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Date Châtelet Châtelet JET INJECTORS = JET INFECTORS Jet Injector / HCV Nexus

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Page 1: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Date

Châtelet

Châtelet

JET INJECTORS =

JET INFECTORS

Jet Injector / HCV Nexus

Page 2: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

✤ Jet Injector / HCV Nexus

Scientific studies cite an association between !mass jet injections and hepatitis C:!

!

! ! 1. Non-Military Population!!

!

! ! ! ! ! ! 2. Military Population

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Page 3: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Darlow (1970) found a slightly increased detection of radio labeled human serum on nozzles of Port-O-Jet injectors. Despite his results he stated “icteric tragedies have been conspicuous by their absence,” meaning there lacked epidemiological evidence, at the time, to support the existence of a problem with hepatitis. Darlow claimed there was no real risk since recipients of the jet injector were not reporting any adverse affects.!!However, Darlow was quick to ascertain his professional opinion despite the notable asymptomatic feature of viral hepatitis and the emergence of non-A non-B hepatitis during his time.!!The medical community has come to understand chronic symptoms of hepatitis C do not appear for ten- to twenty-years after onset. Fast forwarding ten- to twenty-years and what do we observe amongst our non-military and military populations? Numerous diagnoses of hepatitis C, non-A, non-B hepatitis, and hepatic abnormalities. The epidemiological cases that Darlow sought have now emerged.

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Page 4: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Jet Injector and HCV Nexus: Non-Military Population

Pakistan!!Fenner et al. (1988) documented:!!✤ “WHO provided some l00 jet injectors to the national programmes in Pakistan, the Sudan

and Zaire in 1967 and 1968.” (chapter 11, pg 578)!✤ From 1969 to 1970, a mass vaccination campaign was conducted in the Punjab Province of

Pakistan, in which 25,600,000 smallpox vaccinations were administered. (chapter 14, pg 693).!

✤ The city of Lahore resides within the Punjab Province.!✤ “A few disadvantages of jet injectors emerged during the campaigns in which they were

used. In contrast to the simplicity of bifurcated needles, the jet injector required meticulous care and maintenance and considerable repair skills, which could not always be provided despite all the efforts to prepare a detailed, profusely illustrated manual.” (chapter 11, pg 579)

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Page 5: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

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Page 6: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Weniger, Jones and Chen (2008) reported, !!“After smallpox eradication, evidence emerged that its vaccine-delivery devices could transmit bloodborne pathogens such as hepatitis B (HBV) through inherent design defect or unsafe use.”!!“Laboratory and animal model studies, epidemiologic investigations and analyses, and human trials of the Ped-O-JetR and similar MUNJIs once used in smallpox campaigns demonstrated these ‘jet guns’ capable of HBV transmission, even when nozzles were alcohol-swabbed between injections per manufacturer instructions. In the 1990s, the Ped-O-JetR was recalled, its use abandoned by the U.S. military, and contraindicated by WHO and CDC. The latest 2008 study detected HBV contamination by PCR after 8% of MUNJI injections of HBV-carrier volunteers.”!!Conclusion: “Some iatrogenic infections with HBV likely occurred in countries where unsafe MUNJIs and unsterile BNs were used.”

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Page 7: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Epidemiological studies in Pakistan associated HCV with the Smallpox Eradication Campaign: !“It can be seen that in those younger than 20 years of age, the occurrence of hepatitis C is almost at par with the rest of the world (0.5–2%). However, those more than 20 years of age had a very high occurrence, as high as 50% in certain age groups. The time-frame of contraction of the HCV for those individuals more than 20 years of age (approximately 20 to 35 years ago) corresponds with that of the smallpox eradication program conducted in Pakistan from 1964 to 1982. This may indicate the likelihood of a relationship between the high rate of hepatitis C and the administration of the smallpox vaccine in Pakistan” (Aslam & Aslam, 2001).

!“There was a significantly higher likelihood of hepatitis C antibody seroprevalence in individuals vaccinated for smallpox versus nonvaccinated individuals (21.0% vs. 4.6%, P < 0.001, age-adjusted odds ratio, 3.39; 95% confidence interval, 1.36-8.46)… Following adjustment for age, sex, and history of other conditions, including transfusion, the association between prior smallpox vaccination and hepatitis C antibody seroprevalence remained strong and highly significant (multivariate adjusted odds ratio, 6.11; 95% confidence interval, 2.58-14.51)” (Aslam et al., 2005).

