Citation Nr: 1205369 Decision Date: 02/13/12 Archive Date: 02/23/12 DOCKET NO. 09-46 625 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Salt Lake City, Utah THE ISSUE Entitlement to service connection for residuals of anthrax vaccine. REPRESENTATION Appellant represented by: The American Legion WITNESS AT HEARING ON APPEAL Appellant ATTORNEY FOR THE BOARD N. Snyder, Counsel INTRODUCTION The Veteran had active service from January 1997 to January 2001. This matter came before the Board of Veterans' Appeals (Board) on appeal from a decision of December 2008 by the Department of Veterans Affairs (VA) Regional Office (RO) in Lincoln, Nebraska. A hearing before the undersigned Veterans Law Judge was held at the RO in Salt Lake City, Utah, in February 2011 (i.e. a video hearing). The hearing transcript has been associated with the claims file. In August 2011, the Board requested an opinion from the Veterans Health Administration (VHA) and that opinion was received in October 2011. See 38 C.F.R. § 20.901 (2011). In In November 2011, the Veteran was sent a notice letter following the Board's receipt of the October 2011 VHA opinion, pursuant to 38 C.F.R. § 20.903. This letter informed him that he had 60 days to submit any additional evidence or argument. In December 2011, the Veteran submitted a December 2011 medical opinion and indicated on the Medical Opinion Response Form included in the November 2011 letter that he waived RO consideration of the evidence. See 38 C.F.R. § 20.1304. FINDING OF FACT The Veteran's current, chronic symptoms did not onset in service and are not the result of service, to include the provision of the anthrax vaccine during service. CONCLUSION OF LAW The criteria for service connection of residuals of the anthrax vaccine have not been met. 38 U.S.C.A. § 1110 (West 2010); 38 C.F.R. § 3.303 (2011). REASONS AND BASES FOR FINDING AND CONCLUSION Service Connection The Veteran contends that he has a cluster of symptoms, claimed as headaches, fatigue, nerve pain, confusion, and dizziness, as a result of in-service anthrax vaccination. In support of this contention, the Veteran has submitted evidence, including copies of a March 1999 congressional report; congressional transcripts; articles documenting that squalene was found in some anthrax vaccines; a September 1999 study (Asa, Cao, and Garry), showing the presence of serum anti-squalene antibodies (ASA) in recipients of the Anthrax vaccine who developed Gulf War Syndrome-like illness and in the majority of the symptomatic Gulf War Syndrome patients ,which was interpreted to suggest that ASA reactivity is a marker for Gulf War Syndrome; and an October 2001 study (Asa, Wilson, and Garry) which concurrently determined that the results were "consistent with the possibility" that "Gulf War Syndrome" is the result of an adjuvant reaction and that the results "strongly suggest that the production of ASA is linked to symptoms of Gulf War Syndrome" and to the presence of squalene in certain lots of anthrax vaccines in some individuals. The authors of the October 2001 study noted that the amount of squalene found in four of the five lots, including lot 30, have been dismissed as too low to have an immunological effect; they believed that although the precise biological significance of low levels remained to be determined, it could not be dismissed summarily. The authors also noted that some personnel receiving vaccinations from squalene-positive lots were ASA-negative and some did not develop signs or symptoms of Gulf War Syndrome. Service connection may be established for disability resulting from personal injury suffered or disease contracted in the line of duty in the active military, naval, or air service. 38 U.S.C.A. § 1110; 38 C.F.R. § 3.303. That an injury or disease occurred in service is not enough; there must be chronic disability resulting from that injury or disease. In order to prevail on the issue of service connection there must be competent evidence of a current disability; medical evidence, or in certain circumstances, lay evidence of in-service occurrence or aggravation of a disease or injury; and competent evidence of a nexus between an in-service injury or disease and the current disability. See Hickson v. West, 12 Vet. App. 247, 253 (1999); Jandreau v. Nicholson, 492 F.3d 1372 (Fed. Cir. 2007); Buchanan v. Nicholson, 451 F.3d 1331 (Fed. Cir. 2006). Service connection may also be established by chronicity and continuity of symptomatology. See 38 C.F.R. § 3.303(b) (2011). Continuity of symptomatology may establish service connection if a claimant can demonstrate (1) that a condition was "noted" during service; (2) there is postservice evidence of the same symptomatology; and (3) there is medical or, in certain circumstances, lay evidence of a nexus between the present disability and the postservice symptomatology. Barr v. Nicholson, 21 Vet.App. 303, 307 (2007) (citing Savage v. Gober, 10 Vet.App. 488, 495-96 (1997)). "[S]ymptoms, not treatment, are the essence of any evidence of continuity of symptomatology." Savage, 10 Vet.App. at 496. In this decision, the Board has considered all lay and medical evidence as it pertains to the issue. 