OFFICIAL SUBMITTAL FOR THE DISABILITY COMMISSION RECORD

 

veterans Disability Commission July 18 - 20

Washington Plaza Hotel, Washington, DC

 

IOM DISCUSSIONS on Presumptive herbicide or service in Vietnam Disorders, ISSUES, concerns, AND QUESTIONS

by

Charles Kelley and interested Veterans and Widows of Veterans

 

 

Opening statements

 

The search for latent illnesses and disorders causing mortality and morbidity issues associated with exposure to “herbicides” (plural) in our toxic chemical legacy demands persistence, confronting hard truths, and above all integrity. The United States Government has failed miserably in these issues.   Historically this has been the case in these mass Veterans Issues from WW1 on up to present day Gulf War Syndrome.

 

Obviously, we cannot get into every toxic chemical disorder or syndrome that we think is appropriate “as presumptive” in one day.  We should however, discuss some of the processes involved and we will be giving examples of how the issues we think should be looked at and get your opinion as to the appropriateness and reasons why you obviously disagree since we seemed to be at two ends of scientific findings and "levels of proof and standards."   We will give examples of a typical disorder that we think "is beyond presumption" and if you could apply that to your government constraints and tell us how this is not presumptive then we may have a better understanding of what you are mandated to do or evaluate.

 

“The Agent Orange Act of 1991, Public Law 102-4,105 Stat. 11, directed the Secretary to seek to enter into an agreement with the National Academy of Sciences (NAS) to review and summarize the scientific evidence concerning the association between exposure to herbicides used in support of military operations in the Republic of Vietnam during the Vietnam Era and each disease suspected to be associated with such exposure.  Congress mandated that NAS determine, to the extent possible: 

 

(1) Whether there is a statistical association between the suspect diseases and herbicide exposure, taking into account the strength of the scientific evidence and the appropriateness of the methods used to detect the association;

 

(2) The increased risk of disease among individuals exposed to herbicides during service in the Republic of Vietnam during the Vietnam Era; and

 

(3) Whether there is a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and the health outcome.

 

Section 2 of Public Law 102-4, codified in pertinent part at 38 U.S.C. 1116(b) and (c), provides that whenever the Secretary determines, based on sound medical and scientific evidence, that a positive association (i.e. the credible evidence for the association is equal to or outweighs the credible evidence against the association) exists between exposure of humans to an herbicide agent (i.e. a chemical in an herbicide used in support of the United States and allied military operations in the Republic of Vietnam during the Vietnam Era) and a disease, the Secretary will publish regulations establishing presumptive service connection for that disease. If the Secretary determines that a presumption of service connection is not warranted, he is to publish a notice of that determination, including an explanation of the scientific basis for that determination.  The Secretary's determination must be based on consideration of the NAS reports and all other sound medical and scientific information and analysis available to the Secretary.

 

Section 2 of the Agent Orange Act of 1991 provided that the Secretary's authority and duties under that section would expire 10 years after the first day of the fiscal year in which NAS transmitted its first report to VA.  The first NAS report was transmitted to VA in July 1993, during the fiscal year that began on October 1, 1992.  Accordingly, VA's authority under section 2 of the Agent Orange Act of 1991 expired on September 30, 2002.  In December 2001, however, Congress enacted the Veterans Education and Benefits Expansion Act of 2001, Public Law 107-103.  Section 201 (d) of that Act extended VA's authority under 38 U.S.C. 1116(b)-(d) through September 30, 2015.

 

Although 38 U.S.C. 1116 does not define "credible," it does instruct the Secretary to "take into consideration whether the results [of any study] are statistically significant, are capable of replication, and withstand peer review.”

 

The Secretary reviews studies that report a positive relative risk and studies that report a negative relative risk of a particular health outcome.  He then determines whether the weight of evidence supports a finding that there is or is not a positive association between herbicide exposure and the subsequent health outcome.

 

The Secretary does this by taking into account the statistical significance, capability of replication, and whether that study will withstand peer review.  Because of differences in statistical significance, confidence levels, control for confounding factors, bias, and other pertinent characteristics, some studies are more credible than others.  The Secretary gives weight to more credible studies in evaluating the overall evidence concerning specific health outcomes.

 

IOM members and Disability Commission Members  “must realize” our Veterans have been fighting for 40 years now and still are fighting for their very lives from these toxic chemical exposure damages. The financial and economic toll is great to the Veterans and their families.

 

The members here also must realize the amount of money and the industry the government is trying to protect.  There is a very large potential for a “conflict of government interest” at the expense of the Veteran Community for these government mistakes made by the Johnson Administration. 

 

Based on the work that has been done the last 40 years we need to be honest with our Vietnam Veterans.

