It is clear that some who criticize the RAC and its reports have clearly either not read the 2008 or 2014 RAC reports or failed to understand them.
First, I'm not sure how anyone would ever measure quality by number of pages, an utterly bizarre measure for success or failure. That said, the new report is much shorter for two important reasons.
We ill Gulf War veterans must learn to see the difference between those who are actually helping us, and those with mere words that might sound good but are not backed up with actions. And we must learn not to attack our true and sincere friends lest we alienate them and find ourselves all alone.
And, we should all read the new Gulf War Illness CDMRP program booklet, because without a doubt it is this unique treatment-focused program that is providing us with the best hope for uncovering effective treatments for Gulf War Illness.
Finally, for those interested in these issues, next read the RAC 2008 and 2014 reports yourself, and judge them... for yourself. Because this is precisely what VA staff who fear the RAC and us Gulf War veterans do not want you to do.
First, the 2008 report covered research from 1992 to 2008 - 16 years. The current 2014 report covers only five years.
Second, it is shorter because the 2008 report included thirty pages reviewing the effectiveness of federal Gulf War research programs. This section was included because, as stated at the beginning of that section: "In addition to reviewing scientific studies and government reports, the Committee is charged with reviewing federal research programs established to address the health consequences of the 1991 Gulf War." Check the section out at pages 289-309 at http://www1.va.gov/RAC-GWVI/docs/Committee_Documents/GWIandHealthofGWVeterans_RAC-GWVIReport_2008.pdf The section discusses the amount of funding reported as Gulf War research from 1994 to 2007, how "studies identified as Gulf War research have little relevance to health problems resulting from Gulf War service", the "excess emphasis on studies of stress and psychiatric illness", etc. (pages 289-309)
There was going to be a section like that in the current report. But in May last year, VA removed from the RAC charter the charge to assess the effectiveness of federal research programs. So no similar section was included in the new report. What might have been in that section can be seen in Chairman Jim Binns' testimony to the House Veterans Affairs Committee oversight and investigations subcommittee on March 25. Click on "Appendix B" at the end of the testimony. http://veterans.house.gov/witness-testimony/mr-james-h-binns
What you will find is that:
1) Reported VA Gulf War research spending declined from $21.6 million in fiscal year 2008 to $6.7 million in fiscal year 2012;
2) Of that amount, only about 60% was actually specific to Gulf War veterans; and
3) In the past two years, VA staff has launched a broad effort to revive the old party line that Gulf War illness is just what happens after every war, all in your head.
But none of that made it into the report this time. It's obvious that it's because VA doesn't want an independent RAC pointing out that kind of information that VA has moved to bring the RAC under VA control.
For the current report, a deliberate decision was made to use tables to summarize studies in a way that's easy to compare at a glance, rather than longer narratives for each study.
It's obvious, too, that the uniformed postings are just more VA-influenced spin to try take the focus off VA. VA's new appointee to the RAC pulled the same stunt at the RAC meeting this week, claiming all sorts of things were missing from the report when in fact, these things *are* in the report. See the memo below that was handed out at the meeting that debunks these flawed and outright false allegations.
And, it is true only a handful of the 57 CDMRP studies are finished yet, so they aren't published and reported. Just a sampling of the pending studies were listed, but their description is influential in demonstrating how dramatically the kinds Gulf War Illness research being conducted has shifted due to the CDMRP.
The RAC also contributes a lot of output and recommendations besides its major reports. As one major example, the Gulf War Research strategic research plan was largely written by RAC members.
Ten members of the RAC (including myself), and its associate scientific director, served unpaid on the eight working groups that prepared the plan, including five who served on two groups, and four who served as the group leader (convenor). Then, inexplicably, the plan was gutted by VA staff, who went to great lengths to even remove the term "Gulf War illness" *everywhere* it appeared.
VA has had this comprehensive, consensus plan aimed at solving GWI -- no small feat to achieve -- sitting in their hands but has yet to even begin implementing it.
VA has had this comprehensive, consensus plan aimed at solving GWI -- no small feat to achieve -- sitting in their hands but has yet to even begin implementing it.
The sad thing is that in the past two years so much of the RAc's efforts have been taken up with pointing out what VA is doing to undermine research. Check out the RAC's June 2012 findings and recommendations: http://www1.va.gov/RAC-GWVI/docs/Committee_Documents/CommitteeDocJune2012.pdf
Among the inappropriate allegations is regarding GERD, a condition with which I am intimately familiar, having had total failure of my lower esophageal sphincter (LES), resulting in regurgitation of stomach bile that even further exacerbated my already damaged lungs until following reconstructive surgery. The author of those misguided allegations apparently fails to understand that GERD may be diagnosed based on symptoms alone. According to the medical literature, there is no current gold standard for diagnosis of GERD; previously, the gold standard was 24-hour pH monitoring. For more on the current gold standard for GERD diagnosis, see R. Tutian 2006; DeVault 2005; Liakakos 2009, Nwokediuko 2012, and many more. An endoscopy may be called for in order to determine esophageal erosion, esophageal inflammation, Barrett's esophagus, and complications of GERD. Endoscopy is not the current gold standard nor sole standard for GERD diagnosis, and indeed, in Non-Erosive Reflux Disease (NERD), one of two major forms (phenotypes) of GERD, may not even be able to detect GERD. Yet, that author demands the RAC incorporate endoscopy as his sole recommendation on GERD diagnosis, even though this is not appropriate.
Furthermore, the RAC report (and the referenced January 2012 Gulf War Research Strategic Plan) calls for comprehensive monitoring of Gulf War veterans' symptoms and health, which VA continues to fail to do. Were VA to do so, there would likely be a myriad of presumptive conditions for Gulf War (and other) veterans, which is likely the reason why Benefits Undersecretary Allison Hickey's secret agenda against Gulf War illness and Gulf War veterans' claims is so relevant to this discussion.