38 U.S.C.A. §§ 5107(b), 7104(a); 38 C.F.R. § 3.303(a). In rendering a decision on appeal, the Board must analyze the credibility and probative value of the evidence, account for the evidence which it finds to be persuasive or unpersuasive, and provide the reasons for its rejection of any material evidence favorable to the claimant. See Gabrielson v. Brown, 7 Vet. App. 36, 39-40 (1994); Gilbert v. Derwinski, 1 Vet. App. 49, 57 (1990). Competency of evidence differs from weight and credibility. Competency is a legal concept determining whether testimony may be heard and considered by the trier of fact, while credibility is a factual determination going to the probative value of the evidence to be made after the evidence has been admitted. Rucker v. Brown, 10 Vet. App. 67, 74 (1997); Layno v. Brown, 6 Vet. App. 465, 469 (1994); see also Cartright v. Derwinski, 2 Vet. App. 24, 25 (1991) ("although interest may affect the credibility of testimony, it does not affect competency to testify"). In determining whether statements submitted by a veteran are credible, the Board may consider internal consistency, facial plausibility, consistency with other evidence, and statements made during treatment. Caluza v. Brown, 7 Vet. App. 498 (1995). February 1998 treatment records reflect the Veteran's four-day history of fatigue, body cramps, congestion, and coughing. After examination, he was assessed with possible pharyngitis, rule out strep. The service medical records indicate that the Veteran was provided doses of the anthrax vaccination in February, March, August, and September 1999. Of these doses, it appears that one, FAV 030, was from a lot which had squalene. The service treatment and examination records reflect no complaints or abnormal findings concurrent with any dose or attributed to any dose. A January 2000 treatment record reflects the Veteran's one-day history of fatigue, dizziness, cramps, weakness, cough, and loss of appetite. After examination, the Veteran was assessed with an upper respiratory infection. A February 2000 treatment record reflects the Veteran's three day history of frequent cough, sore throat, congestion, and headache, which was attributed to pharyngitis. The November 2000 separation examination record indicates that the Veteran denied the existence of any symptom currently manifested, including paralysis, neuritis, swollen or painful joints, psychiatric symptoms, headaches, and dizziness, and it reflects normal clinical findings for all relevant systems. A June 2005 VA treatment record reflects the Veteran's history that for the previous six to eight months, he had been "much more fatigued" and more prone to upper respiratory infections. He reported that he had three episodes of the flu and multiple colds in the previous year and that he had lost 30 pounds in the previous year, though some of this was intentional. He also reported shortness of breath, especially with exertion, though he indicated that he was previously diagnosed with asthma. After examination, he was diagnosed with fatigue and suspected chronic sinusitis. A July 2005 VA treatment record indicates that the Veteran was being seen for a follow-up. The record notes that the Veteran took two weeks of Augmenten and "really ha[d] no complaints." After examination and review of X-ray images and laboratory findings, the Veteran was assessed with allergies. On May 2, 2006, the Veteran presented at the VA emergency room with symptoms including fever, headache, myalgia, and blurred vision. He was admitted to the hospital and ultimately diagnosed with and treated for aseptic meningitis. He was discharged May 3, 2006. A May 11, 2006, VA follow-up record reflects the Veteran's history that he was off antibiotics and feeling better. After examination, he was assessed with resolved viral syndrome. A July 2006 VA treatment record reflects the Veteran's history that he was generally in good health, though he did report a history of sharp groin pain that radiated down the anterior thighs. The Veteran indicated that the pain had improved over the previous week, and the record notes that the Veteran was recently treated at the "STD clinic." An August 2006 VA treatment record reflects the Veteran's history of multiple symptoms, including daily headaches associated with dizziness and unsteadiness, brief shooting pain, and paresthesias. He also reported extreme fatigue for the previous "six months or so" and diminished immune system. After examination, the Veteran was assessed with headaches, fatigue, and paresthesias. A September 2006 VA treatment record reflects the Veteran's history of worsening symptoms. He reported daily headaches, fatigue, numbness at times, and pain in the thighs and genitalia. The record notes that laboratory findings and magnetic resonance imaging (MRI) of the brain were essentially normal. An October 2006 VA urology record reflects the Veteran's history of chronic headaches, fatigue, and sharp groin pain since he was treated for meningitis in May 2006. After examination, the Veteran was assessed with new onset groin and perineal pain of unknown etiology. The examiner noted that the Veteran did describe some occasional back pain. A computerized tomography (CT) scan of the abdomen and pelvis was ordered but was normal. The examiner stated that it was unlikely that subclinical variococeles were the source of the pain. A November 2006 VA neurology record reflects the Veteran's