 

"By the time the scientific data is known, you are dead.  You will either have “died early” or you will have “died in your old age in pain,” but you will not get help from the Federal Government." (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 - Congressman Shays)

 

There cannot be the usual condition of “no shadow of doubt” (not even required by a court) as these multiple toxic chemical issues are for too complex to try to untangle the web of "cause and effect" on so many organic systems in so many widely variant human beings who all happened to be in Vietnam during a certain set of years. However complex, the IOM owes it to every Vietnam Veteran to spend the time, energy, and resources to give Vietnam Veterans what they need and deserve in fairness while wrestling with bodies which are now wounded by toxic chemical exposure(s) and now also the ravages of time.

 

Should we have “no shadow of doubt” in this multiple toxic chemical issues with a wide combination of chemicals and wide forms of exposures or combination of exposures that no one knows “including the IOM” how these toxic chemicals create the many systemic issues?

 

Should we have the “presumption processes” so restrictive as to make sure that the one or two Veterans in comparison that would have developed these presumptive disorders without toxic chemical exposures are denied death or disability compensations?  While at the same time then denying those hundreds of thousands of our nations warriors who were directly either killed or disabled for life by the mistakes of our own military and then compounded by the ruling government.

 

The Executive Branch/DOD/VA seems to say yes to allowing veterans to have to prove their cases above and beyond a shadow of doubt to qualify for meager compensation and to get health care for the subtle effects that profound chemical exposures made on their bodies while young and robust. 

 

Unfortunately, the Feres Doctrine and USC 38 paragraph 511 have already created (in our opinion) a formidable obstacle for veterans to overcome in order to obtain justice for the compromises of their bodies and systems that they (through no part of their own), did not ask for or deserve, and for which health care providers seldom encounter. 

 

The obstacles mentioned complicate the rendering of justice in these cases, and we realize that the Feres Doctrine and USC 38 paragraph 511 of the Federal Code is not necessarily ‘the fight’ of the IOM, but you must be aware of the “implications” and how these are intertwined in “setting aside the citizen” once that citizen wears the uniform of the United States Military.

 

During a congressional oversight committee meeting in 2000 when members of congress asked Dr. David Butler, Senior Program Officer, Veterans and Agent Orange Reports, Institute of Medicine, National Academy of Sciences, National Academy of Science Program Manger was 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 come to the conclusion, 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 have died early or you will have died in your old age in pain, but you will not get help from the Federal Government."

 

Dr. Butler's answer was: 

 

"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."

 

Mr. Shays. "And so you choose not to offer an opinion?"

 

Mr. Butler. I don't feel it's my role as a study director to offer a policy opinion.

 

Mr. Shays. Now you have an opportunity to make a contribution separate. That is not unusual. We get witnesses

here and we say my God, you have worked on this for years. You are restrained by your science and you are going to follow that, you have an opportunity.    And you refuse to give an opinion?

 

Mr. Butler. I appreciate the opportunity, Mr. Shays. In my role as the person who facilitates this study, it's my belief

that I do that job best if I act as a neutral, unbiased conduit of information to the expert committees that are formed by the National Academy of Sciences who come to the decisions that are made in these reports.

 

Mr. Shays. And therefore, you have decided not to answer that question?

 

Mr. Butler. That's correct.

 

This Disability Commission must recognize this as nothing but NAS/IOM - Veterans Affairs word game.
 

We have a premier group of scientists contracted to determine presumptive associations and will not answer the simple question of at what confidence level do they determine "any associations."

 

Veterans are denied the rights of even the illegal or the terrorists and we still are willing to fight for our rights given we know what the rules are.  We cannot fight the changing rules of our government in levels of association or when a pivotal epidemiological study shows a connection to a disorder "as significant" the rules change as in, Well the study exposure index must have been wrong therefore we change the rules and the low and behold the data now shows a low end significance.   That as they say, "is nothing but dirty government pool."

 

Veterans Affairs then steps up in the committee meeting to discount the findings and corruption found in Ranch Hand and states:

 

"Veterans Affairs agrees that these and other limitations in the Ranch Hand study noted by NAS over the years 
have made its impact on VA determinations very limited."  

(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 - Congressman Shays)

 

NAS/IOM has made statements in the past while they used other studies in review also, they primarily used the Ranch Hand to determine presumptive associations as well as category of presumptions.  It should be noted here also that Ranch Hand actually briefed NAS/IOM in person.

 

A government paid for pivotal 140 million dollar study is not used by VA at all or limited in assigning compensations for death and disability; yet, the premier group of scientists who are contracted to recommend to the governments legal body, Veterans Affairs, indicates it is used for that very purpose of making recommendations to compensate or not compensate.