CONCLUSION:

“These results suggest that the widespread prevalence of hepatitis C infection in Pakistan may be an unintended consequence of the country's smallpox vaccination program and that blood transfusion is also a significant risk factor” (Aslam et al., 2005).

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Page 8: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

In conclusion:!!✤ Fenner et al. (1988) reported Jet Injectors were used in the smallpox

eradication campaign in Pakistan.!!

✤ Weniger, Jones & Chen (2008) reported Jet Injectors likely transmitted blood-borne pathogens, such as Hepatitis B Virus, during the smallpox eradication campaigns.!!

✤ Aslam et al. (2005) found a statistical association between the smallpox eradication campaign in Pakistan and hepatitis C.!

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Page 9: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Brazil!!!Ivantes, Silva & Messias-Reason (2010) conducted a cross-sectional survey on the prevalence of hepatitis C antibodies in Tamboara, Brazil. The study assessed the risk factors of 816 residents.!!!“The authorities responsible for health care in Tamboara had a hypothesis that the high prevalence of anti-HCV was related with jet injection devices. Up to 1990, vaccination with this technique was used especially for prevention of yellow fever in Brazil. An epidemiological survey by Souto et al. in a Center-West Brazilian city suggests that the jet injection device has facilitated hepatitis B contamination in the population. In this study, some healthcare procedures related to anti-HCV transmission were identified by univariate analysis. Injections with glass syringe, vaccination with jet injection devices and blood transfusion before 1993 were significant risk factors.”!!!“By univariate analysis, the significant risk factors for HCV infection were as follow: familial history of hepatitis (p = 0.04), injection with glass syringe (p < 0.001), vaccination with jet (needle-free) injection devices (p = 0.034)…” (Ivantes, Silva & Messias-Reason, 2010).

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Page 10: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Jet Injectors and HCV Nexus: Military Population

Flawed Studies!

Dominitz et al. (2005), aka VA Cooperative Study 488, assessed the prevalence and incidence of Hepatitis C Antibodies amongst veterans using VHA. Results found 52 veterans had HCV Antibodies. !

“Among those testing positive for hepatitis C antibody, 78% either had a transfusion or had used injection drugs.”!

“Although some military-related risk factors were associated with seropositivity in bivariate analyses, none was significant after adjusting for intravenous drug use and nonparticipation. Likewise, despite reports of hepatitis B transmission with air injection, this common exposure was not significantly associated with HCV in our multivariate analysis.”

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Page 11: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Flawed Studies!!Flaws in Dominitz et al. (2005):!!The VA has attributed the etiological causes for over 287,000 veterans positive with hepatitis C antibodies (Department of Veterans Affairs, 2010) based on a study that only assessed 52 veterans with hepatitis C antibodies. Herein the sample size of the study is only two-thousandths of a percent (0.02%) of the population. !!Dominitz et al. is also grossly outdated. The study sampled veterans in 2001 at which time the Veterans Health Administration (VHA) had roughly 100,000 veterans with hepatitis C in their system. This figure is estimated from Butt and colleagues (2007) who reported by 2003 VHA had 113,927 veterans with HCV in their care. By 2014, the VA reported over 174,000 veterans with HCV within VHA. Therefore, from 2001 to 2014 we can estimate the number of hepatitis C veterans within VHA’s system rose by over 74,000 people, or rather by 74 percent. There is no guarantee that the risk factors for these additional veterans, who were new patients within the VHA system, are reliably represented in that study.!!Despite the VA’s denunciation of jet injectors, the administration admitted “It is possible that if transmission of hepatitis C did occur via the use of jet injectors, it happened in isolated circumstances, or on a small scale. Such events would be difficult to detect in a population-based prevalence study like VA Cooperative Study 488” (Department of Veterans Affairs, 2006).

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Page 12: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Flawed Studies!!Briggs et al. (2001) also conducted a study to assess the prevalence of and risk factors for hepatitis C within a VA Medical Center. The study found 185 veterans, or rather 17.9 percent of the sample, had hepatitis C.  Their study purported,!!

“History of vaccine in combat or vaccination with an air gun [another name for a jet injector] did not correlate with HCV status (data not shown).  However, these questions were added to the questionnaire during the conduct of the study and information was available from only 211 respondents.”!

