Presumptive Disorders

1. Presumptive Disorders By Charles W. Kelley

2. For over 40 years, there has been a history of political interference in government-sponsored studies associated with Agent Orange and other militarized herbicides in Agents White and Blue.  In fact, there appears to have been a systematic effort to suppress critical data or alter results of scientific studies.  Faulty conclusions, flawed methodology, and noticeable bias are not just an isolated problem.  Other governmental agencies responsible for specifically analyzing and studying the effects of exposure to Agent Orange strongly hints at a discernible pattern to deny compensation to Vietnam Veterans for disabilities and death associated with exposure to the dioxin, TCDD contained in Agent Orange.

3. CHANGES TO RANCH HAND FINDINGS Wherein the scientists not wanting to duplicate their review work suggested they not review what they had found in draft form until the Air Force had completed all the changes to those findings. When the lead scientists said, “We do not want to say, “CHANGED.” The inquiring scientists then said, “OK how about airbrushed?” Laughter broke out in the room!

4. WHITE HOUSE BUREAU OF THE BUDGET MEMO The White House Bureau of the Budget put out a memo to 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: • The cost of supporting the Veterans. B) The court liability to which corporations would be exposed.

5. DR. RONALD TREWYN, RANCH HAND SCIENTIST “…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 wartime service in Vietnam.” “And it doesn't take a scientist to figure that out.  This is common sense now, a lot of it.  It's like now wait a minute.  This just does not pass the smell test or the common sense test.”

6. DR. JOEL MICHALEK, RANCH HAND SCIENTIST • “It spoils everything, 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.”

7. The government entity responsible for this monumental scientific screw-up denied Veterans and widows for at least a quarter century. Michael Stoto, AO committee chairman and a professor at Georgetown University, "when it shows a significant finding and it seems to have been suppressed, that doesn't add credit to the study.”  Col. Karen Fox told the civilian AO advisory committee “The Air Force has no plans to publish the new cancer findings in any Air Force report or scientific journal. “Fox said the Air Force instructed the scientist who conducted the analysis to destroy the data.”

8. WHAT PERCENTAGE OF CERTAINTY IS NEEDED TO FIND “PRESUPTIVE ASSOCIATIONS Congressman Shays: “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 have died early or you will have died in your old age in pain, but you will not get help from the Federal Government. “That is the honest answer that I have to give people, if in fact we have to wait until we have 99 percent certainty…. “But it is an eye-opener to me because my view is that I do not want to wait until you have 99--maybe I would like to be 70 percent certain and then I am willing to go to my taxpayers and say you are going to pay more to help veterans we sent to war.”

9. THE AREAS OF MOST “SERIOUS CONCERNS” • The study was crafting for publication only. • The study was being used as world gold standard, which is incorrect. • The use of command influence.  Including mandated ratio changes by using the name of the Surgeon General. • Protocol violations and the changing of established protocols and these were considered quite serious. • The changing of the concluding medical statements the scientists found and reported; after they had been cleared for publication. • Scientists did not consider themselves intellectually free. • Scientific fraud was being committed.

10. “SERIOUS CONCERNS” CONT’D • 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. • 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 testified 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.  In his opinion, as a doctor, these men were ill.  These medical areas were in cancers, birth defects, heart disease, vascular disease, neurological ailments, endocrine disturbances, and hematological difficulties. • Several scientists and Congressmen indicated that they wanted to see other data that had not been associated with the VA. • Cohort selection was questionable. 

11. PATTING MYSELF ON THE BACK In my review of the transcripts, I spotted these fatal flaws and contacted the IOM in 2003 so stating that the assumptions of cohort exposures was totally erroneous and flawed.  Comparing cohorts that were both exposed and both developing cancers and other diseases and disorders and to then say, we found no or little difference in the cohorts is nothing but scientific misconduct. IOM told me everything was on the up and up.  Yet, here we have four years later, after my book on this subject was published, the lead DoD scientists and a two time member of the Agent Orange Advisory Committee agree with statements that parallel what I had concluded in my book.

12. MEDICAL ISSUES FOUND AT 50% INCREASE OR GREATER NOT BROUGHT FORWARD Studies have shown there is no linear dose response to the dioxin, TCDD in certain medical disorders and at least a 15-year lag-time should be considered.  In Attachment 5, you will find in a quantitative analysis of four exposure groups totaling 3,538 workers so stating that a threshold model did not fit the mathematical models and therefore indicates there is no threshold of exposure below which there is no cancer risk.  This study was based on 5 ppt.  Ranch Hand cohorts were found to have 65 ppt 32 years after exposures.  This mathematical study also concluded there is little difference of Standardized Mortality Ratio (SMR) between a single cancer site and all cancer sites.  This was not only a mathematical finding but also the biological issues of dioxin effects on cell receptors, which are throughout the entire body.