 

Again, this Disability Commission must recognize this as nothing but NAS/IOM - White House controlled Veterans Affair's word games.

 

Veterans and widows of Veterans cannot fight this government biased system with data and evidence unless we know the rules of engagement.  If the rules of engagement and proof keep changing then we are not even given a chance.

 

That is what our government has done for almost a half century now in these mass Veteran Issues.  

 

The IOM, by default, may be part of this biased government process, of setting aside the Veteran Citizen, unwittingly, when they conduct  literature reviews, analysis of data, and conclusions by setting such high, "unreachable standards" during evaluations.

 


     

overview ISSUES

 

It took 27 years for our own government to admit the very first mortality disorder in our Vietnam Veterans from their legacy of Rainbow Herbicide Toxic Chemical exposed to them during service in the war theater.  Tens of thousands of our warriors died without service connection, compensation, or effective health care.  Many continue to die without service connection, compensations, or even warnings. And that last word is vitally important--- just to be forewarned, so that personal health habits are adjusted and implemented as soon as possible. Veterans who never receive those warning messages ‘You might be at risk for…… or ………’, are unable to fully understand the scope of their health risk and take steps to safeguard against those same risks.

 

Many Vietnam Veterans believe the only reason why this first event took place was the uncovering of the manifesto from the Reagan/Bush Office of Management and Budget ordering all the 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:

 

A)    The cost of supporting the Veterans and

B)    The court liability to which corporations would be exposed.

(Taped interview by Moon Callison with Admiral Zumwalt on July 26th 1999 discussing his role in the 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.  (America’s Defense Monitor (ADM's) Moon Callison interviews the former Chief of Naval Operations, for "Environmental Impact of War").

 

One of the reasons that their health risks have not been adequately identified, treated and compensated are purely economic in nature.

 

Many Veterans and Veterans families also believe the VACEH, as well as the IOM have been part of an integral plan of this economic issue.  One investigative news reporter suggested the following:

 

"The academy also cherry picks it's studies and due to the source of it's funding pretty much is a biased sham entity to begin with. In short, it would cost too much money to tell the truth about the adverse health effects...  (author Gary Matsumo in his highly acclaimed book "VACCINE A".)"

 

There are many Veterans, there are some members of Congress, there are many Americans who believe the Department of Defense (DoD) and the Veterans Administration (VA) have been less than candid about the health effects that Agent Orange, Agent Orange II, (Super Agent Orange) or any of the other “Rainbow Herbicides.  Whether these toxic agents are studied individually or in combination of the synergy of multiple combinations that has had on them, And, these toxic effects are not just on themselves, but are suspected of leaving a toxic footprint on the offspring of many Vietnam Veterans.  (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 - Congressman Lane Evans)

 

The historical facts in this issue since the beginning has not been without government agency mandated biases, chemical company interference, and less than “scientific independence” for government funded studies. 

 

The Ranch Hand funded studies have been accused by their own principal scientific members with evidence and statements of “scientific misconduct.” Including statements that the study has never given the Veterans a "fair assessment" of their health issues. (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 - statements by Doctor Albanese, Principal Ranch Hand Scientist)

 

Some concluded that entire chapters were rewritten to de-emphasize the documented medical issues found.  (Ranch Hand transcript – August 1999) 

 

While some have concluded that there is important data, found by the Ranch Hand in "50% or more increases" in medical issues that were not and have not been brought forward.  This government study is charged with crafting for publication and peer review and not publishing medically and statistically found dioxin issues. The study is criticized for the use of “command influence”, which seems to extend to the Surgeon General and the Air Force changing “concluding medical statements” after they were cleared for publication (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 - statements by Doctor Albanese, Principal Ranch Hand Scientist)

 

The studies own scientists have question if this was a “dioxin study” or “a government exoneration tool.”  (Ranch Hand transcripts) 

 

Senator Daschle categorically stated the changes reflected in the 1984 scientific draft versus the published Ranch Hand were not just a disagreement over the facts but the publication of “fraudulent government conclusions.”  Once again some scientists with integrity coming forth in 1987 stating the drafts were changed and there was more found than reported. (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.)

 

The General Accounting Office (GAO) has stated, Ranch Hand has been slow to publish findings, unwilling to share data, inconsistent in conveying design limitations, and resistant to congressionally mandated participation by independent parties.” (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 - Congressman Shays)

 

These are significant statements as they portray at best a certain disregard for research integrity, but also may signify something else--- possibly criminal in nature.  These are not good endorsements for what is being held up as the “Gold Standard” for dioxin studies, not just in our own nation but in our allied nations as well. 