!The researchers explicitly disclosed that not all of the sampled veterans received the same questionnaire consisting of the question to evaluate for jet injectors.  In fact, the researchers stated only 211 veterans or rather 20.4 percent or rather one-fifth of the sampled population received an updated questionnaire.  Yet regardless of this inconsistency the researchers ultimately denounced an association between hepatitis C and jet injector vaccinations within their study.

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Page 13: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Reputable Study!!Boscarino et al. (2014) had patients fill-out questionnaires to identify Hepatitis C risk factors. Boscarino assessed 526 Vietnam-era veterans with Hepatitis C. !!Boscarino’s study implicated the jet injector as a risk factor amongst veterans. “Among veterans reporting ‘other’ exposures, the reason for this was primarily due to veterans reporting exposure to vaccinations or shots in the military.”!!Boscarino further stated,!!

“Vaccinations in the military during the Vietnam War era were often done with pneumatic air-guns, en masse, during military induction and  prior to overseas deployments. Typically, service members received multiple injections as they moved through these vaccination lines. Given this vaccination method, it was not uncommon for veterans to be bleeding by the time they reached the end of the line.”!

!The researcher added, !!

“it is noteworthy that neither history of drug abuse treatment nor history of injection drug use was associated with Vietnam era veteran status…studies related to the prevalence of risk factors for HCV among veterans may be biased [hence, referring to Dominitz and Briggs’ studies]. While our findings are not conclusive and may reflect recall, response, and/or sampling biases, they may justify the need for additional research. It is important to stress that the military service exposure findings found for the Vietnam era veterans was not part of our original survey design, but emerged from the coding and analysis of open-ended responses after survey completion.”

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Page 14: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

Board of Veterans’ Appeals Court Cases Citing Jet Injectors!1993 - 2016

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Page 15: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

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Page 16: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

The Board of Veterans’ Appeals granted 139 cases citing the jet injector. Out of these cases:!!1. 47 cases explicitly rendered that the jet injector was the etiological cause of veterans’

hepatitis C infection. Meaning in each case medical professionals familiar with the veteran’s case and a Veterans Law Judge both found the jet injector to be the veteran’s source of infection. !

! ! These cases can be further broken-down:!!

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Page 17: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

In 25 of these 47 cases, the jet injector was the veterans only risk factor for hepatitis C. This is worth repeating, in these 25 cases the only risk the veteran ever experienced was the jet injector. Herein are 25 documented cases which substantiate the nexus between hepatitis C and military jet injector vaccinations. (Note: The following are citation numbers to Board of Veterans Appeals court cases).

0724747!0737147!0811510!0814816 !0841041!0945788!1016262!1105990!1110922!1113197

1140321!1204519!1224138!1234244!1428737 !1454128!1411262!1418447!1444711!1520374!

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1534813!1525003!1506800!1606528!1628584

Page 18: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

In 10 of these 47 cases, either the veteran or the VA cited possible other causes for HCV which in actuality are not actual risk factors, leaving the jet injector as the only actual risk. (Note: The following are citation numbers to Board of Veterans Appeals court cases).

0531165!0518599!0630813!0724695!0928872!1520172!1519478!1538486!1628702!1616758

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Page 19: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

In 12 of these 47 cases, veterans’ military jet injections were found to be a greater risk factor than other inservice and/or non-service risk factors purported. Meaning these other risk factors were deemed unlikely as the source of veterans’ hepatitis C infection when compared to these veterans’ military jet injection experiences. (Note: The following are citation numbers to Board of Veterans Appeals court cases).

0601461!1038373!1101309!1207290!1231843!1309730!1416517!1424481!1431207!1417668!1436104!1553509

Page 20: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

In 20 cases, veterans’ military jet injections were found to be in equipoise, that is equal to, to other non-service risk factors. (Note: The following are citation numbers to Board of Veterans Appeals court cases).

0509557!0608394!0837526!0841711!1028817!1037454!1101581!1103336!1211881!1340016

1410959!1416401!1437635!1544344!1530531!1623406!1620439!1606583!1646260!1648273

Page 21: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

!2. 69 cases rendered that veterans’ military exposures, which included jet injector

inoculations, were the etiological cause of the veterans’ hepatitis C infection. Meaning the renderings in these cases found multiple inservice risk factors were the probable source of veterans’ hepatitis C. Veterans need only prove that their inservice risk factors of acquiring hepatitis C were equal to or greater than any non-service risk factors. Therefore, determining amongst multiple inservice risk factors as the cause of hepatitis C is unnecessary. (Note: The following are citation numbers to Board of Veterans Appeals court cases).