history of stabbing headaches and radicular groin pain since being treated for meningitis in May 2006. Examination was normal. Subsequent treatment records reflect the Veteran's persistent history of symptoms since the episode of meningitis in May 2006. The records also reflect findings of elevated "CPK," though the records indicate that the elevated findings were likely secondary to weight-lifting and body habitus. See, e.g., June, August, and September 2008 and November 2009 VA treatment records. The records indicate that examination and testing has failed to reveal the etiology of the symptoms, though an electromyogram did reveal lumbar radiculopathy in the lower extremities and treatment indicated that the symptoms were improved with doxycycline and prednisone. A November 2008 VA examination record reflects the Veteran's history of daily fatigue, nerve pain (described as shooting pains throughout the body that are paroxysmal in nature), dizziness, diminished concentration, and diminished ability to exercise and engage in physical activity. The Veteran reported that he was in his usual state of health until approximately April/May 2006, when he was admitted to the hospital for what was eventually diagnosed as aseptic meningitis. He indicated that he was taking Prednisone which helped alleviate his symptoms. The examiner noted that the Veteran was concerned that his symptoms were related to the receipt of anthrax vaccine during service, particularly an anthrax vaccine with squalene. The examiner indicated that he considered the Veteran's history, physical examination, clinical experience, and medical literature and resources, "including the up-to-date online version." The examiner reported that review of available medical literature and websites regarding anthrax vaccination indicated that there was no definitive conclusion that anthrax vaccines, such as the one received by the Veteran, posed any specific health concern. The examiner noted that the Veteran received a dose that tested positive for squalene, quantitated at 10 parts per billion. The examiner explained that it had not been demonstrated that such trace amounts of squalene represented a health risk, however. The examiner acknowledged that the record included articles and studies which indicated that the anthrax vaccine never went through large-scale clinical trials prior to its usage and that deployed Gulf War Syndrome patients were significantly more likely to have antibodies to squalene than asymptomatic Gulf War Veterans, which was interpreted to suggest a correlation between the anthrax vaccine and Gulf War Syndrome. The examiner explained that the Armed Forces Epidemiological Board found several shortcomings in the latter study (the study suggesting a link), however, which called into question the validity of the results. The examiner noted that the anthrax vaccine was banned by a federal judge for a period because there was concern that the vaccine led people to develop symptoms similar to Gulf War Syndrome. However, the examiner explained that the ban was lifted after the vaccine was re-examined and reapproved by the Food and Drug Administration (FDA), who had determined that it was "safe and effective." The examiner reported that he found it was less likely as not that the claimed symptoms were due to or the result of the anthrax vaccine. The examiner acknowledged that the Veteran believed his symptoms were the result of the vaccine. The examiner noted that the symptoms onset in 2006, several years after the immunization, however. The examiner explained that considering all the evidence, there did not appear to be a preponderance of medical evidence to support the Veteran's claims of a connection. Furthermore, the examiner found no evidence to support a determination that the anthrax vaccination in any way aggravated any of the claimed conditions. A November 2008 VA mental health examination record reflects the Veteran's history of feeling discombobulated since approximately May 2006. He explained that sometimes when typing, he found himself typing something completely different than he was thinking and that sometimes he had to focus hard on the keyboard to type the information correctly. He added that he felt like he was "just not all there" and linked it to his dizziness and headaches. After examination, the examiner diagnosed the Veteran with "mental disorder not otherwise specified" secondary to the Veteran's "non-specific, enigmatic medical complaints." A March 2010 VA examination record reflects the Veteran's history of headaches, fatigue, nerve pain, confusion, and dizziness, which onset after an episode of aseptic meningitis in 2006. The examiner noted that work-ups had been negative for an etiology. The examiner further noted that there was no documented causal link between the Veteran's symptoms and the anthrax injections. The examiner explained that one would not expect a five-year lapse from the time the Veteran received the injections to the onset of the symptoms. After review of the claims file and the research supplied by the Veteran, the examiner provided addendums in March and August 2010. The examiner reported that the records indicating a link between ASA and Gulf War Syndrome were issued by the company who processed the tests for ASA, noting that "one