 

The Ranch Hand study has been consistently criticized for both scientific and administrative shortcomings.  Many believe Ranch Hand has so far failed to fulfill its promise as the pivotal longitudinal study of herbicide toxicity.  Some conclude it never will.  Others believe this research was designed to fail, or manipulated to “avoid controversial findings.”  (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 - Congressman Shays)

 

Recently Doctor Joel Michalek our own Department of Defense's lead scientists on the Ranch Hand Study for 14 years confessed that the study is so flawed to the point it missed a two fold increase in all cancers.  This is not just some "oops" and can be explained away.  Legal government decisions have been made on this study for decades that affect not only the Veteran but a surviving spouse and children as well.   The nature of this flaw now renders all findings for 25 years at risk.  Findings that were not relevant or of significance would be at risk and certainly medical findings of low significance could be in the high end of relevancy as to compensations awarded for disability and/or death caused by the Johnson Administration.

 

A two time member of the Ranch Hand committee, Dr. Trewyn stated regarding the oversight of the cancer finding: 

"It is important to veterans who are not yet being compensated for cancers and other illnesses related to their service in Vietnam."

 

The Air Force's response to this new finding was "to destroy the data" and that they were not going to address the new revelations of significant flaws.

  

The VA funded study of Army Chemical Corps workers when announcing they found little difference in the cohorts does not indicate the cohorts were “both involved” in the spraying of toxic chemicals.  One was involved in Vietnam and one was in the United States.  This would conclude the study was for the difference between Vietnam and the United States and not the effects of the toxic chemicals. 

 

(Note:  The Ranch Hand transcripts show that one of the stand up scientists recommended the use of clean non-toxic chemical Veterans be used in the cohort comparison.  When the study was asked why they did not comply.  The indication was, because the IOM in their recommendation of this Chemical Corps worker study did not actually specify that “as a study requirement.”) (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)

 

Yet, when one looks at the actual findings of the VA's Chemical Corps study used in court cases, increases found were:

 

Excessive hospitalization rate for mental disorders. These mental disorder diagnosis were accompanied by other findings of excess brain cancer, nervous system disease, and neurologically based excess accidental deaths.  Out of approximately 1000 men serving in the Chemical Corps, 894 were located for the study. During the study period from 1978 to 1988, 136 out of the 894 Chemical Corps veterans were treated as inpatients in the VA medical system. Mental disorders were the most common primary diagnosis among the 136 patients.  No statistical analysis of these findings was provided by the VA. (In the United Sates District Court for the Eastern District of New York case of Ivy versus – Diamond Shamrock Chemicals Company.)

 

Excess deaths from nervous system disease, as well as the excess deaths from Hodgkin's disease, leukemia, and
brain cancer were found. Deaths from nervous system diseases included two deaths (0.7 expected, SMR = 4.16) from amyotrophic lateral sclerosis and one from multiple sclerosis.  The authors discussed the fact that although these diseases were of unknown origin, "recent epidemiological studies suggests a possible association between motor neuron disease and occupational exposure to organic solvents."
(In the United Sates District Court for the Eastern District of New York case of Ivy versus – Diamond Shamrock Chemicals Company.)

 

It should also be noted that the Australians in a report of over 44,000 of their Vietnam Veterans expected 2 motor neuron disorders and found 128 over ten years ago.  Clearly a noted substantial increase over what the normal ratio of the population.   Some reports show an increase of over 600%.

 

Sampling flaws might be overlooked in a study conducted on a less important, less deserving research question, but it is simply not acceptable by the premier group of scientists in this country on behalf of the most deserving group of citizens in this country.

 

Recently Dr. Han Kang the Director of Veterans Affairs Environmental Epidemiology published in the American Journal of Industrial Medicine a report that conclusively demonstrated associations to Veterans with TCDD herbicide exposures and the following disorders:

 

Diabetes

Heart Disease

Hypertension

COPD all lung issues except cancers

Current health is poor

Current health limits the type and amount of work

 

All of these issues except Diabetes are not associated at present according to IOM and VA even with their own findings.  Veterans and their families from other studies have been saying the exact same thing for decades now.

 

Including in this study Dr. Kang found an association to Hepatitis to Military Service in Vietnam.  Once again Veterans and their widows have been saying this for decades.   Not from the studies but from the symptoms and findings of the studies one develops, which could only be a liver dysfunction > to a hepatic diagnosis.  Veterans Affairs has continually blamed this on the Veteran and not his service.

