1
Page 1 of 114
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!
The united States campaigning “army of Vietnam” and its widows and orphans
deserve “deeds”
not “words” from our government
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.
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.
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 Kelley
2078 Eastwood Drive,
Snellville, GA 30078
Cell: 404-641-6477
Subject: The government CONTROLLED and funded Ranch Handstudyof 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”)
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
Veterans' Statements
- The Veterans shall establish SCIENTIFIC, statistical, and MEDICALevidence 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 Herbicideexposure but also many of the other toxic chemicals to which he/she was exposed. (Brock v. Brown, 10 Veterans Appeal155 (1997). (McCartt v. West, 12 Veterans Appeal164 (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 handstudy 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.
[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 which “Veterans affairs has found” a positive association exists betweenthe 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.”
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.”
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.
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 illogicalVA 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.
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.
- 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.