary actions in the body, such as the beating of the heart.

Autosomal dominant or autosomal recessive

Refers to the inheritance pattern of a gene on a chromosome other than X or Y. Genes are inherited in pairs--one gene from each parent. However, the inheritance may not be equal, and one gene may overshadow the other in determining the final form of the encoded characteristic. The gene that overshadows the other is called the dominant gene; the overshadowed gene is the recessive one.

Axon

A long, threadlike projection that is part of a nerve cell.

Central nervous system (CNS)

The part of the nervous system that includes the brain and the spinal cord.

96

96

of 114

Efferent

Refers to peripheral nerves that carry signals away from the brain and spinal cord. These nerves carry out motor and autonomic functions.

Electromyography

A medical test that assesses nerve signals and muscle reactions. It can determine if there is a disorder with the nerve or if the muscle is not capable of responding.

Inheritance pattern

Refers to dominant or recessive inheritance.

Motor

Refers to peripheral nerves that control voluntary movements, such as moving the arms and legs.

Myelin

The protective coating on axons.

Nerve biopsy

A medical test in which a small portion of a damaged nerve is surgically removed and examined under a microscope.

Nerve conduction

The speed and strength of a signal being transmitted by nerve cells. Testing these factors can reveal the nature of nerve injury, such as damage to nerve cells or to the protective myelin sheath.

Neurotransmitter

Chemicals within the nervous system that transmit information from or between nerve cells.

Peripheral nervous system (PNS)

Nerves that are outside of the brain and spinal cord.

Sensory

97

97

of 114

Refers to peripheral nerves that transmit information from the senses to the brain.

FOR YOUR INFORMATION

The Essay Author is Julia Barrett.

MEDIA REPORTS

Here are three recent Media Reports on the admitted to flaws of the Gold Standard the White House and the Department of Veterans Affairs uses in denial of compensation for morbidity and mortality associated with Herbicide Exposures.

In one finds that the comparison group was tainted in the finding of cancers then certainly statistics used for other medical issues found and then denied based on faulty cohort assumptions would be just a flawed.

Instead of comparing apples to oranges as the study was supposed to do. The study now finds it has been comparing apples to apples and oranges to oranges and the outcomes were predictable. There is little difference if any that would have been identified as to what Vietnam Veterans, their widows, and the orphaned and damaged offspring have been saying for 40 years now.

Exactly what the White House, The Department of Veterans Affairs, and even some our elected Congress wanted them to find – VERY LITTLE.

98

98

of 114

MEDIA ONE

Agent Orange study findings called flawed Two scientists involved in 25-year, $140 million study say it may underestimate cancer risks for Vietnam vets

By Clark BrooksSTAFF WRITER

A design flaw in the federal government's $140 million study of the health effects of Agent Orange on Vietnam veterans has resulted in a quarter-century of inaccurate findings, two scientists involved with the study told The Greenville News.

Begun in 1978 to help settle compensation claims, the Air Force Health Study will end

99

99

of 114

this week as it began, in controversy, with tens of thousands of veterans still seeking answers to chronic illnesses they attribute to herbicides used during the Vietnam War.

Agent Orange and other herbicides sprayed in Vietnam to destroy enemy crops and jungle cover contained cancer-causing dioxin. The U.S. Air Force, however, is closing up shop on the study having found no increased incidence of a serious illness other than diabetes.

The study has compared airmen directly involved with the spraying missions, called Operation Ranch Hand, to Air Force veterans who served in Southeast Asia but had no role in spraying.

However, hundreds in the comparison group spent time in Vietnam and may have been exposed to herbicides, too, said Joel Michalek, who worked on the study from the beginning and was its principal investigator for 14 years until he left in May.

"It spoils everything," Michalek told The News. "It's as if you're running a clinical trial on a new medication, and you found out some of the people who were in your placebo group were actually taking meds. That would spoil your whole study. And that's what's going on here in this study."

Michalek co-authored two articles published in the Journal of Occupational and Environmental Medicine in 2004 and 2005 that found significant rates of cancer in the Ranch Hand and comparison groups.

Air Force spokesman Ed Shannon declined to make officials available for comment. Shannon was asked why Michalek's analysis published in the Journal showing cancer trends in the comparison group of veterans was not used in the analysis for the final Air Force report published last year.