13. VA’S TOO STRINGENT POLICIES 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 causal relationship.  – See Nehmer v. U.S. Veterans Admin.,712 F. Supp. 1404, 1408. (N.D. Cal. (1989).

14. "increased risk of incidence?" veterans DEFINITION: A measure of association between exposures and the risk of selected diseases is called the Odds Ratio or Risk Ratio.  Odds Ratios and Risk Ratios depending on a few subjective interpretations should approximate each other or close.  Odds Ratios assume some factors that Risk Ratios do not.  These are ultimately referred to as the “incidence odds ratio.”  Obviously, you cannot have an “increased incidence odds ratios” without having “an increased risk of incidence.”

15. "significant correlation?"veterans DEFINITION: The more data points you have the more significant your correlation in the statistical sense.  This means it is unlikely to be due to chance alone. We have studies that demonstrate Veterans who sprayed in Vietnam and those Veterans that sprayed elsewhere.  Both show increased Odds Ratios of certain disorders and diseases. We have studies that demonstrate the difference between Vietnam Veterans and Non-Vietnam Veterans that find increased Odds Ratios to the same disorders and diseases.

16. Disorder X

17. Findings of the Veterans Administration Committee on Environmental Hazards (VACEH) On May 23, 1991, the Veterans' Advisory Committee on Environmental Hazards (VACEH) considered the relationship betweenexposure to dioxin and the development of this condition.  The Committee concluded that there is a "significant statistical association" between “Disorder X” AND exposure to dioxin.

18. FINDINGS OF THOSE THAT WERE ASSOCIATED TO SPRAYING HERBICIDES IN VIETNAM BY THE RANCH HAND STUDY • The Air Force Ranch Hand Study in the scientific transcripts stated a found dioxin response to "Disorder X.”  (16) • “Data showed a significant increase in the index of  “Disorder X”.  Another run through the data showed it correlated significantly with dioxin.”  (16) • “A significant and adverse relationship between “Disorder X” and dioxin body burden was found.”  (17) • One of the leaders of the Ranch Hands studies, Dr. Michalek, in an announcement "Serum dioxin and “Disorder X” in veterans of Operation Ranch Hand" stated:  "... we consistently found a statistically significant increased risk of all indices of “Disorder X”among Ranch Hand veterans…”  (18)

19. SEVESO, ITALY DIOXIN ACCIDENT DISASTER Seveso, Italy Residents in the 15-year mortality/morbidity dioxin only accident study found a “three-fold increase” to five-fold increase depending on age in Disorder X . (21)

20. 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 Disorder X at a p-value of 0.039.  The study also found a p-value of difference between Vietnam Veterans and non-Vietnam Veterans with Disorder X of a p-value of difference of 0.0042.An adjusted odds ratio (OR) was found of 2.39.  (19)  • In a second Korean impact study evaluating the immune system the statement was made: “Based on the results of two epidemiological studies, Disorder X is the most prevalent diseasefollowed by Lung Cancer, Beurger’s Disease (peripheral vascular), Larynx Cancer, non-Hodgkin’s Lymphoma, and Chloracne associated with Agent Orange Exposures”.

21. ADDITIONAL INFORMATION “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)

22. INTERNATIONAL AGENCY FOR RESEARCH ON CANCER • “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 noted that Disorder X system damage was also found in the same six dioxin-exposed populations, including Disorder X with 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 Disorder X and personality changes (IARC, 1986).  (13)

23. TESTING THAT NO LONGER APPLIES • In reviewing the Ranch Hand Study transcripts, I found in 37% of the Ranch Hand Study cohorts diagnosed with confirmed diabetes were not testing properly for the A1C test. • The A1C test is used as a doctor’s way to find out if you have a possible diabetes problem that may not occur in the office at that time. Possibly a medical complaint that happen several times prior to coming to the doctor’s office. • With 37% of the Veterans study group not testing properly then it would be logical to conclude that number or close would hold true for 4.2 million exposed Veterans. • How do I know? I fell into this 37% group whose A1C test did not indicate my diabetic problem. • In these cases, the more sensitivity oral glucose tolerance test is required which is not standard.

24. Issues with the Department of Veterans Affairs

25. CONGRESS MANDATED BENEFIT OF THE DOUBT(Public Law 98-542 Sec 2 Para 13) “It has always been the policy of the Veterans Administration and is the policy of the United States, with respect to individual claims for service connection of diseases and disabilities, that when, after consideration of all the evidence and material of record, there is an approximate balance of positive and negative evidence regarding the merits of an issue material to the determination of a claim, the “benefit of the doubt”in resolving each such issue shall be given to the claimant.”