I should add that I'm also intimately familiar with GERD myself, having finally had a 24-hour pH monitoring test **outside the VA**, because VA caregivers refused to do anything other for my GERD than prescribe ineffective palliative medications and tell me to "elevate my bed mattress", failing to recognize that I was having symptoms day and night, supine, seating, standing, and walking. The surgeon who performed my Nissen Fundoplication esophageal reconstructive surgery -- a skilled lung transplant surgeon -- told me with great and sincere concern that it was evident that the acid regurgitation was severe and that it had put me at grave risk for a specific form of lung cancer common in GERD.
VA's failures not just of medical research, but of basic health care, are a recurring source of serious concern for me and for the countless hundreds of thousands of ill Gulf War veterans who VA fails on a daily basis, including in Phoenix, in Madison, Wis. where I was denied necessary health care but thankfully was able to obtain outside the VA (something no veteran should ever have to do), and virtually everywhere around the United States. Beyond the VA's failures to us Gulf War veterans who have what is likely neurologically induced LES-failure GERD that puts us at serious risk of other conditions, little irritates me more than this case of someone pushing "solutions" on GERD who clearly neither understands the science nor the medical care involved with GWI-related GERD. For more on cancer and GERD, see El-Serag 2001 and more. For more on esophageal cancer in GERD, see Chai 2012 and more.
In another example of a highly flawed "recommendation", the argument is made that these highly specific (down to individual research institutions) recommendations "must" be made so that the VA Secretary can request adequate funding from Congress. What the author fails to understand is that Congress provides a very broad line item for medical research and it is up to VA to decide how to spend it. For FY15, the Administration's budget line item request for VA's prosthetics and medical research is $588,922,000 (VA FY15 Budget Request, p. 6). VA doesn't need Congressional authorization to conduct studies on GERD, on prevalence of disease in populations of veterans, on MS, or on much of anything else. VA has a vast research budget and could and should be conducting this sort of research now, a fact that the RAC has made eminently clear in its major reports and recommendations in between major reports.
In recent years, VA staff have without proper oversight somehow seen fit to cut Gulf War research funding from more than $25 million per year down to just $4.86 million... and now tout that they have "increased" Gulf War research funding to just over $7 million as somehow a wonderful thing rather than the actuality, that these very low numbers are a continuation of the very serious cuts they have made to Gulf War research. For people who pay attention to and at RAC meetings, VA research staff have repeatedly made it clear that they currently have authority to expend $15 million on Gulf War research. This week, VA staff stated that if they reach $15 million, they have been told to then take it to $20 million. So, it is very clear that VA research staff have all the authority they need to expend funds on Gulf War research from within the very broad VA research funding line item.
Among the inappropriate allegations is regarding GERD, a condition with which I am intimately familiar, having had total failure of my lower esophageal sphincter (LES), resulting in regurgitation of stomach bile that even further exacerbated my already damaged lungs until following reconstructive surgery. The author of those misguided allegations apparently fails to understand that GERD may be diagnosed based on symptoms alone. According to the medical literature, there is no current gold standard for diagnosis of GERD; previously, the gold standard was 24-hour pH monitoring. For more on the current gold standard for GERD diagnosis, see R. Tutian 2006; DeVault 2005; Liakakos 2009, Nwokediuko 2012, and many more. An endoscopy may be called for in order to determine esophageal erosion, esophageal inflammation, Barrett's esophagus, and complications of GERD. Endoscopy is not the current gold standard nor sole standard for GERD diagnosis, and indeed, in Non-Erosive Reflux Disease (NERD), one of two major forms (phenotypes) of GERD, may not even be able to detect GERD. Yet, that author demands the RAC incorporate endoscopy as his sole recommendation on GERD diagnosis, even though this is not appropriate.
Furthermore, the RAC report (and the referenced January 2012 Gulf War Research Strategic Plan) calls for comprehensive monitoring of Gulf War veterans' symptoms and health, which VA continues to fail to do. Were VA to do so, there would likely be a myriad of presumptive conditions for Gulf War (and other) veterans, which is likely the reason why Benefits Undersecretary Allison Hickey's secret agenda against Gulf War illness and Gulf War veterans' claims is so relevant to this discussion.
I should add that I'm also intimately familiar with GERD myself, having finally had a 24-hour pH monitoring test **outside the VA**, because VA caregivers refused to do anything other for my GERD than prescribe ineffective palliative medications and tell me to "elevate my bed mattress", failing to recognize that I was having symptoms day and night, supine, seating, standing, and walking. The surgeon who performed my Nissen Fundoplication esophageal reconstructive surgery -- a skilled lung transplant surgeon -- told me with great and sincere concern that it was evident that the acid regurgitation was severe and that it had put me at grave risk for a specific form of lung cancer common in GERD.
VA's failures not just of medical research, but of basic health care, are a recurring source of serious concern for me and for the countless hundreds of thousands of ill Gulf War veterans who VA fails on a daily basis, including in Phoenix, in Madison, Wis. where I was denied necessary health care but thankfully was able to obtain outside the VA (something no veteran should ever have to do), and virtually everywhere around the United States. Beyond the VA's failures to us Gulf War veterans who have what is likely neurologically induced LES-failure GERD that puts us at serious risk of other conditions, little irritates me more than this case of someone pushing "solutions" on GERD who clearly neither understands the science nor the medical care involved with GWI-related GERD. For more on cancer and GERD, see El-Serag 2001 and more. For more on esophageal cancer in GERD, see Chai 2012 and more.
In another example of a highly flawed "recommendation", the argument is made that these highly specific (down to individual research institutions) recommendations "must" be made so that the VA Secretary can request adequate funding from Congress. What the author fails to understand is that Congress provides a very broad line item for medical research and it is up to VA to decide how to spend it. For FY15, the Administration's budget line item request for VA's prosthetics and medical research is $588,922,000 (VA FY15 Budget Request, p. 6). VA doesn't need Congressional authorization to conduct studies on GERD, on prevalence of disease in populations of veterans, on MS, or on much of anything else. VA has a vast research budget and could and should be conducting this sort of research now, a fact that the RAC has made eminently clear in its major reports and recommendations in between major reports.