The Air Force noted in an e-mail reply that a "recently published analysis" showed an increased cancer risk in Ranch Hand and comparison veterans. Shannon said Saturday there would be no further Air Force analysis.

In a follow-up e-mail, the Air Force said the final report included only the veterans who attended the last round of medical tests in 2002 and that all physical examination reports follow the same basic analytical plan.

Michalek's finding of cancer in the comparison group was not used in the analysis for the Ranch Hand report.

Michalek said he followed up on the cancer articles with an analysis that allowed for the exposed control group and other factors and found a doubling of cancer in the Ranch Hand group.

100

100

of 114

Further research needs to be done to strengthen these findings and figure out what other diseases the Air Force scientists may have missed because of the exposed comparison group, Michalek said.

The comparison veterans, he said, are similar to average Vietnam veterans, from nurses to truck drivers, who spent most of their time in base camps. The comparisons' data also should be studied further, he said.

The results could matter greatly to thousands of Vietnam War veterans who've never received compensation for debilitating illnesses that earlier Ranch Hand study findings said couldn't be linked to Agent Orange.

A Department of Veterans Affairs analysis in 1998 found 92,276 Agent Orange claims for compensation had been filed by veterans and their survivors. Of those, 5,908 had been approved.

The analysis was done before diabetes was added to the list of diseases eligible for compensation, which would make both columns much higher today, said Jim Benson, a VA spokesman. {My comment would be Jim Benson is defending the low approval rate, which would reflect White House mandated Budget Control – NOT JUSTICE!}

The VA no longer tracks Agent Orange claims because many veterans apply for more than one type of compensation per claim, he said. {Another misleading statement by Mr. Benson.}

The Ranch Hand study has followed about 1,000 Ranch Hand veterans and some 1,300 comparison airmen who served in Southeast Asia.

Although the study will end Saturday for the Air Force, legislation pending in Congress would turn over all the data and specimens to the Institute of Medicine's Medical Follow-up Agency, which would collaborate on analyses with scientists outside the government. {Just think another 25 years of study until all Vietnam Veterans are dead.}

Michalek left his civilian Air Force job for the University of Texas Health Science Center in San Antonio. He said he would apply on behalf of the school to be a collaborator.

Greer soldier sprayed

The U.S. military sprayed more than 18 million gallons of herbicides over 3.6 million acres of South Vietnam from 1962 to 1971. Nearly two-thirds of it was Agent Orange.

Richard Leoffels of Greer saw the planes spraying overhead when he was an Army infantryman with the 1st Cavalry Division in 1968-69. Sometimes the wind blew it onto

101

101

of 114

him and his buddies as they set up for ambushes, he said.

He didn't give it much thought, he said, even as he occasionally crawled through areas saturated with herbicides. He was more concerned about the enemy.

"I didn't know anything about Agent Orange until I came back, did some reading and saw a couple specials on TV," he said.

Red blotches appeared on his legs in 1969, just a minor annoyance, he said. Later, he would suffer a litany of more serious conditions.

The Air Force has announced in periodic updates since 1984 that the Ranch Hand veterans are about as healthy as the comparisons and have no significant increase in cancer or heart disease or any other serious illness except diabetes.

Ranch Hand and comparison veterans were thoroughly examined every three to five years, beginning in 1982. The results were recorded in thick Air Force reports.

The final one of those, published last year, presented the results from the sixth and last round of testing, conducted in 2002. It concluded the cancer analysis "did not suggest an adverse relation between cancer and herbicide exposure."

Ron Trewyn, a biochemist and member of the Ranch Hand study advisory committee, reviewed that report's cancer chapter.

He argued strongly during advisory committee meetings that the cancer chapter should include all the cancer data used to write the 2004 and 2005 articles in the Journal of Occupational and Environmental Medicine. It didn't happen, he said.

"They referenced those papers, but they left all the data out from those cancer papers that were done that showed the cancer effects," he said. "It's huge, because then the conclusion is there's no cancer effect, when as part of the study, the same investigators, just analyzing the data in a different way, found that when they did that, lo and behold, then there were significant cancer effects.

"And so for the final report to say there's no cancer effect when the investigators themselves published papers saying there is a cancer effect, that's just flat scientifically wrong."

Without factoring in the new information about the comparison veterans, Trewyn said, the Air Force got the same, predictable results.