0401390!0412360!0431544!0512564!0531931!0617051 !0613784!0706485!0725073!0707790!0732398!0719864

0813838!0833161 !0817872!0832288!0914241!0925662!0903041 !0915834!0908613!0915383!0924446!0927938

0938394!1024366 !1003545!1024024!1024254 !1036827!1041083 !1027816!1113862!1116389!1132255!1145135

1142926!1214128!1232068!1200027!1224304!1325994!1328188!1316957!1331664!1315656!1330738!1428443

1418796!1417533!1506919!1507259!1521791!1524763!1548806!1508182!1552751!1608006!1631490!1635524

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1637167!1639801!1609696!1605171!1601140!1604008!1622345!1626782!1644902

Page 22: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

!!

3. One case explicitly rendered that the jet injector was the etiological cause of the veteran’s hepatitis B infection.!

!1139163!

!4. One case rendered that the veteran’s military exposure which included jet injector

inoculations was the etiological cause of the veteran’s hepatitis B infection; and !!

1116389!!5. One case found the jet injector caused an adverse condition in a veteran’s upper arm.!!

09627110

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(Note: The following are citation numbers to Board of Veterans Appeals court cases).

Page 23: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

References

✤ (Aslam & Aslam, 2001) Aslam M & Aslam J. “Seroprevalence of the Antibody to Hepatitis C in Select Groups in the Punjab Region of Pakistan.” Journal of Clinical Gastroenterology. 2001 Nov;33(5): 407-411. !

✤ (Aslam et al., 2005) Aslam M, Aslam J, Mitchell BD, Munir KM. “Association Between Smallpox Vaccination and Hepatitis C Antibody Positive Serology in Pakistan Volunteers.” Journal of Clinical Gastroenterology. 2005 Mar;39(3):243-6. !

✤ (Boscarino et al., 2014) Boscarino JA, Sitarik A, Gordon SC, Rupp LB, Nerenz DR, Vijayadeva V, Schmidt MA, Henkle E, Lu M. Risk factors for hepatitis C infection among Vietnam era veterans versus nonveterans: results from the chronic hepatitis cohort study (CHeCS). J Community Health. 29 March 2014.!

✤ (Briggs et al., 2001) Briggs ME, Baker C, Hall R, Gaziano JM, Gagnon D, Bzowej N, and TL Wright. Prevalence and risk factor for hepatitis C virus infection in an urban Veterans Administration medical center. Hepatology 2001, 34:1200-1205.!

✤ (Darlow, 1970) Darlow HM. Jet vaccination. British Medical Journal 4(734):554, 1970.!

✤ (Dominitz et al., 2005) Dominitz JA, Boyko EJ, Koepsell TD, Heagerty PJ, Maynard C, Sporleder JL, Stenhouse A, Kling MA, Hrushesky W, Zeilman C, Sontag S, Shah N, Ona F, Anand B, Subik M, Imperiale TF, Nakhle S, Ho SB, Bini EJ, Lockhart B, Ahmad J, Sasaki A, van der Linden B, Toro D, Martinez-Souss J, Huilgol V, Eisen S, Young KA. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005 Jan;41(1):88-96.!

✤ (Fenner et al., 1988) Fenner F, Henderson DA, Arita I, Je⟩ek Z, Ladnyi ID. Smallpox and its Eradication, Geneva: World Health Organization, 1988 (ISBN 92 4 156110 6).Available at: http://www.who.int/smallpox/9241561106.pdf.!

✤ (Ivantes, Silva & Messias-Reason, 2010) Ivantes PC, Silva D & I Messias-Reason. “High Prevalence of Hepatitis C Associated with Familial History of Hepatitis in a Small Town in South Brazil. Efficiency of the Rapid Test for Epidemiological Survey.” Brazil Journal of Infectious Disease 2010;14(5):483-488.!

✤ (Weniger, Jones & Chen, 2008) Weniger BG, Jones TS & RT Chen. “The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods.” 2008. © 2017 Jet Infectors. All Rights Reserved. !

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Page 24: Jet Infectors - 6. Jet Injectors / HCV Nexus · 2017-09-01 · Jet Injector and HCV Nexus: Non-Military Population Pakistan!! Fenner et al. (1988) documented:!! “WHO provided some

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