In recent years, VA staff have without proper oversight somehow seen fit to cut Gulf War research funding from more than $25 million per year down to just $4.86 million... and now tout that they have "increased" Gulf War research funding to just over $7 million as somehow a wonderful thing rather than the actuality, that these very low numbers are a continuation of the very serious cuts they have made to Gulf War research. For people who pay attention to and at RAC meetings, VA research staff have repeatedly made it clear that they currently have authority to expend $15 million on Gulf War research. This week, VA staff stated that if they reach $15 million, they have been told to then take it to $20 million. So, it is very clear that VA research staff have all the authority they need to expend funds on Gulf War research from within the very broad VA research funding line item.
Why anyone would attack some of the best friends Gulf War veterans have ever had, RAC researchers and scientists and medical doctors who fight for us day in and day out through their research and medical care, is beyond me.
Meanwhile, below is a summary provided at the RAC meeting of assertions made and what is really in the report. It's sad that some are attacking what clearly they either haven't read or have failed to understand.
We ill Gulf War veterans must learn to see the difference between those who are actually helping us, and those with mere words that might sound good but are not backed up with actions. And we must learn not to attack our true and sincere friends lest we alienate them and find ourselves all alone.
And, we should all read the new Gulf War Illness CDMRP program booklet, because without a doubt it is this unique treatment-focused program that is providing us with the best hope for uncovering effective treatments for Gulf War Illness.
Finally, for those interested in these issues, next read the RAC 2008 and 2014 reports yourself, and judge them... for yourself. Because this is precisely what VA staff who fear the RAC and us Gulf War veterans do not want you to do.
-A.H.
***
[The following is the text of a document authored by RAC Chairman Jim Binns, discussed at the April 28, 2014 RAC meeting, and entered into the record]
[The following is the text of a document authored by RAC Chairman Jim Binns, discussed at the April 28, 2014 RAC meeting, and entered into the record]
Comparison of topics raised in James Bunker's March 19, 2014 statement for the record with RAC Committee report
The topics raised in the statement for the record are all addressed in the report. Most were in the report prior to March 19, and others were added following the submissions of comments and discussion by committee members. As in the case of all member submissions, it was not deemed necessary or appropriate to include every detail proposed.
1. Follow-on study about sleep dysfunction/sleep apnea
Historically, studies reporting on sleep dysfunction find that Gulf War veterans report greater rates of sleep and circadian disturbances relative to controls (Haley et al., 2004; Peacock et al., 1997; White, 2003). Sleep apnea results from two previous studies were inconsistent: Peacock et al. (1997) reported increased sleep apnea in Gulf War veterans, while Haley et al., 2004 did not. Animal studies modeling exposures experienced by Gulf War veterans showed sleep abnormalities in depleted uranium (Houpertet al., 2005; Lestaevel et al., 2005) and sarin exposed groups (Burchfiel et al., 1976; van Helden et al., 2004).
One study published since 2008 addressed sleep disturbances in symptomatic Gulf War veterans compared to age and obesity-matched asymptomatic Gulf War veteran controls (Table 6). Aminet al. (Amin et al., 2011a) found a significantly increased occurrence of sleep apneas, hypopneas and mild inspiratoryairflow limitation in symptomatic veterans. Treatments utilizing continuous positive airway pressure (CPAP; see Treatments section) have shown early promise as treatments in symptomatic veterans with sleep disordered breathing (Amin et al., 2011b). p. 26
When a pilot treatment study funded by VA or CDMRP shows promising results and is judged to have scientific merit (such as the CPAP intervention in Gulf War veterans with sleep apnea), VA should follow up with a larger trial or other systematic assessment of the treatment’s potential benefits. p. 79
[Comment: Competently-designed research studies take into account the medications a subject is taking. Many other factors are equally important. It is not necessary or appropriate for the report to prescribe this level of detail.]
2. Follow-on studies of GERD.
Research since 2008 continues to indicate that Gulf War veterans report being diagnosed with a variety of medical conditions at significantly higher rates than nondeployed era veterans. These include chronic digestive disorders, respiratory conditions, heart disease and skin disorders. Although consistently reported by Gulf War veterans, these conditions have not been further evaluated or characterized by epidemiologic or clinical studies. p. 36
VA’s longitudinal survey can be effectively used to assess rates of physician-diagnosed medical conditions in Gulf War and era veterans. Survey data should be used to flag conditions of possible importance and followed up with detailed investigation, including any clinical evaluations that are required to determine specific medical diagnoses affecting Gulf War veterans at excess rates. p. 14
[Comment: Studies show that other digestive problems occur in Gulf War veterans at equal or higher rates than GERD, includingirritable bowel syndrome and diarrhea. A general statementencouraging further evaluation of digestive disorders, rather than one singling out GERD, is more far-reaching and appropriate. VA’s longitudinal survey contains eighteen questions concerning digestive symptoms and disorders. The committee has not reviewed literature concerning detailed methodology for conducting digestive studies, and cannot make a scientificrecommendation based on the unsupported statement of one member. These judgments would be made by the principal investigator proposing the study, who would be an expert in the field.]