26. BENEFIT OF THE DOUBT Here is an example of this non-compliance practice documented below which is used over and over again as a way to deny Veterans: In BVA Citation Nr: 0317458, Decision Date: 07/24/03 wherein everyone at the BVA hearing agreed the Marines Peripheral Neuropathy was at least with a 50/50 chance that dioxin was the causation of this crippling nerve disorder.  The BVA then said that the Marine’s case is denied based on statements made by the Secretary of the Department of Veterans Affairs.  There was no Benefit of the Doubt given.

27. MY BVA AFTER FIVE YEARS OF WAITING I went through all the processes thinking at some time I would get a chance to present my evidence related to my disorders with the study data I had accumulated and the chronology of medical issues after returning from Vietnam.  I thought as any citizen, I would ultimately be allowed to prove my points in a legal setting.  I was not allowed to present my case for the official transcripts and I was not allowed to present an office-shopping cart of data and analysis I had found that directly related to my case.  I was not allowed to make a 20-minute presentation on what the VA had denied and how my evidence proved the VA wrong.  If there are 10 Veterans in the nation other than myself that could have presented a well-grounded case based on the government’s data itself, I would be surprised.  Yet, I was denied what I would consider a constitutional right.  So I am right back in the VA hamster wheel denied that right to present a sound, “evidence based case” against a run away federal agency.

28. KOREAN DMZ VETERANS Korean DMZ Veteran David Hill of Tennessee was diagnosed with lung cancer as well as chronic lymphocytic leukemia (CLL) both of which are presently found “Presumptive Disorders” to Agent Orange.  At time of discharge and documented on his military medical records he was diagnosed with pustular acne, a hallmark of dioxin exposures in some individuals.  Veteran Hill was given approximately 18 months to live about 8 months ago.  VA denied him compensation because he was outside the DoD/VA inclusive dates of service along the DMZ by two months.  He then asked what about the half-life of dioxin. Their reply was the half-life study would have had to been done in Korea. Veteran Hill was physically stationed on the DMZ from about late 11/68 or early 12/68 till 05/70.  He arrived on station in Oct of 68 and prior to being assigned to the DMZ made courier runs by wheeled vehicle and sometimes by helicopter to the DMZ.

29. EPA FACT HALF-LIFE SHEET ON THE DIOXIN, TCDD THAT SPECIFIES THE FOLLOWING • On top of the soil, half-life of one to three years. • Within the soil, half-life of eight years. • In water with absorption to sediment, the half-life can be over 50 years. • Dioxin is resistant to biodegradation. • Dixon is resistant to significant photo degradation. • Dioxin has very low water solubility.

30. IOM REINTRODUCES CAUSATION REQUIREMENTS (this is wrong) Are We Veterans now back to proving Causation Requirements Again? VA is back to its old tricks of upping the requirements once again as the pendulum swings to our side as data is found.  IOM in its presentation of “Presumptive Disorders” at the Veterans’ Disability Benefits Commission once again has inserted the word “causation” in the top levels of Presumptive Associations. 1.  Sufficient:  the evidence is sufficient to conclude that a “causal” relationship exists. 2.  Equipoise and above:  the evidence is sufficient to conclude that a “causal” relationship is at least as likely as not, but not sufficient to conclude that a “causal” relationship exists.

31. BIOLOGICAL ASSOCIATION FOUND OR PLAUSIBLE Example 1:  In a proven biological damaging process associated to Herbicides such as Vasculopathy Disease/Disorder.  Then all disorders/diseases that are normally found associated with this damaged process would be biologically associated. Vasculopathy process damage in me could be three other issues in someone else; all of it associated to the damaged process.

32. BIOLOGICAL ASSOCIATION FOUND OR PLAUSIBLE Example 2:  In a proven B and/or T cell dysregulation process associated to Herbicides, the outcome in worst-case cell maturation overtime would be cancers.  What I develop and what three other fellows develop depends on our separate DNA issues and many many different issues.  It would also be biologically plausible that many of us would not hit the worst-case cell maturation of cancer but the cell maturation process could be arrested creating an autoimmune disorder because of the DNA differences in humans. That is not to say that eventually the autoimmune disorder would not or could not complete cell maturation decades later.

33. PRESUMPTIVE DISORDERS My Battalion members are diagnosed with presumptive cancers and die within a six-month period or shortly after. Cancer is not some poof you have a cancer. By the time, you find out in many cases it is too late. Does the VA not have the where-with-all and personnel to approve an automatic claim that should take weeks that may have let these men die in some comfort? Yet, VA has enough personnel and where-with-all to call, the widows of these brave men and tell them what their options are within two days of the death.

34. PRESUMPTIVE DISORDERS Presently one of my 2/94th Battalion Members, Gary Henton of C Battery is still waiting on VA financial help from an associated lung cancer diagnosed in a VA hospital by VA doctors in May of this year. Veteran Henton and his wife Karen need financial help now in fighting this government caused cancer. They need to focus all their attention on beating the cancer not what VA is going to do next to stall the claim until he is dead.