"When they use an exposed control group and they say the two groups have roughly the same amount of cancer and so forth, what is that finding good for? Nothing," said Trewyn, vice provost for research and dean of the graduate school at

102

102

of 114

Kansas State University.

And it doesn't take a scientist to figure that out, he said.

"This is common sense now, a lot of it," he said. "It's like now wait a minute. This just does not pass the smell test or the common sense test."

Trewyn, who said he began wondering about exposures in the comparison group in 1999, did cancer research for 20 years.

Because many comparisons were exposed to the same environmental conditions as the Ranch Hand veterans, all major health outcomes need to be re-examined, he said.

"There have been industrial studies related to dioxin where as they looked back at it they thought they had a few exposed in the control group and so the statistics went to hell," he said.

In the Ranch Hand study, it's more than a few. At least 600 members of the comparison group spent time in Vietnam, Michalek said.

New rates found

Michalek said the breakthrough that led to the new data analysis came when he started to look not just at the numbers but also at the men behind them. Where in Southeast Asia did the Ranch Hand and comparison veterans serve? For how long?

He learned some Ranch Hand veterans didn't take part in spraying because none was done while they were there, and those who served earlier in the war had higher levels of dioxin.

When he factored in that information along with the exposed comparison group, Michalek said he found a doubling of cancer among Ranch Hand veterans with the highest dioxin exposures. He also found cancer increasing with dioxin exposure, the first time such a trend has been seen in the Ranch Hand study, he said.

Michalek said he also found a stronger showing than previously for diabetes.

Advisory committee members wanted him to get the new cancer and diabetes findings published in a scientific journal, and he told them he intended to, according to minutes from the June 2005 committee meeting.

However, Col. Karen Fox said during the committee's final meeting this month in

103

103

of 114

Rockville, Md., that the Air Force has no plans to publish the new findings in any Air Force report or scientific journal, The News reported earlier this month.

Fox, responding to extensive questioning from advisory committee members, said the Air Force told Michalek to destroy the data.

Fox, who succeeded Michalek as principal investigator of the study, declined to be interviewed by The News during breaks in the meeting.

She said during the meeting the Air Force "tried to enter into a relationship" with Michalek to write the cancer and diabetes papers, but "he elected not to do that."

Michalek said the Air Force told him he would have to contract with Science Applications International Corp., which does data analysis for Ranch Hand study reports. He said he negotiated with SAIC but wasn't hired.

Maurice Owens, a project manager for SAIC, told The News the company decided it would be a conflict of interest to work with Michalek because he had been a scientist for the Air Force.

There is precedent for such a hire, however. Col. George D. Lathrop, who helped design the Ranch Hand study, moved to SAIC during the 1980s after he retired from the Air Force.

Owens said he couldn't comment on that.

Michalek said he began writing the cancer paper without pay. He said he finally gave up when he got a letter from the Air Force dated July 6, 2006, ordering him to delete the data.(Now the above statement is what Government Justice is for its Nations Vietnam Veterans “DELETE THE INCRIMINATING DATA.” SOUNDS LIKE PRE WAR GERMANY CIRCA 1939 FOR CHRIST SAKES!} {CONGRESS ALLOWS THIS INJUSTICE TO CONTINUE TO THIS DAY.}

Rick Weidman, who has monitored the Ranch Hand advisory committee meetings for Vietnam Veterans of America, said he believes the Air Force had no intention of letting Michalek write the cancer paper on his own.

"They didn't want him to publish because they wanted to be able to censor it," Weidman said. "That's just plain as day to us."

Getting compensation

Because Ranch Hand study reports had said the health of the Ranch Hand and

104

104

of 114

comparison veterans was about the same; some members of Congress sought other ways to settle compensation claims. The Agent Orange Act of 1991 established a compensation list.

The first entries were non-Hodgkin's lymphoma, soft-tissue sarcoma and chloracne, a skin condition. The act also authorized the National Academy of Sciences to evaluate dioxin research from a host of studies, mostly of civilians.

Using the results of that research, the Department of Veterans Affairs has added nine diseases, mostly cancers.

Leoffels suffered his first of three strokes in 1998. They were minor as strokes go, but for a time, he couldn't control his left leg.

He was working as a letter carrier for the post office, a good job, he said, but not one a person can stagger through.