3. Follow-on studies of cancers, skin diseases and mortality, by location, etc.
Since 2008, research using state cancer registries has suggested that there may be an increased rate of lung cancer in Gulf War veterans. Brain cancer mortality has been shown in two studies conducted by VA to be significantly increased in the subgroup of Gulf War veterans with greatest exposure to oil well fire smoke and to low-level nerve agents released by the destruction of Iraqi facilities at Khamisiyah. In general, cancer risk remains unknown and understudied. p. 36
Lack of current information on overall and disease-specific mortality among U.S. Gulf War veterans is an important issue. No comprehensive information has been published on the mortality experience of U.S. Gulf War era veterans after the year 2000. The 14 years for which no mortality figures are available represent more than half of the 23 years since Desert Storm. Mortality information from the last decade is particularly crucial for understanding the health consequences of the Gulf War, given the latency periods associated with many chronic diseases of interest. Despite specific recommendations over many years from both the current Committee and Institute of Medicine panels, federal research efforts to monitor the mortality experience of 1990-1991 Gulf War veterans remain seriously inadequate. p. 36
Ongoing monitoring and surveillance of the Gulf War veteran population is critical as this veteran group ages. . . Such surveillance should include outcomes described in this document, including Gulf War illness; neurological disorders, including Parkinson’s disease; autoimmune conditions such as multiple sclerosis; brain, lung and other cancers; cardiovascular disorders and dysfunction; sleep dysfunction; adverse reproductive outcomes and birth defects; general ill health and disability; mortality and other disorders and outcomes that emerge as important during the surveillance process. p. 38
A study on the prevalence of “multiple sclerosis, Parkinson’s disease, and brain cancers, as well as central nervous system abnormalities that are difficult to precisely diagnose” in Gulf War and recent Iraq/Afghanistan war veterans was required by Congress in 2008 (Public Law 110-389, 2008, Section 804) and should be carried out. These assessments should be repeated and published at a minimum of 5-year intervals.
A large national VA survey, currently underway, will provide some insight concerning the degree to which Gulf War veterans are affected by excess rates of neurological diseases. This longitudinal survey of VA’s national sample of 30,000 Gulf War era veterans will, for the first time, include a more comprehensive assessment of physician-diagnosed neurological diseases, as reported by Gulf War andnondeployed era veterans. A second national survey, recently funded by DoD, will also query veterans about physician-diagnosed neurological and other diseases. Neither of these surveys, however, is a substitute for the rigorous epidemiological study ordered by Congress or recommended by past RACGWVI and IOM reports. p. 24
Research since 2008 continues to indicate that Gulf War veterans report being diagnosed with a variety of medical conditions at significantly higher rates than nondeployed era veterans. These include chronic digestive disorders, respiratory conditions, heart disease and skin disorders. Although consistently reported by Gulf War veterans, these conditions have not been further evaluated or characterized by epidemiologic or clinical studies. p. 6
Systematic assessment of overall and disease-specific mortality in all Gulf War veterans and in specific subgroups of interest is essential. The results of these assessments should also be published at 5-year intervals. p. 38
Evaluation of health outcomes in Gulf War veterans in subgroups of potential importance is critical as some health outcomes are related to specific exposures and experiences in theater. These subgroups can be defined by suspected or documented exposures in theater, geographical locations in the Gulf War theater or other predictors. p. 39
It is important that VA work with the DoD Congressionally Directed Medical Research Program (CDMRP) to establish guidelines for improved methodology in Gulf War research that can be included in requests for proposals and subject to research application reviews. Such guidelines should include the following:
- Systematic methods for assessing symptoms and other health outcomes in Gulf War veterans.
- Evaluation of health outcomes in Gulf War veteran subgroups of importance—for example, subgroups defined by relevant exposure history or location in theater.
- Consideration of subpopulations with multiple health outcomes. p. 37
4. Follow-on study regarding [CPAP]
When a pilot treatment study funded by VA or CDMRP shows promising results and is judged to have scientific merit (such as the CPAP intervention in Gulf War veterans with sleep apnea), VA should follow up with a larger trial or other systematic assessment of the treatment’s potential benefits. p. 79
5. Follow-up of Wallin study of the rate of multiple sclerosis in veterans from 1990-2007, and by subgroups.
[Comment: The report criticizes the Wallin study because it did not address whether 1990-1991 Gulf War veterans have higher rates of multiple sclerosis:] Despite concerns raised by veterans’ groups in relation to MS rates in Gulf War veterans, as well as Congressional directives and previous RACGWVI and IOM recommendations, the only MS study that included veterans of this era was not designed to determine if Gulf War veterans are affected by excess rates of MS. . . The study did not . . . distinguish 1990-1991 Gulf War veterans from veterans who did not serve in a warzone or those who served in other periods through 2007. p. 24
[The report recommended VA immediately conduct the study of the prevalence of MS in 1990-1991 Gulf War veterans ordered by Congress in 2008:] A study on the prevalence of “multiple sclerosis, Parkinson’s disease, and brain cancers, as well as central nervous system abnormalities that are difficult to precisely diagnose” in Gulf War and recent Iraq/Afghanistan war veterans was required by Congress in 2008 (Public Law 110-389, 2008, Section 804) and should be carried out. These assessments should be repeated and published at a minimum of 5-year intervals. p. 38
Evaluation of health outcomes in Gulf War veterans in subgroups of potential importance is critical as some health outcomes are related to specific exposures and experiences in theater. These subgroups can be defined by suspected or documented exposures in theater, geographical locations in the Gulf War theater or other predictors. p. 39
Gulf War theater exposures, age and other variables likely moderate pathobiological effects and should be carefully addressed in research. p. 12
In some studies that have included female Gulf War veterans, it appears that gender differences may play a role in thepathobiological expression of Gulf War illness and its effects. Gender should be considered whenever possible in mechanistic and treatment research on Gulf War illness. p. 12
6. Follow-up studies of seizures, nerve pain, strokes, and migraines.
Although neurological conditions are a prominent concern for Gulf War veterans and research has found an elevated incidence of amyotrophic lateral sclerosis (ALS), rates of multiple sclerosis, Parkinson’s disease and other neurological diseases (e.g., seizures, stroke, migraines) in Gulf War veterans are currently unknown. Research studies on the prevalence of neurological diseases have not been conducted despite repeated recommendations by this Committee and the Institute of Medicine and explicit legislation by Congress. The prevalence of these disorders is particularly important because they can be expected to increase as the Gulf War veteran population ages. p. 6
[Comment: Training for caregivers is not within the Committee’s statutory and chartered role.]
7. Follow-up studies of immune dysfunction.
Six of eight studies conducted on immune system alterations in Gulf War veterans since 2008 showed immune dysregulation. Research in this area appears to be narrowing in on changes occurring to the expression of certain cell lines. Additionally, changes occurring during or following exercise reiterate that immunological (and other) manifestations of Gulf War illness may only become apparent in specific experimental or clinical settings under “challenge” conditions.