had to take into account the commercial conflict for the information." The examiner added that the reports contained some information that was "simply not true," such as a claim that there was a link between Gulf War Syndrome and squalene. The examiner explained that there was no current medical literature or research literature which showed causation and/or any association of squalene or ASA as directly related to Gulf War Syndrome. The examiner reported that he had also reviewed the congressional transcripts and noted that at least one of the doctors who testified, who was a Director of a publicly traded biomedical company, had recently developed a blood test for ASA. Thus, the examiner found one must question conflict, though the examiner noted that it appeared that the doctor was sincere in attempting to understand Gulf War illness. The examiner further noted that squalene is a common adjuvant added to vaccinations because it is felt to bolster immune response. "Taken as a whole and together with the previous opinion in 2008," the examiner believed the Veteran's symptoms were not a result of the anthrax vaccine. The examiner explained that, in terms of causation, one would not expect a latent manifestation if the symptoms were due to the anthrax injection and/or any component of squalene. Additionally, the examiner found it noteworthy that the symptoms onset after the Veteran had meningitis. Thus, the examiner found it was not at least as likely as not that the symptoms were the results of anthrax vaccination and more likely than not a manifestation of meningitis. In February 2011, the Veteran submitted an article in which the authors discussed the safety concerns associated with the anthrax vaccine. The article notes that the vaccine was provided to people before any study as to the safety or efficacy had been published. The authors also indicate that "none of the long-term chronic effects" were reported by medical providers, in part because physicians were instructed that only certain adverse effects could be vaccine reactions, such as classic immediate allergic reactions. The authors found this problematic because they believed the adverse reactions could occur after the normal reporting period. The authors then report anecdotal evidence that some health personnel administering the vaccines to military personnel were warned that they would be court-martialed if they kept any record, that vaccines were given over a period of a few days rather than the recommended times, and that nurses noticed that many soldiers became sick after the vaccines but "few" were allowed to report the adverse effects unless hospitalization was needed. The authors explained that the problem with administering multiple vaccines at once was that it could result in immune-depression which made individuals susceptible to opportunistic infections. The authors also noted that there appeared to be cases in which Gulf War Illness had spread to immediate family members. The authors explained that they believed that if stress were added to multiple vaccines given at once and chemical and other toxic exposures encountered during the Gulf War, then immune suppression and opportunistic infections could be a likely outcome in at least a subset of the people with Gulf War Illness and would explain why there was some transmission to immediate family members and why some non-deployed but vaccinated forces had Gulf War Illness. Per the authors, another possible etiology of Gulf War Illness was that there was a contaminant in the vaccines. The authors explained that contamination of commercial vaccine lots can and does occur. The authors reported that a common contaminant was Mycoplasma, which had been implicated in a variety of chronic illnesses. The authors indicated that when thousands of Gulf War Illness patients were examined, evidence of mycoplasmas was found in almost one-half. The authors explained that the involvement of mycoplasmas could explain the transmission of Gulf War Illness to immediate family members and the fact that most of the patients responded to the appropriate antibiotics and eventually recovered. The authors concluded that "what remain[ed] to be determined [was] whether the vaccines used in the Gulf War were the source of the mycoplasmas found in Veteran's blood." The authors noted that a study reporting the presence of ASA had been published which suggested that experimental vaccines were used in the Gulf War. However, the authors believed that vaccines were not the only possible source of microorganisms. In August 2011, the Board requested an opinion from a Veterans Health Administration (VHA) specialist to clarify whether it is at least as likely as not that the Veteran's symptoms are the result of the in-service anthrax vaccines. In October 2011, the Board received a response from a doctor who is board-certified in Occupational and Environmental Medicine and fully qualified as an expert in Gulf War Veterans' multi-symptom illnesses. The specialist noted that she had reviewed the claims file, including the article submitted in February 2011. The specialist noted that the article provided no statistical analysis of the data and only provided a summary which was conjectural in nature. The specialist also noted that the article was published in a