"People were calling the post office and saying, 'Hey, the mailman is walking around drunk,'" he said.

Circulatory disorders are on the long list of diseases and conditions for which the NAS has not found enough evidence of a dioxin association to be included for compensation.

Leoffels, 58, does receive compensation for type 2 diabetes, he said, $112 a month. It's the one illness on the list that might owe its spot to the Ranch Hand study, said David Tollerud, an epidemiologist who headed the NAS research during the 1990s.

Spina bifida, a birth defect, is the only other condition on the list that received an assist from the Ranch Hand study, he said.

'Flawed design'

Tollerud, a professor of public health at the University of Louisville, chaired the IOM panel that recently recommended the Ranch Hand data and specimens be saved for study outside the Air Force.

He briefed the Ranch Hand advisory committee during a meeting in February. He called the biological specimens accumulated over 25 years "a trove of valuable research material," according to the minutes from that meeting.

Tollerud also pointed out some study limitations, including the study's "flawed design and execution" and "potential herbicide exposures in the comparison populations," the minutes show. {Just as the author of this challenge Charles Kelley did in 2004 in Washington, DC.}

In an interview with The News, Tollerud said his comments were not meant to be

105

105

of 114

condemning but to recognize limitations that future researchers need to take into account.

As for the exposed comparison group, he said, "The general result of that kind of a complication in a study design would be to do what we call bias it toward the null, meaning that it might make it less likely that you would observe findings that were really there."

Leoffels said he is in favor of continuing the Ranch Hand study as long as it is done outside the Air Force.

"Why throw away $140 million?" he said.

Leoffels said he lost his job as a letter carrier to post-traumatic stress disorder. The VA compensates him for it, offsetting what he believes he should be getting for Agent Orange damage, but isn't.

He helps other vets navigate the VA, though many get discouraged the first time they are turned down and never go back, he said.

Leoffels said it shouldn't be so difficult for veterans to get the help they need.

"I think what the government wants is for us to die off so they don't have to pay us anything," he said.

106

106

of 114

MEDIA TWO

Agent Orange cancer findings won't get in report, Air Force saysStudy's chairman raises questions about decision to leave data out

Published: Sunday, September 10, 2006 - 6:00 am

By Clark BrooksSTAFF WRITER

ROCKVILLE, Md. -- Cancer findings described as potentially significant by the chairman of an advisory committee won't be in the final report of a 25-year government study of the effects of Agent Orange on Vietnam veterans. The $140 million study of airmen who sprayed herbicides in a series of missions called Operation Ranch Hand was designed to be used as a basis for compensation for thousands of veterans. It ends Sept. 30. The analysis showed a doubling in cancer rates among the highest-exposed veterans, according to information submitted to the advisory committee. The Air Force has no plans to publish the new cancer findings in any Air Force report or scientific journal, Col. Karen Fox told the civilian advisory committee during a meeting in Maryland in response to spirited and sustained questioning during the panel's final meeting Thursday. Fox said the Air Force instructed the scientist who conducted the analysis to destroy the data.

107

107

of 114

Michael Stoto, committee chairman and a professor at Georgetown University, said the new analysis included "some interesting and potentially important findings" about the health of airmen involved in herbicide spraying missions during the Vietnam War. "Frankly," Stoto said at one point in the hearing, "when it shows a significant finding and it seems to have been suppressed, that doesn't add credit to the study.” However, Stoto said later in the hearing he perhaps should not have used the word "suppressed." In an interview during a break in the meeting, Stoto said the discussion was triggered by questions The Greenville News posed to him about the status of the unpublished data the week before the meeting. The U.S. military sprayed 18 million gallons of herbicides over 3.6 million acres of South Vietnam from 1962 to 1971 to destroy enemy crops and hiding places and to clear areas for American base camps. The majority of it was Agent Orange, which contained cancer-causing dioxin. Agent Orange and other herbicides, some of which also were tainted with dioxin, were named for the color of the stripe around their 55-gallon storage drums. Sapp Funderburk, an Air Force veteran who lives in Taylors, recalls loading orange-striped drums on aircraft in 1969 when he was an airfreight sergeant in charge of special handling at Phu Cat Air Base. "They told us they were Agent Orange, so wear these gloves," he said. "They were big, heavy rubber gloves like you see in a science fiction movie." Funderburk, who was diagnosed with cancer of the larynx in December 2001, said that in the tropical heat and humidity, the instant he lowered his hands, the gloves slid off. He had to unscrew a plug to open a hole to relieve the pressure in the drums, he said, and Agent Orange sloshed over him. Veterans complaining of health problems they said were caused by Agent Orange began filing claims in the late 1970s, and Congress funded the Ranch Hand study to investigate the health effects of herbicides. The study, also known as the Air Force Health Study, began in 1982. Although the study is ending for the Air Force, the Institute of Medicine wants the government to preserve the data sets and frozen biological specimens of about 1,000 Ranch Hand veterans and 2,000 comparison airmen who did not spray herbicides. A recent IOM report said the materials are valuable and should be studied further.