35. VA PERFORMANCE • Where is the incentive for VA to perform or approve anything at all in a timely manner?  • As citizens and taxpayers, are we no longer entitled to some level of federal agency performance and transparency of what it is VA is doing and more importantly for whom?

36. HOW MANY HAVE DIED WAITING? Knight Ridder news reported after suing Veteran Affairs for the data and I quote: March 06, 2005:”Knight Ridder news may be onto one of the biggest stories of the year: 13,000 veterans needlessly died awaiting appeals on VA benefit payments, with a net savings of untold millions for VA.” 13,000 is probably a gross understatement. (this does not include those Veterans who have lost everything they worked a life time for while waiting)

37. MY RECOMMENDATION Chairmen Filner should set up meetings between Veterans such as Mike Eckstein, Paul Sutton and myself and some leading scientists. These meetings would be to discuss the data we Veterans have that prove disorders as associated and/or prove "it is at least as likely as not" they are associated to herbicide exposures.  Once conclusions have been reported the Chairman and Congress could decide how to respond.

38. Recommend meetings and presumptive Issue subjects (Not in any order) • Neuropsychological issues VS PTSD • All cancer sites • NEUROLOGICAL issues INCLUDING PERIPHERAL NEUROPATHY • Immune system issues • Vascular • Cardiovascular • Endocrine issues • Hepatic issues • HEMATOLOGICAL issues • Paternal associated birth defects • SKELETAL issues • PULMONARY function issues

39. SOME SCIENTISTS WE WOULD RECOMMEND Dr. Linda Birnbaum Dr. Mary Paxton Dr. Arnold Schecter Dr. Linda Schwartz Dr. Jeanne Stellman Dr. Ron Trewyn

40. THREE DATA POINTS Presumptive findings require the verification of three data points. • Did the Veteran serve in Vietnam? • Is there a valid diagnosis? • Is that diagnosis on the list of Presumptive Disorders?

41. Ways to reduce backlog of claims • Already proven presumptive association claims for Veterans that are diagnosed with Stage IV or above cancers no more than 30 days for approval and money in the bank using electronic transfer. • Already proven presumptive association claims for Veterans that are diagnosed below Stage IV cancers no more than 60 days for approval and money in the bank using electronic transfer. • Already proven presumptive association claims for Veterans that are diagnosed for disorders, other than a cancer, that is automatic such as diabetes (one example only) - no more than 90 days for approval and money in the bank using electronic transfer.

42. Ways to reduce backlog of claims cont’d • Identifying similar claims for what should be presumptive disorders in the BVA process that have already been approved after going through all the litigation points and BVA remands back to BVA appeals and on and on. Once identified these disorders and similar cases with approvals can be identified as such and given to all raters and decisions makers as an addendum to pronounce an award. • The continuing process should be to continue to work on what is automatically presumptive to either herbicides or conditions in Gulf War, etc. Then move up those identified to the higher categories above. • Any process errors, if there were errors, would then be on the side of the Veteran.

43. Attachments SEE ATTACHMENT 1 for a summary and history of Government interference, misstated facts, faulty published redacted reports, use of command influence, protocol violations, etc. SEE ATTACHMENT 2for findings of Hepatic issues such as Hepatitis associated to “Service in Vietnam”and other findings of associations to the dioxin, TCDD in found significant correlation of adjusted odds ratios of:  Diabetes, Heart disease, hypertension, all respiratory problems minus malignant cancers, all cancers minus non-melanoma skin cancers, current health is poor, health limits kind and amount of work the veteran can accomplish.  (Dr. Han Kang Director, Environmental Epidemiology, Department of Veterans Affairs) SEE ATTACHMENT 3 for media Reports of the fatally flawed Ranch Hand Study touted as our government’s PIVOTAL dioxin, TCDD study, used as a gold standard to deny “presumptive associations.”

44. Attachments SEE ATTACHMENT 4 for transcripts of Congressional oversight committee on ranch hand and the issues found and not addressed. SEE ATTACHMENT 5for Dioxin: Exposure-response analyses and risk assessment. SEE ATTACHMENT 6for my 112 page challenge with data to the President, Congress, and the Department of Veterans Affairs that Disorder X is found as a presumptive associated disorder to not only agent orange but also other toxic chemicals to which veterans were exposed.  SEE ATTACHMENT 7 for findings of remands sitting and not being worked and denials based on no records. SEE ATTACHMENT 8 for EPA Fact sheet on the dioxin, TCDD and Environmental half-life. SEE ATTACHMENT 9for my 37 page challenge with data to the IOM and the Veterans Disability Benefits Commission on the using of the wording "causation." SEE ATTACHMENT 10for Blue Water Navy Facts on morbidity