 

The government funded CDC studies have been accused of also playing politics with facts in this Veterans Issue with interference by not only the White House but also the Secretary of State.  (HR 101-672) {The Agent Orange Cover-up: A Case of Flawed Science and Political Manipulation. v, 43 pp. Report of the House Committee on Government Operations, August 9, 1990 (pp. 1-38) and dissenting views (pp. 39-43).  Y 1.1/8:101-672}

 

The Veterans Administration Committee on Environmental Hazards (VACEH) that operated from 1979 to 1991 which was replaced by “this committee” was less than honest and it is unclear as to what they were actually trying to do according to various toxicology experts and prestigious research scientists.  Comments were made that it was unclear as to what this committee was trying to do, demonstrated bias against the Veterans Community, and that nothing this committee had concluded should be used to determine anything; including health care or compensation benefits. (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.)

 

The IOM itself has made statements in medical issues that the possibility exists of such medical disorders being associated but the IOM does not know “how to apply this” to our Vietnam Veterans.

 

For instance, in “NEUROBEHAVIORAL DISORDERS” the IOM lists all the facts that show this could be an issue not only with 2,4,5-T but also with 2,4-D.  Then states, “considerable uncertainty remains about how to apply this information to the evaluation of potential health effects of herbicides or Dioxin exposure in Vietnam veterans.”  So by taking this stand the IOM is saying there is no proof of human neurotoxicity being associated with our exposures to both of these toxic chemicals with not only dioxins (plural) but also closely related furans.  Many scientists would disagree with this IOM stand and certainly, the ethics of research mandate that this very significant statement be clearly understood by those at the VA who should not have jumped to the conclusion that this study could possibly be the last word on the subject. At the least, further research into that separate issue should have been attempted.

 

Yet, in no case does the IOM indicate what data is needed to “not have” this “questionable” Veterans “application issue.” The unclear recommendation in itself, has cascaded into a whole variety of missteps by our government who (rather than try to understand the implication of not knowing how the data could be applied to individual veterans) chose to ignore the possibilities or negate the study flaws, the confusion over how to interpret data and proceed; and how to formulate just and fair research conclusions.

 

Vietnam Veterans, as well as their widows, with this lack of scientific integrity, depended on a very biased 40 year government history of not being forth coming and manipulating data in our issues. We are wondering if we will ever get a “fair assessment” of our health issues associated with exposures of many varieties of toxic chemicals that resulted in both ‘acute’ and ‘chronic’ conditions unrecognized by the VA as compensable. We believe that there are some very significant trends in veterans (and offspring) that have not been even considered for study because the IOM ignored these veterans as candidates for subject inclusion. We believe that there is a possible explanation for the wide variation of what is being reported by veterans who were never studied for exposure to chemical defoliants. Ranch Hand study participants were selected because of their exposure time while mixing and handling the chemicals. But these same participants (as crew members of fixed wing aircraft) did not experience the direct effects of living in the chemical fall out, drinking the water and not washing it off skin for days and weeks. They went back to base after every mission and took a shower and drank from base (hopefully untainted) water supplies, whereas combat troops (who report many other health issues and experiences) may have had a more significant and direct exposure. At any rate, the exclusion of veterans who were not part of Ranch Hand was not just a minor decision by the investigators. It produced a potentially fatal flaw in the data and then, by extension, the research conclusions.

 

This is especially true in the form of other birth defects and other cancers, as well as concerns of heart disease, vascular disease, neurological ailments, endocrine disturbances, and hematological difficulties. (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 - statements by Doctor Albanese, Principal Ranch Hand Scientist)

 

This would certainly also include immunotoxicity. This is of “major concern” since the EPA has indicated for “civilians of our nation,” that immunotoxicity requires a dioxin threshold 100 times less than that of any cancer. (EPA Dioxin Reassessments)

 

Many Veterans do not understand how the IOM cannot find immune system problems associated that so many Vietnam Veterans have in the form of autoimmune disorders that is not hereditary.  Considering studies have found B and T cell dysregulation with specific cytokine involvement in Interlukin-4, Interlukin-10, Interferon-gamma, and the ratio of Interlukin-4:Interferon-gamma is significantly lowered.  This also correlated to found issues in increases of IgE as well as significant decreases in IgG1 and IgG2.  (Immunotoxicological Effects of Agent Orange Exposure to the Vietnam War Korean Veterans, published in Industrial Health 2003, 41, 158-166.)

 

The decrease of IgG1 was also found significant in the German study of workers exposed to TCDD.  (Nubert R, Maskow L, Tribig G, Broding HC, Jacob-Muller U, Helge H, Neubert D, (2000) chlorinated dibenzo-p-dioxins and dibenzofurans and the human immune system : 3. Plasma immunoglobulins and cytokine workers with quantified moderately-increased body burden.  Life Science 66, 2123-42)

 

When looking and comparing a matrix of these found issues even our B & T cell cancers associated seemed to be clearly denoted.  This also clearly indicates immune system dysfunction in both Cellular Immunity as well as Humoral Immunity.