The Committee recommends that research on thepathobiological underpinnings of Gulf War illness and ill health in Gulf War veterans continue to focus on the central and autonomic nervous systems and on immunological andneuroendocrine outcomes in this population in order to identify targets for treatment interventions and outcomes that should be improved during such treatments. p. 12
Increased emphasis should be placed on the study of alterations in regulatory dynamics both within and across the principal regulatory axes, including the endocrine, immune and nervous systems. These should include response to standardized challenges at different time scales, i.e. acute response to exercise, circadian rhythm, and monthly cycles as well as long-term illness
progression. Statistical analysis should be integrative and deployed across these interacting systems whenever possible using methodologies that formally acknowledge regulatory control. pp. 12-13
Studies that evaluate systemic immune and endocrine parameters in animal models, with an emphasis on those parameters that sensitize ill veterans to Gulf War illness, should also be informative. p. 11
Since the 2008 Committee report, the immune-related outcome studies in Gulf War veterans have been primarily performed byKlimas, Broderick and colleagues. p. 68
[Comment: The immune system is receiving close attention. Additonal human studies are already funded at four locations, including follow-on work by Dr. Klimas, plus animal studies.)
8. Improvements in methodology of research studies.
It is important that VA work with CDMRP to establish guidelines for improved methodology in Gulf War research that can be included in requests for proposals and subject to research application reviews. Such guidelines should include the following:
1.
Systematic methods for assessing symptoms and other health outcomes in Gulf War veterans.
2.
Evaluation of health outcomes in Gulf War veteran subgroups of importance—for example, subgroups defined by relevant exposure history or location in theater.
3.
Consideration of subpopulations with multiple health outcomes. p. 9
9. Inclusion of a subgroup of southern watch veterans that would have some exposures but not all, to control for certain exposures.
[Comment: The idea behind this proposal is that veterans who served in the same theater in the mid-1990’s should also be included in research studies because they would have had the same “background” exposures as the 1990-1991 Gulf War veterans (heat, sand, disease, etc.) but not the exposures particularly associated with the war (pyridostigmine bromide, overuse of pesticides, low-level nerve agents, oil well fires, etc.) However, it has already been possible to rule out these background factors as potential causes on the basis of studies already done. In deed, it was possible to rule them out on the basis of the studies conducted prior to the 2008 RAC report. Thus, there is no need to study this additional cohort and incur the fifty percent additional cost of having a third cohort.]
10. Follow-on study regarding Baraniuk L-carosinetreatment findings.
In a study on symptomatic Gulf War veterans, Baraniuk (2013) found that administering an amino acid supplement containing L-carnosine reduced irritable bowel syndrome (IBS)-associated diarrhea (Baraniuk et al., 2013). p. 73
When a pilot treatment study funded by VA or CDMRP shows promising results and is judged to have scientific merit, VA should follow up with a larger trial or other systematic assessment of the treatment’s potential benefits. p. 14
11. Deletion of “Pre-Decisional Draft Strategic Plan for Gulf War Illness Research,” formerly Appendix A.
[Comment: This appendix has been deleted, based on comments from several committee members.]
12. Follow-on studies of treatments where research shows potential benefits.
When a pilot treatment study funded by VA or CDMRP shows promising results and is judged to have scientific merit, VA should follow up with a larger trial or other systematic assessment of the treatment’s potential benefits. p. 14
15 comments:
Excellent analogy Anthony. Years from now, when the issue of Gulf War Illness Advocacy is discussed, your name will without a doubt be included among the true heroes of our generation. I consider it a great honor to know you personally. Moreover, having the privilege of working alongside you on the Integration Panel for CDMRP's Gulf War Illness Research Program is one of the most rewarding experiences of my life.
Know this - ANYONE who attempts to question or attack your integrity or fierce commitment to ailing Gulf War Veterans is not, nor ever will be on good terms with me. You can count on me for backup anytime. Just say the word.
In solidarity my brother.
Semper Fi,
David K. Winnett, Jr.
CAPTAIN, USMC (Ret.)
Since you did not give my full write it I will post my comments in a much better forum. As most of it was and once again will be helped out by some friend that do some very good gulf war research. Some of whom you all like.
http://www.ngwrc.net/RAC/What%20was%20Left%20out%20of%20RAC%20report.pdf
As for the section that was removed form the report, VA did not tell Binns to remove it, Binns did it on his own in the meeting with out talking on anything in the section.
Any committee member can get the copies of the court reporters work if asked in advance. You get a much better record that way. Some thing I learned when running the Kansas Gulf War Health Board that controls Dr. Steel. and did the Gulf war study.
sure until something better comes along yellow.
4. DYSPEPSIA; GERD vs. FUNCTIONAL DYSPEPSIA, Since the 2008 report the Secretary made functional gastrointestinal disorders a presumptive illness for service in the gulf war; but this was based in the lack of any proper research into the cause of the dyspepsia. While a number of surveys of gulf war veterans showed that suffered from the symptoms of dyspepsia at a very high rate, there are no studies on veterans getting proper diagnostic tests to determine if they suffers from GERD or not. The clinical picture is further complicated because symptoms in GERD overlap with those present in functional gastrointestinal disorders (FGIDs), such as functional dyspepsia (FD) and irritable bowel syndrome (IBS). Currently, there is a need to determine if symptoms can be accurately and appropriately assigned to GERD or FGIDs and whether this is of any clinical value in determining assessment and management strategies. (E.M.M. Quigley 2006). We as a committee must make a recommendation to the VA to undertake a survey to determine true rate of GERD in the following subsets of veterans, showing the veterans location in subgroups as per combat and the March 10th date. The study needs to be using an Endoscopy to check for damage. Barium swallow is not good method to use, as it would miss 2/3 of the veterans with the GERD. We advise the Secretary to request from congress the funds for this study as the proper diagnosis of the veteran will help in the proper treatment. We also request that the Gulf war registry exam be changed so that if a veteran has a complaint of dyspepsia he will be tested with Endoscopy to check for damage.