108

108

of 114

Legislation pending in Congress would turn everything over to the IOM's Medical Follow-up Agency, which would collaborate on analyses with other scientists and research centers. The Air Force scientists never reported significant incidences of cancer in any of the study's periodic reports on the participants, who were examined every three to five years. Nor has the Ranch Hand data ever yielded a finding of cancer increasing with dioxin exposure until the new analysis that was the topic of discussion at last week's advisory committee meeting. That analysis showed a doubling of cancer among Ranch Hand veterans who have the highest blood-serum levels of dioxin. Committee members were aware of the findings because the work was done by Joel Michalek, a civilian scientist with the Ranch Hand study from the beginning and its principal investigator for 14 years. Stoto said in an interview the week before the meeting that the cancer analysis, which Michalek presented to the advisory committee in a June 2005 meeting, "really needs to be published." Michalek's data analysis, as detailed on slides presented at that meeting, shows cancer increasing with dioxin exposure. A separate analysis showed a stronger diabetes finding among Ranch Hand veterans than previously, Michalek said. Ranch Hand scientists reported a significant risk of diabetes among exposed veterans seven years ago. Michalek, who did not attend the meeting, told The Greenville News he did the analyses before he left the Air Force in May 2005 for a job as a professor at the University of Texas Health Science Center at San Antonio. He said he wants to use a similar approach to examine a variety of other health outcomes in the Ranch Hand group. In his cancer analysis, Michalek said he took into consideration that there were intervals during the war when no spraying was done, and that Agent Orange and other herbicides may have been more heavily contaminated with dioxin earlier in the war. Fox, who succeeded Michalek as principal investigator, told the advisory committee she had doubts about his analyses. "I don't think there was a hypothesis before he started crunching the data," she said. Michalek disagrees. "We tried to question all of our assumptions and incorporate external information about the war to once again test the underlying hypothesis that exposure to Agent Orange may be related to the risk of cancer," he said. "I hope the new custodian will

109

109

of 114

find a way to give other researchers access to the study material so these methods and results can be peer-reviewed." Fox, responding to questions from the advisory committee, said that in spite of her misgivings about Michalek's analyses, the Air Force tried to work with him on the cancer and diabetes papers after he left, but Michalek didn't follow through. "We tried to enter into a relationship with him for him to write those papers," Fox said. "He did not do that." Michalek said he negotiated with Maurice Owens, a project manager for Science Applications International Corp., which is under contract to do data analysis for Ranch Hand study reports. Owens, who attended the advisory committee meeting last week, told The Greenville News that SAIC decided working with Michalek would be a conflict of interest because he had been a scientist for the Air Force. Michalek said he has since done as ordered and deleted the Ranch Hand data that was in his possession. Fox declined to be interviewed during breaks in the meeting. Ron Trewyn, a biochemist and member of the Ranch Hand study advisory committee, said during the meeting that if Michalek had left one university for another, he would have been able to complete unfinished research papers. He asked Fox why Michalek couldn't do that for the Air Force. The scientist is "more than welcome" to talk to whatever entity winds up as custodian of the data and specimens, Fox said. Trewyn, a Vietnam veteran, said in an interview that getting the new cancer analysis published is important to veterans who are not yet being compensated for cancers and other illnesses related to their service in Vietnam. The Agent Orange Act of 1991 established a compensation list. The first entries were non-Hodgkins lymphoma, soft-tissue sarcoma and chloracne, a skin condition. The act also authorized the National Academy of Sciences to evaluate medical and scientific data about the health effects of dioxin exposure from a host of studies, mostly in the civilian population. Based on NAS research, the Department of Veterans Affairs has added nine diseases, among them diabetes and respiratory cancers, which include cancer of the larynx. Prostate cancer and multiple myeloma are also on the list. Among those the NAS is studying that have not yet made the list are bone cancer, melanoma, testicular cancer, urinary bladder cancer, breast cancer, and most leukemias.