 

“Cellular immunity” - the ability to fight viruses and other intracellular pathogens, eliminate cancerous cells, and stimulate delayed-type hypersensitivity (DTH) skin reactions.

 

“Humoral immunity” creates up-regulated antibody production to fight extracellular organisms.

 

Considering that a reduction in IgG1 subset is not a standard medical care provider test.  This decrease becomes paramount when one looks at only the effects of decreased IgG1.  -  (While a doctor may look at the deltas or out of range of all immunoglobulins - a subset homeostasis test is not the norm.) (The nominal IgG may be within normal range but the IgG1 may be significantly lowered.)

 

Note:  IgG1 plays a significant role in Humoral Immune response with an IgG1 decrease leading to down regulation of antibody-mediated host resistance, enhancing infections and/or tumor progression.  (Jeffries R, Kumararatne DS (1990) Selective IgG subclass deficiency;  Quantification and clinical relevance. Clin Exp Immunol 81, 357-67)

 

Even more evident and quite serious when one looks at the fact that one of the functions of the cytokine Interferon - gamma is the "inhibited function of viral replication." 

 

Many Vietnam Veterans and their families do not understand how the IOM cannot conclude that the dioxin TCDD is an all site carcinogen and may be the very first manmade carcinogen with that notoriety.

 

Several studies have indicated that there is very little difference in "specific site related" and to "overall cancer site related."  (Short and Long Term Morbidity and Mortality in the population exposed to dioxin after the Seveso Accident; Industrial Health 2003, 41, 127-138.) (Dioxin:  Exposure-Response Analysis and Risk Assessment; Industrial Health 2003, 41, 175-180.)

 

When trying to determine if there is a linear relationship to the dioxin TCDD many studies have concluded for some medical issues there appears to be no such response and it could not be determined if such a response would be linear, step-linear, or logarithmic. (Short and Long Term Morbidity and Mortality in the population exposed to dioxin after the Seveso Accident; Industrial Health 2003, 41, 127-138.) (Dioxin:  Exposure-Response Analysis and Risk Assessment; Industrial Health 2003, 41, 175-180.)

 

Historically, studies have found these toxicants disturb the balance of between regulatory and effector T cells, which can lead to selective activation or suppression of T-cell subsets with production of distinct cytokines resulting in various immunopathologic states in humans.  Not even discussing the effects on the immune system of Macrophages and Monocytes which many scientists believe can also direct or impact immunity. 

 

This becomes even more evidentiary when you look at our associated cancers from the very same process of disturbance in B and/or T cell homeostasis as above that have already been associated.  In some cases over 17 years ago while the evidence for association was available decades before that.

 

Could or would the IOM explain how it is that a B and or T cell dysregulation will in all cases cause only the specific cancers the IOM has decreed it will and not some subset of smoldering cancer; or the many forms of autoimmune disorders that can be associated to the same causation process were the cell maturations to form a cancer or cancerous condition are delayed or stopped from whatever the reasons.

 

Logically would this lack of any other disorders associated except the specific site cancers the IOM has decreed associated at least in the overall conclude that somehow the IOM has determined:

None of this seems medically or scientifically logical to the Vietnam Veterans or their widows.

 


 

In that context, we would ask this committee the following: 


 

In that context, we would further ask this committee the following: 


  

SPECIFIC ISSUES

 

Since the IOM taking over for the VACEH in 1991 and has now become in essence our judge and jury, it is imperative that Veterans know exactly what your processes are, as well as your mandated “government constraints.”  Not only imperative but also if Veterans are to regard and comply with the outcomes of your findings,  we must know what we are being judged on, to what levels, and do those levels meet the “intent of congress” or even a real legal court system based on the constitution; not the VA court system. Can this committee from IOM findings stand up to international scrutiny regarding the entire Vietnam War Chemical Exposure issues? 


In that context the following questions are asked:

 

Is the government contract with the IOM constrained to primarily only the dioxin, TCDD?


If no - does the IOM consider the effects of the dioxin, TCDD with other commonly used chemicals, medications, the pesticide Malathion, or malaria pill Dapsone used in the commission of the war in Vietnam.  Alternatively the dioxin, TCDD with other toxic chemicals such as cacodylic acid, nitrosamines, picloram, hexachlorobenzene and other lesser known dioxins and closely related furans that were noted as being in Agent White. 


Will the IOM update a Review of Literature (ROL). Will this ROL include advisory statements published by the EPA, OSHA, the FDA, and the chemical contractors themselves regarding said chemicals published and easily accessible online---warnings about how these toxic chemicals are to be stored, mixed, used and first aid measures after an exposure?