3. Wallin et al., 2012, Rates of multiple sclerosis (MS) were explored in all veterans who served in the military between 1990- 2007. This study found that females of all races now have incidence rates for MS some three times those of their male counterparts. Dr. Wallin ended the research report by stating, “This study stated that more follow-up work is needed”. This committee strongly recommends that the Secretary do a follow up study not only on the MS as per this study within the two years of this date; but this follow-up study needs to be conducted in such a way to incorporate the spirit of Public Law 110-389, 2008, Section 804. WE recommend that the Secretary ask the Congress for the funds needed for the studies and for the changes to Public Law 110-389, 2008, Section 804 to allow the VA to conduct the research. The research could then look at MS, MS type syndromes, Parkinson’s disease, brain tumor / cancer and other neurological diseases with reports every 5 years.
The 2014 edition of the ‘Gulf War Illness and the Health of Gulf War Veterans’ produced by the VA Research Advisory Committee on Gulf War Illness failed the veterans that it is to help. Chairman Binns produced a document that fell short, much like a baseball team that played a great game only to quite after the 7th inning stretch.
That is because Chairman Binns failed to tell the secretary to follow up on any of the pilot studies that the report stated had promise. While the CDMRP had spent over $40 Million in research, Chairman Binns and committee failed advice the Secretary of the VA or any educational research foundation that a continuing study is warranted.
This report falls short for the goal line and thus it does not give the Secretary of the Department of Veterans Affairs the needed advice to request the increased funding for the much-needed research into diagnostic and treatment of the Desert Storm veterans and their families. I do listen to the veterans and I did try to get the report to include the precise recommendation on each pilot study that showed that it could be of benefit to the Desert Storm veterans.
As a committee member, here it what I feel should be in this report as a part of the Executive Summary:
Gulf War Illness Treatment Research Recommendations
As of the Committee’s report in 2008 until December 2013, there had been only four published studies of treatments for Gulf War illness. Of those four published we are able to Recommend the following two for follow-up studies by the Department of Veterans Affairs for gulf war illness.
1. (Baraniuk et al., 2013) Irritable bowel syndrome (IBS) is one of the leading complaint of many Gulf War veterans and many non-veterans too. Dr. James Baraniuk research found that by administering an amino acid supplement containing L-carnosine reduced IBS associated diarrhea (Baraniuk et al., 2013). We recommendation to the Secretary to fund a follow-on study with Dr. Baraniuk and the Georgetown University. This treatment could not only help the gulf war veterans; but the many Americans that also suffer from IBS. The Secretary should request from Congress the funding needed to conduct this cooperative study.
2. (Amin et al., 2011) Amin’s small study of Gulf War veterans with a sleep disordered breathing to receive a nasal continuous positive airway pressure (CPAP) mask or a sham nasal CPAP (Amin et al., 2011b). The CPAP treatment showed significant improvements in the fatigue scores, cognitive function, sleep quality and measures of physical and mental health. This type of research could lead to a treatment that would give back some quality of life without the use of adding medications that can have dangerous side effects. The Secretary should request from Congress the funding needed to conduct a follow-on study of this research.
5. In this report we talk about research showing significantly higher rates of seizures, nerve pains, and strokes,(Kang et al., 2009) Along with migraines (Rayhan et al., 2013). We need to get the VA do follow-up studies on the headaches and work on better treatments in this area working with those at Georgetown peripheral neuropathy. Studies need to look at some causes too. Migraine can be from most anything, but when a veteran has a neck or head injury, the cause is more likely than not that.
As I told Chairman Binns, reducing the all of the Veterans requests down to the following statement was not the answer!
“When a pilot treatment study funded by VA or CDMRP shows promising results and is judged to have scientific merit (such as the CPAP intervention in Gulf War veterans with sleep apnea), VA should follow up with a larger trial or other systematic assessment of the treatment’s potential benefits.”
Well first I would like to point out that the Research Advisory Committee released a report in 2004 also so how does the 2008 report cover 16 years? From the 2008 report this paragraph says the 2008 report covers from 2004-2008 so how is that 16 years (The Committee has convened public meetings on a regular basis to consider the broad spectrum of
scientific research, investigative reports, and government research activities related to the health of Gulf
War veterans. In addition to annual reports on Committee meetings and activities, it has periodically
issued formal scientific recommendations and reports. The Committee’s last extended report, Scientific
Progress in Understanding Gulf War Veterans’ Illnesses, issued in 2004, provided findings and
recommendations on topics the Committee had considered up to that time. The present report provides a
comprehensive review of information and evidence on topics reviewed by the Committee since that time,
as well as additional information on topics considered in the 2004 report.) So please explain to me how the 2008 report covers 16 years. Honesty should not have to be taught at this level it should come naturally!!!!!! Especially when the 2008 report states what is posted above for anyone to read.
Next I would like to address the issue of GERD. Jim Bunker works with hundreds of veterans every month on claims for veterans of the Gulf War How many veterans do the other researchers on the (RAC) work with? How many of these people hear first-hand what the biggest issues and complaints these veterans have and are filing claims for? I do doubt very seriously the other researchers are working with that number of veterans.
Next let’s look at exactly what the Mayo Clinic says on how GERD is diagnosed and see just how far off Mr. Bunker is with what he has said in his statement. I think this will set the record straight that Mr. Bunker does know what he is speaking about. From the Mayo Clinic How to Diagnose Gerd.
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If you're bothered by frequent heartburn or other signs and symptoms, your doctor may be able to diagnose GERD with that information alone. Your doctor may also suggest tests and procedures used to diagnose GERD, including:
• An X-ray of your upper digestive system. Sometimes called a barium swallow or upper GI series, this procedure involves drinking a chalky liquid that coats and fills the inside lining of your digestive tract. Then X-rays are taken of your upper digestive tract. The coating allows your doctor to see a silhouette of the shape and condition of your esophagus, stomach and upper intestine (duodenum).