journal, the Journal of Nutrition and Environmental Medicine, which was not peer-reviewed and was not a specialty acknowledged by the American Board of Medical Specialties. The specialist further noted that squalene was a naturally occurring substance which was made by the human liver; that a National Academy of Science (NAS): Institute of Medicine (IOM) study had determined there was inadequate/insufficient evidence to determine whether an association does or does not exist between the anthrax vaccination and long-term adverse health effects; that another NAS: IOM study found that "human epidemiologic evidence was not sufficient to establish a causative relationship between any specific drug, toxin, plume, or other agent, either alone or in combination, and Gulf War illness; that the Center for Disease Control and Prevention (CDC) found that there were no known long-term health problems associated with the anthrax vaccine; that independent researchers have not found the anthrax vaccine to be a factor in the development of unexplained symptoms in Gulf War veterans; that the severe problems reported by recipients of the anthrax vaccine did not appear to occur any more often than among non-vaccinated persons; and that the FDA determined that the amount of squalene found in the anthrax vaccines was within the limits determined to be naturally occurring and safe. The specialist reported that a review of the medical record indicated that the Veteran's symptoms developed after he was hospitalized for aseptic meningitis. The specialist noted that the laboratory findings post-hospitalization were negative and the only persistently elevated laboratory findings, elevated Creatinine Phosphakinase (CPK) had returned to normal in January 2010. The specialist further noted that the Veteran did not have an acute adverse reaction to any of the doses of anthrax vaccine; that the Veteran was discharged from service without any evidence of neurological sequelae from any source; and that the symptoms developed acutely after an acute illness acquired six years post-discharge and seven years after receipt of the anthrax vaccine. The specialist stated that aseptic meningitis can, in rare instances, cause chronic fatigue and dizziness in persons who have fully recovered from the acute illness. The specialist reported that peer-reviewed medical literature provided no scientific or medical basis for the development of neurological symptoms subsequent to receipt of anthrax vaccine, even in the short-term. In sum, the specialist found it was not as least as likely as not that the symptoms were the result of in-service anthrax vaccines. In December 2011, a private physician who was one of the authors of the study submitted in February 2011, submitted an opinion in support of the Veteran's claim. The physician is board certified in Internal Medicine and indicated that she had provided testimony on Gulf War illness to Congressional committees. The physician noted that she had reviewed the entire VA medical record, dating up to at least May 2011, and military immunization record. The physician noted that the record included high-normal to high CPK levels. She explained that although several physicians had suggested that the Veteran's elevated CPK levels were due to "high level of exercise," she did not believe this was correct because the Veteran was not capable of high levels of exercise and because three published papers indicated that CPK generally does not rise above normal treadmill exercise. In her statement, the physician responded to the opinion provided by the VHA specialist. The physician indicated that the specialist was correct that the February 2011 submitted article, written in part by the physician, was descriptive rather than statistical and that the journal was not associated with a medical specialty group. She reported that this was true for most other medical journals, however, and she indicated that she had published many other papers on the anthrax vaccine and Gulf War Syndrome and testified on both issues before several Congressional committees, Institute of Medicine committees, and the VA Research Advisory Committee on Gulf War Veterans' Illnesses. The physician reported that although squalene is naturally occurring, when used via injection, it can provide a power immune boost and potentially induce autoimmune illness. She explained that the Finnish Department of Health had concluded that a squalene-containing swine flu vaccine contributed to or caused narcolepsy, an autoimmune disorder, at a rate 12.7 times higher than seen in the unvaccinated. She acknowledged, however, that the amount of squalene used in the Finnish swine flu vaccine was much higher than that found in the anthrax vaccine. The physician noted that the Veteran received one injection from a lot that FDA found contained squalene, adding that whether the small amount (10 parts per billion) was safe had no definitive answer. However, her expert opinion was that the anthrax vaccine was unsafe due to the development of chronic illnesses. The physician then noted that although the National Academy of Science Institute of Medicine (IOM) did find insufficient evidence of a link between any specific agent and Gulf War illness, the report's conclusions state that there was limited but