The DoD owed a duty to make sure that chemicals were used according to manufacturer’s guidelines and not at some application rate of six to twenty five times the civilian population usage. 

 

Does the IOM take this increase of dosage rate into consideration?


On the many firebases such as along the DMZ that were subjected to Agents Orange, White, and Blue with many overlapping spray areas.  With the half life of some these chemicals in a moist environment documented as in years.

 

Does the IOM consider the exposures in series or concurrent.  If considered concurrent does the IOM also take this multiple toxic chemical ingestion into consideration.


 

Since all Vietnam Service Veterans are presumed to have been exposed to these chemicals, and the effects of the chemicals are published, isn’t further study redundant? The IOM  cannot reconstruct the war in Vietnam or place human beings into harm’s way for the purpose of further study.  Isn’t it logical to acknowledge these published known conditions that are associated with toxic exposure to the dioxin TCDD, arsenic, and all the other toxic chemicals, etc. Then instruct the VA that it would be prudent to assess for those conditions in any Vietnam Veteran or his or her medical record in the preceding years, treat them for those conditions and compensate them if they are unable to work due to those conditions? 


 

The IOM government contracts for four levels of associations or pronouncements to be published every two years.

 

Do you have established and published within your committee the following: 

Veterans are “assuming” that this process is not "purely subjective" to the individual scientists beliefs or disbeliefs as what the dioxin, TCDD can or cannot do to the body.  

When comparing Vietnam Veterans to NON-Vietnam Veterans in a documented and published medical study exactly WHO is considered a Vietnam Service Veteran and who would comprise the control subjects?   

If any of this is documented, would you be able to supply a copy of all pertinent protocols and government mandated constraints.

 

If not - why not?  


 

DISCRETE ISSUES

 

Given the following set of circumstances concerning at least two epidemiological studies, is this good enough for consideration to recommend as presumptively associated by this IOM committee? (Impact of Agent Orange Exposure among Korean Vietnam Veterans, published in Industrial Health 2003, 41, 149-157.) (Immunotoxicological Effects of Agent Orange Exposure to the Vietnam War Korean Veterans, published in Industrial Health 2003, 41, 158-166.)

 

To verify the differences and the facts found the study used secondary specialists again as blind random samples of X-ray films and NCV recordings. 


The results of “Disorder X” was:  

The second study the pronouncement was made as follows: 

 

Is this not good enough for the IOM to recommend associations as presumptive for “Disorder X?”

 

If NOT – WHY NOT?  What are the Veterans missing here that is mandated by either our government or your own internal procedures.

 


In addition to the above:

 

The Ranch Hand scientists reported the following:  


 

In observations to date – Air Force Report: 


 More evidentiary findings: 

Perhaps the IOM membership here could explain how it is “Disorder X” is not considered “at least as likely as not” associated to our wartime exposures to these toxic chemicals of “weapons of mass destruction.”

 

We have p-values of difference, p-values of association to Agent Orange, 2.39 Odds Ratio, dioxin assessments showing a connection in our own government studies with an adverse relationship; also found associated to dioxin levels, we have empirical data showing the wide spread manifestations among our Veterans population that served in Vietnam or were exposed to the toxic chemicals elsewhere.

 

How can this “Disorder X” not be associated by IOM?

 

In your medical opinion, with all the findings listed, how can Veterans Affairs continually deny the associations based on the requirements described by  “The Agent Orange Act of 1991, Public Law 102-4,105 Stat. 11?

 

Alternatively, is this IOM Agent Orange Committee at present, as the Presidents/DOD/VA we have had all along, ASKING for Vietnam Veterans and their families to prove "what cannot be proven?"

 


 

Regarding Birth Defects: 

 

It should be noted that as early as 1977 information about Agent Orange’s potential for genetic damage was known to the VA. For example, a "NOT FOR RELEASE" VA document expressly noted Agent Orange’s "high toxicity" and "its effect on newborn, deformed children —— similar to the thalidomide situation." (See L. Casten, Patterns of Secrecy note 73 supra at Department of Veteran Affairs p.4.)

 

Similarly, in March of 1980, Senator Tom Daschle and Rep. David Bonior received an anonymous memorandum written on VA stationery, which stated:

 

…chemical agents 2,4,5-T and 2,4-D commonly known as Agent Orange; and Agent Blue, are mutagenic and teratogenic. This means they intercept the genetic DNA message processed to an unborn fetus, thereby resulting in deformed children being born. Therefore, the veteran would appear to have no ill effects from the exposure but he would produce deformed children due to this breakage in his genetic chain.... . .Agent Orange is 150,000 times more toxic than organic arsenic. (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.)