• Passing a flexible tube down your throat. Endoscopy is a way to visually examine the inside of your esophagus. During endoscopy, your doctor inserts a thin, flexible tube equipped with a light and camera (endoscope) down your throat. The endoscope allows your doctor to examine your esophagus and stomach. Your doctor may also use endoscopy to collect a sample of tissue (biopsy) for further testing. Endoscopy is useful in looking for complications of reflux, such as Barrett's esophagus.
• A test to monitor the amount of acid in your esophagus. Ambulatory acid (pH) probe tests use an acid-measuring device to identify when, and for how long, stomach acid regurgitates into your esophagus. The acid monitor can be a thin, flexible tube (catheter) that's threaded through your nose into your esophagus. During the test, the tube stays in place and connects to a small computer that you wear around your waist or with a strap over your shoulder. Or the acid monitor can be a clip that's placed in your esophagus during endoscopy. The probe transmits a signal to a small computer that you wear around your waist for about two days, and then the probe falls off to be passed in your stool. Your doctor may ask that you stop taking GERD medications to prepare for this test.
• A test to measure the movement of the esophagus. Esophageal motility testing measures movement and pressure in the esophagus. The test involves placing a catheter through your nose and into your esophagus.
So again I ask how is Mr. Bunker Wrong in what he has tried to present and have added into this report.
Next let’s look at this link and see what they call for to diagnose Gerd.
http://www.digestive.niddk.nih.gov/ddiseases/pubs/gerd/#diagnosis
How is GERD diagnosed?
A health care provider may refer people with suspected GERD to a gastroenterologist—a doctor who specializes in digestive diseases—for diagnosis and treatment.
Lifestyle changes and medications are often the first lines of treatment for suspected GERD. If symptoms improve with these treatment methods, a GERD diagnosis often does not require testing. However, to confirm a diagnosis, a person may need testing if symptoms do not improve. People with possible GERD who have trouble swallowing also may require testing.
A completely accurate test for diagnosing GERD does not exist. However, several tests can help with diagnosis:
Upper GI series. While a gastroenterologist does not use an upper GI series to diagnose acid reflux or GERD, the test can provide a look at the shape of the upper GI tract. An x-ray technician performs this test at a hospital or an outpatient center, and a radiologist—a doctor who specializes in medical imaging—interprets the images. This test does not require anesthesia. No eating or drinking is allowed before the procedure, as directed by the health care staff. People should check with their gastroenterologist about what to do to prepare for an upper GI series.
During the procedure, the person will stand or sit in front of an x-ray machine and drink barium, a chalky liquid. Barium coats the esophagus, stomach, and small intestine so the radiologist and gastroenterologist can see theses organs’ shapes more clearly on x rays. The barium shows problems related to GERD, such as hiatal hernias. While an upper GI series cannot detect mild irritation, the test can detect esophageal strictures—narrowing of the esophagus that can result from GERD—as well as ulcers, or sores.
A person may experience bloating and nausea for a short time after the test. For several days afterward, barium liquid in the GI tract causes white or light-colored stools. A health care provider will give the person specific instructions about eating and drinking after the test.
Upper endoscopy. A gastroenterologist may use an upper endoscopy, also known as an esophagogastroduodenoscopy, if a person continues to have GERD symptoms despite lifestyle changes and treatment with medications. An upper endoscopy is a common test used to evaluate the severity of GERD. This procedure involves using an endoscope—a small, flexible tube with a light—to see the upper GI tract.
A gastroenterologist performs this test at a hospital or an outpatient center. The person may receive a liquid anesthetic that is gargled or sprayed on the back of the throat. If sedation is used, a health care provider will place an intravenous (IV) needle in the person’s vein.
After the person receives sedation, the gastroenterologist carefully feeds an endoscope through the mouth and down the esophagus, then into the stomach and duodenum. A small camera mounted on the endoscope transmits a video image to a monitor, allowing close examination of the intestinal lining. The gastroenterologist uses the endoscope to take a biopsy, a procedure that involves taking a small piece of esophageal tissue. A pathologist—a doctor who specializes in diagnosing diseases—will examine the tissue with a microscope and determine the extent of inflammation.
A gastroenterologist diagnoses GERD when the test shows injury to the esophagus in a person who has had moderate to severe GERD symptoms.
Esophageal pH monitoring. The most accurate test to detect acid reflux, esophageal pH monitoring measures the amount of liquid or acid in the esophagus as the person goes about normal activities, including eating and sleeping. A gastroenterologist performs this test at a hospital or an outpatient center as a part of an upper endoscopy. The person can remain awake during the test. Sedation is not required for the test; however, it can be used if necessary.
A gastroenterologist will pass a thin tube, called a nasogastric probe, through the person’s nose or mouth to the stomach. The gastroenterologist will then pull the tube back into the esophagus, where it will be taped to the person’s cheek and remain in place for 24 hours. The end of the tube in the esophagus has a small probe to measure when and how much liquid or acid comes up into the esophagus. The other end of the tube, attached to a monitor outside the body, shows the measurements taken.
This test is most useful when combined with a carefully kept diary of when, what, and how much food the person eats and GERD symptoms that result. The gastroenterologist can see correlations between symptoms and certain foods or times of day. The procedure can also help show whether reflux triggers respiratory symptoms.
Esophageal manometry. Esophageal manometry measures muscle contractions in the esophagus. A gastroenterologist may order this test when considering a person for anti-reflux surgery. The gastroenterologist performs this test during an office visit. A person may receive anesthetic spray on the inside of the nostrils or back of the throat. The gastroenterologist passes a soft, thin tube through the person’s nose into the stomach. The person swallows as the gastroenterologist pulls the tube slowly back into the esophagus. A computer measures and records the pressure of the muscle contractions in different parts of the esophagus. The test can show if symptoms are due to a weak sphincter muscle. A health care provider can also use the test to diagnose other disorders of the esophagus that might have similar symptoms as heartburn. Most people can resume regular activity, eating, and medications right after the test.