suggestive evidence of an association between deployment to the Gulf War and chronic multi-system illness, and fibromyalgia and chronic widespread pain. The physician believed the anthrax vaccine was the reason that some troops who were not on the ground also experienced symptoms of the Gulf War. The physician then noted that although the CDC determined that the vaccine was safe, the CDC's statements were not supported by the epidemiologic evidence and had been dismissed by multiple expert panels and Congressional reports. She then cites a study which indicates that long-term safety studies are needed. The physician further noted that the specialist missed multiple elevated CPK levels after January 2011, which was consistent with a chronic muscle disease. The physician then disagreed with the specialist's finding that no peer-reviewed medical literature provided scientific or medical basis for the development of neurological symptoms subsequent to receipt of the anthrax vaccine, even in the short-term. She noted that three of 600 inoculated medical personnel in the Army's study of the anthrax vaccine suffered severe neurological or neuromuscular reactions that merited a "VAERS" report and one had myositis; that a MilVax/Vaccine Healthcare Center presentation indicated that neuropathy was associated with large local reactions to the anthrax vaccine; and that the VAERS database included hundreds of reports of neuromuscular disorders after anthrax vaccinations. Finally, the author noted that, in 2004, a director of the Military Vaccine Healthcare Centers Network had described a new illness which was associated with muscle pain, fatigue, sleep disturbance, elevations in CPK, unremarkable nerve conduction studies, and positive response to treatment with lose dose steroids and which was related to anthrax vaccinations. The physician reported that the director showed that booster doses of the vaccine made the patients worse, which confirmed the vaccine as cause of the illness. The physician acknowledged that the five people who became ill with this new disease did so soon after vaccination and not six-to-seven years later. The physician explained that they were the first cases used to establish the syndrome, however, so a close temporal relationship was required. The physician added that whether other soldiers or veterans have developed a similar illness long after vaccination is simply not known and that the director had not yet published her findings on this syndrome in a journal. In sum, the physician believed the Veteran's symptoms were the result of the in-service anthrax vaccine. The physician noted that no etiology had been found for the symptoms and that the symptoms met the definition of Gulf War case and the proposed definition of a prolonged myalgia syndrome, the syndrome proposed by the aforementioned director. Thus, she believed it was likelier than not that the Veteran's condition was caused, or strongly contributed to, by his four anthrax vaccine doses. She added, however, that she did not believe infection had been completely ruled out and that the positive response to doxycycline and the fact that the symptoms onset after an episode of aseptic meningitis was intriguing. Furthermore, she found there was a remote possibility that the Veteran developed an acute infectious disease due to an undiagnosed, fastidious organism which then caused a chronic illness with entirely different features. After consideration of all the evidence, the Board finds service connection is not warranted because although the evidence suggests that the Veteran currently has a chronic condition, the preponderance of the competent and probative evidence does not suggest that the condition onset in service or is causally related to service. Initially, the Board notes that the competent and probative evidence does not suggest that the symptoms onset in service. The service treatment records reflect no histories or findings suggestive of the currently and chronically manifested symptoms, and the evidence indicates that the current symptoms onset in 2006, approximately five years after separation from service. The long time lapse between service and any documented evidence of treatment can be considered, along with other factors, as evidence of whether an injury or disease was incurred in service which resulted in any chronic or persistent disability. See Maxson v. Gober, 230 F.3d 1330 (Fed. Cir. 2000). The Board acknowledges that the service treatment records reflect histories of headache, body cramps, and fatigue. These histories were linked to acute illnesses, however, and based on the absence of evidence of the persistent recurrence of these symptoms in service, to include the absence of such a history at separation, the absence of a history of continuity of symptomatology, and the Veteran's persistent histories that his symptoms onset in 2006 (2005 at the earliest for the fatigue), the Board finds the Veteran's current condition did not onset in service. Furthermore, the Board finds the preponderance of the competent and probative evidence does not indicate that the current condition is causally related to service, to include the in-service anthrax vaccine. The Board acknowledges that the Veteran was provided a dose of a squalene-dosed vaccine in service. The