 

Secretary Principi awarded additional “neural tube birth defects,” other than spina bifida on the maternal side not because of dioxins or toxic chemical exposures but due to “service in Vietnam alone.”  This seems dubious at best since reported in 2000 a comparison of the study in female veterans and male veterans the results were almost identical.  Yet, because the male Vietnam Veterans did not meet "the standard of a linear increase with dioxin," the fact of that difference has not been further pursued.  (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 - statements by Doctor Albanese, Principal Ranch Hand Scientist)

 

The government requirements are all of a sudden different for maternal side birth defects; more than likely based on numbers of victims, not scientific facts.

 

{Definition - Neural Tube Defect

 

A neural tube defect (NTD) is a birth defect that occurs when the spine, the brain, or the bone and skin that protect them do not develop properly. The most common type of neural tube defect is spina bifida, in which the spinal cord or spinal nerves may bulge out through an opening in the bones of the spine.

 

The neural tube is the part of a developing fetus that grows into the spinal cord and brain. Normally, the bones of the skull and spine grow around the brain and spinal cord, and then skin covers the bones, creating the neural tube. A neural tube defect occurs when this process doesn't happen normally.

 

Anencephaly is the second most common type of neural tube defect. In anencephaly, the infant is born with only a partially formed brain and spinal cord. This condition is always fatal.)

 

The current position of “spina bifida only” on the paternal side would conclude that of all the neural tube birth defects defined by medicine; only one birth defect can be created by the paternal side exposures of these teratogens. 

 

What proof does the IOM have that a teratogen can be the direct cause of “only one birth defect” in a classification of birth defects?  Considering the statements above that the study results between female and male Vietnam Veterans were almost identical; would not this conclusion be medically impossible.

 

As below some actual practicing, doctors are starting to question the facts put forth by the VA and the IOM in our toxic chemicals (plural) legacy.

 

From a BVA case:


According to the reviewing neurologist, Dr. Genet D'Arcy,


“As a neurologist, I would have to state that it would be my opinion that neural tube defects felt to be “etiologically related to a teratogen” should "all be included" and not just one, as that “does not make embryologic logical sense.”  As Dandy Walker is, by most authors felt to be a neural tube defect, it would be the opinion of this examiner that if the child carries the diagnosis that he does in fact have a neural tube defect and therefore has an analogous disorder to spina bifida. ...Dandy-Walker is, in the opinion of this examiner, a neural tube defect and therefore, it is as likely as not that he is warranted for compensation on the qualification as a diagnosis related to spina bifida and presumptive Agent Orange exposure on the part of the father while serving in Vietnam.”

 

In this opinion, other neurologic conditions including lissencephaly, microgyria and agenesis of the corpus callosum are also mentioned as related to Dandy Walker cysts and thus within “the spectrum of neural tube defects.”

 
In another BVA case, Michele Jones versus Prinicipi (00-669), a paralyzed Vietnam veteran won compensation for his daughter who was born with encephalocele, also a neural tube defect.

 

It should also be noted that the Seveso, Italy dioxin study pointed out altered sex ratio with parents that where both heavily exposed in 1976.  This study continued until 1996 with the concluding statements; paternal blood concentrations emerged as the most important predicator of lowered sex ratio at birth.  This study clearly demonstrating a “primary paternal effect in birth issues” from dioxin exposure. 

Obviously, we had seen where the IOM is mandated to review “peer reviewed” articles only.

 

Peer reviewed articles are crafted for publication based on what the study protocols were designed to find and prove.  Not the data that was found that did not meet that level of proof as demanded by the protocols.  These protocols can be as stringent to cell level or only showing a trend in disorders found.  

 

You could write books about data found in these studies and not reported on just the data that was found and not brought forward in the Ranch Hand studies where the protocols change as the data collected becomes more damaging.

 

As you can see, Vietnam Veterans are wondering where this committee stands as to levels of associations and proof required.

 


 

The other question Vietnam Veterans would ask of this committee. 

 

Does this committee feel like it is protected against legal actions of not meeting the “intent of the congress” and the Dioxin Standards Act of 1984 by being a contracted government agency and under the protective umbrella of the Feres Doctrine?  

 

As medical scientists, bound by the duty of "do no harm" in your work as researchers, can you attest that you have and will do justice for Vietnam Veterans who are waiting, evermore impatiently for answers that make sense to them?

 


 

Thank you very much for your time today.

 

Let us hope we can all work together to get a better understanding of what the issues are at hand and how to solve these issues before all our Vietnam Veterans are dead.  Died while waiting for answers and help from our own government that created this National Disaster.

 

Charles Kelley

Snellville, Georgia

Veteran DMZ Vietnam 67-68