Now that we have that out of the way I find it appalling that Mr. Bunker was not allowed to present his solutions into the report. And I and my friends will be contacting our elected officials to ensure that the very members who have chastised Mr. Bunker on his solutions are replaced. I fully believe change in needed in this stale board. This change should have taken place long before now. I will be contacting Chairman Binn’s and the other researchers expressing my disgust on this very issue. I encourage Jim Bunker to keep bringing solutions to the table that will benefit our sick veterans because that is what is long overdue.
For 23 years our veterans have not had that and I guess a select few either current or previous members on the Research Advisory Committee want to ensure that does not start now
Part 1 of 2: A commenter asks the question, “how does the 2008 report cover 16 years?”. If the commenter were to read the report, s/he would see that is simply because it does – well, actually 17 years (1991-2008), though little Gulf War research was actually published in 1991. In section after section, the 2008 RAC report reaches back across all relevant Gulf War research conducted on each topic as far back as it goes and provides a significant level of detailed discussion of relevant studies going back as far as they exist.
The structure of the 2014 report is self-evident that is different from the comprehensive landmark 2008 report, with the 2014 report aiming instead to serve as merely an update to the 2008 report that covered Gulf War Illness research up until that time. The 2014 report further confirms the findings of the 2008 report, and provides updates of new research where findings have been found.
The Executive Summary of the 2008 report makes this point clear, when it says, “The present report provides a comprehensive review of information and evidence on topics reviewed by the Committee since that time [2004], **as well as additional information on topics considered in the 2004 report**. That point is restated in the main body of the report: “The present report summarizes information reviewed by the Committee since its last major report in 2004 and **synthesizes all information considered by the Committee thus far.** (p. 21).
The report goes on to state: “The present report is divided into several sections that reflect different aspects of available information on Gulf War-related health issues. The first section provides an overview of what has been learned from population studies, the large body of epidemiologic research on Gulf War veterans. The second section addresses the cause of Gulf War illness, reviewing what has been learned about the many Gulf War related experiences and exposures that potentially contributed to veterans’ ill health—from the psychological stress of war to the effects of oil well fires, nerve agents, vaccines, and depleted uranium.
The third section addresses the nature of Gulf War illness, reviewing research on biological abnormalities associated with veterans’ symptoms, the relationship of Gulf War illness with multisymptom conditions in civilian populations, and topics the Committee has considered in exploring physiological mechanisms that may underlie veterans’ symptoms. The fourth section summarizes the current status of federal research programs related to the health of Gulf War veterans. Each of the first four sections includes research recommendations related to the specific topics considered.”
Some examples:
In the 2008 report review of whether Gulf War veterans with Gulf War illness are getting better over time, the studies review begin with 1992 and 1996 studies. In the 2014 report, earlier findings noted in the 2008 report are cited in sharply abbreviated form, and the report’s new finding is that little additional information has become available since 2008, and explains why, and notes areas of concern regarding the failure to develop this needed data.
In the 2008 report, the detailed analysis of treatment studies conducted up to that point goes back to the earliest studies conducted in the 1990’s. In the 2014 report, the analyses is of studies conducted since the 2008 report.
Etc. etc. etc. through the entire 2008 and 2014 reports.
Part 2 of 2: The fact that the 2008 report covers the entire period from the Gulf War up until the time of the report is self-evident to anyone who reads and understands it.
Again, the question is why is this commenter attacking when s/he clearly does not understand or has not read the 2008 and 2014 RAC reports.
It should also be pointed out that the commenter attacks the truthfulness of the author of the paper, at the bottom of the post above and provided at the RAC meeting, which accurately describes the content of these two RAC reports. That author is RAC Chairman Jim Binns, who chaired the RAC during this entire period, co-authored all of these reports, and is intimately aware of their contents. Why Ron Brown is calling The Honorable Jim Binns a liar is beyond me when the facts are self-evident and Mr. Binns’ document is clearly completely accurate. Ron Brown owes Mr. Binns an apology, and should immediately delete his comments above calling Mr. Binns a liar.
Furthermore, as a co-author of both the 2008 and 201 reports, and as someone who has actually both read and understood both of them, and the 2004 report, and most of the IOM reports, I can attest to the veracity of the comments Mr. Binns wrote as accurately characterizing them. If there was any doubt, rather than citing a single sentence from the Executive Summary, out of context, and misinterpreting it, the comment author would be wise to read and compare the two reports and see that it’s not very hard to see that it is fact that the 2008 report is a comprehensive report covering from 1991 through 2008, and that is fact that the 2014 report is just as clearly an update to the 2008 report.
GERD:
The commenter clearly doesn’t understand what s/he posted. With regards to an upper endoscopy, the Mayo Clinic information cited states clearly, “An upper endoscopy is a common test used to evaluate the **severity** of GERD.” This is not the same as diagnosing GERD, which can often be done by symptoms alone. The Mayo Clinic information notes that the biopsy taken through the endoscopy, is to “determine the extent of inflammation” – not whether or not there is reflux. Indeed, mild reflux or non-erosive reflux disease (NERD, a form of GERD) may not have yet (or ever) caused esophageal damage.
The Mayo Clinic information calls the 24-hour pH test, “the most accurate test to detect acid reflux”, and then continues: “This test is most useful when combined with a carefully kept diary of when, what, and how much food the person eats and GERD symptoms that result. The gastroenterologist can see correlations between symptoms and certain foods or times of day. The procedure can also help show whether reflux triggers respiratory symptoms.”
The point raised in Mr. Bunker’s public comments appeared to be aimed at finding out how many Gulf War veterans are suffering from GERD by diagnosing them with GERD. The 2014 RAC report calls on VA to broadly perform adequate epidemiological research, as the RAC has doing for years and VA has been failing to do for years (not just on Gulf War health, but on a myriad of other veterans’ health issues). The intent is to determine rates of a substantial array of conditions and symptoms in Gulf War veterans, something that has not been happening to date. VA has even ignored a myriad of laws directing VA to do or contract for specific kinds of studies to determine the rates and prevalence of serious health conditions in Gulf War veterans, including MS, ALS, Parkinson’s, and even Gulf War Illness.
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