110

110

of 114

The Department of Veterans Affairs no longer keeps statistics on Agent Orange claims because of variables such as veterans applying for more than one type of compensation per claim, said Jim Benson, a VA spokesman. The San Diego Union-Tribune reported in 1998 that 92,276 Agent Orange claims had been filed by veterans and their survivors, and 5,908 of them had been approved. Funderburk, the Taylors veteran, receives compensation in the form of monthly checks from the VA. Nevertheless, he thinks it's unfair that thousands of other Vietnam veterans with cancer are not getting help. Trewyn, vice provost for research and dean of the graduate school at Kansas State University, said cancers caused by exposures in Vietnam could show up anywhere.

"Some people are going to be susceptible to one type of cancer versus another," he said. "Having done research on cancer, it doesn't surprise me AT ALL THAT YOU FIND THIS AT A WHOLE HOST OF DIFFERENT SITES." Or, as Funderburk put it, "To me, cancer is cancer is cancer."

111

111

of 114

MEDIA THREE

AGENT ORANGE EXPOSURE TIED TO ILLS IN VIETNAM VETSThu Nov 9, 10:49 AM ET

NEW YORK (Reuters Health) - Vietnam veterans who sprayed the herbicides like Agent Orange decades ago in Vietnam are at an increased risk of developing heart disease, diabetes, high blood pressure, and chronic breathing problems, a new study shows.

Agent Orange, a week killer containing dioxin, was widely used during the Vietnam War, Dr. Han K. Kang of the Department of Veterans Affairs in Washington, DC and colleagues note in the American Journal of Industrial Medicine. Overall, two thirds of the herbicides used during the conflict-contained dioxin. To understand the long-term effects of exposure to the chemicals, Kang and his team compared 1,499 members of the US Army Chemical Corps to 1,428 vets who had worked in chemical operations jobs but did not serve in Vietnam. The Chemical Corps members had been responsible for spraying herbicide around base camp perimeters, as well as aerial spraying of the chemicals from helicopters. Study participants were surveyed by telephone in 1999 and 2000. Tests of a subset of the study participants, including 795 Vietnam vets and 102 non-Vietnam vets, showed the Vietnam vets had higher levels of dioxin in their blood.

112

112

of 114

The researchers analyzed the effects of Vietnam service and herbicide exposure separately, and found that hepatitis was the only health problem linked to serving in Vietnam per se. {Veterans are still not compensated for liver problems or liver disease associated to Agent Orange or Service in Vietnam. To the Veterans and their spouses it makes little difference how the VA or the congress wants to associate the liver problems as associated for mortality and morbidity compensations. It seems to be only an excuse not to compensate even though data proves the Vietnam Veterans was correct all along and that by at least 5 to 1 in increased liver mortality and morbidity than the rest of the United States Population.} However, exposure to herbicides among Vietnam veterans conferred a 50 percent increased risk of diabetes, a 52 percent greater heart disease risk, a 32 percent increased risk of hypertension and a 60 percent greater likelihood of having a chronic respiratory problem such as emphysema or asthma. An increased cancer risk also was seen among the Chemical Corps members, but this was not significant from a statistical standpoint. "Almost three decades after Vietnam service," the researchers conclude, "US Army veterans who were occupationally exposed to phenoxyherbicide in Vietnam experienced significantly higher risks of diabetes, heart disease, hypertension, and non-malignant lung diseases than other veterans who were not exposed to herbicides.”

You will notice the VA is very careful in stating non-malignant lung disease and not using the medical term Chronic Obstructive Pulmonary Disorder (COPD) that has been found in dioxin exposures as well as Vietnam Veterans. While the concert of VA and BVA directed by our White House has continuously denied this disease of the processes associated with pulmonary functions.

SOURCE: American Journal of Industrial Medicine, November 2006.

113

113

challenge to the president, secretary of ... · web vieweditors of cell put the toronto researchers...

Documents