Board further acknowledges that the record includes opinions from a biomedical company, scientists, and physicians that the squalene-dosed vaccine is responsible for Gulf War Illness. The Board finds the probative value of these opinions is outweighed by the probative value of the countervailing evidence, however. See Prejean v. West, 13 Vet. App. 444 (2000) (factors for assessing the probative value of a medical opinion include the physician's access to the claims folder and the Veteran's history, and the thoroughness and detail of the opinion). In this case, the evidence is absent any medical studies showing a causative relationship between the anthrax vaccine, to include the squalene-laced anthrax vaccine, and the development of Gulf War Illness. At most, the studies submitted by the Veteran, and relied upon by the private physician and the biomedical company, show a possible correlation between Gulf War Illness and squalene or the anthrax vaccine. Correlation is not causation; as such, it appears that any opinions asserting a causative link between Gulf War Illness and a vaccine or squalene are based predominantly on speculation and conjecture. In addition, the VHA opinion was undertaken directly to address the issue on appeal. The December 2011 opinion from the private physician offered that physician's view as to the probative weight that should be assigned to the VHA opinion. It is the responsibility of the Board to assess the credibility and weight to be given to evidence. Owens v. Brown, 7 Vet.App. 429 (1995). That physician further pointed out that because extensive evaluations by VA have failed to establish a diagnosis of the Veteran's condition that began in 2006 with his "unusual illness," it was likely caused by his anthrax immunizations, despite the delayed onset. The logical premise of the opinion fails because the question before the Board is not what the appropriate diagnosis is for the condition that onset in 2006, but whether any currently diagnosed chronic disability is related to service. The fact that a definitive diagnosis has not been rendered does not, by default, mean the condition is due to service. As detailed above, the Board finds that the weight of the probative evidence is against a finding of service connection. Service connection may not be based on a resort to pure speculation or even remote possibility. See 38 C.F.R. § 3.102. See also Slater v. Principi, 4 Vet. App. 43 (1993). In this case, the medical evidence has not demonstrated that the anthrax vaccine or the use of squalene as a booster is responsible for Gulf War Illness. The Board acknowledges that no long-term study has yet been conducted; that the Veteran reported a history of fatigue prior to his episode of meningitis; and that a medical expert has opined that the Veteran's symptoms are the result of the anthrax vaccine. The same medical expert has indicated that there are other possible etiologies for the Gulf War Syndrome, however, to include the provision of multiple vaccines on the same day, stress, and biohazard exposure, and in the absence of a study showing long-term effects of the anthrax vaccine or squalene in vaccines, and based on the length of time between the provision of the vaccine and the onset of the symptoms; the fact that the vaccine doses were provided weeks, if not months, apart; the Veteran's competent histories that the symptoms became chronic after he had meningitis; and the determinations of the CDC and IOM that the anthrax vaccine and level of squalene are safe, the Board finds it would be speculative to attribute the symptoms to the anthrax vaccine. In sum, the Board finds the preponderance of the evidence is against the Veteran's claim. Notice and Assistance Upon receipt of a complete or substantially complete application for benefits and prior to an initial unfavorable decision on a claim by an agency of original jurisdiction, VA is required to notify the appellant of the information and evidence not of record that is necessary to substantiate the claim. See 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159; Pelegrini v. Principi, 18 Vet. App. 112 (2004); Quartuccio v. Principi, 16 Vet. App. 183 (2002); Mayfield v. Nicholson, 444 F.3d 1328 (Fed. Cir. 2006). The notice should also address the rating criteria or effective date provisions that are pertinent to the appellant's claim. Dingess v. Nicholson, 19 Vet. App. 473 (2006). The RO provided the appellant pre-adjudication notice by letters dated in August and October 2008. VA has obtained service treatment records, assisted the appellant in obtaining evidence, afforded the appellant examinations, obtained probative medical opinions as to the etiology and severity of disabilities, and afforded the appellant the opportunity to give testimony before the Board. All known and available records relevant to the issues on appeal have been obtained and associated with the appellant's claims file, and the appellant has not contended otherwise. VA has substantially complied with the notice and assistance requirements and the appellant is not prejudiced by a decision on the claim at this time. ORDER Service connection for residuals of anthrax vaccine is denied. ____________________________________________ M. E. LARKIN Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs