Communication: Oct. 2015 Petition to Secretary McDonald to treat all Military Veterans with Hepatitis C within the Veterans Health Administration

Secretary McDonald asks Dr. David Ross Director, HIV, Hepatitis, and Public Health Pathogens Programs to respond to HCVets.com concerns. The following emails were exchanged.
 

Dear Mr. Brown:

Thank you for your recent e-mail to Secretary McDonald regarding screening Veterans for infection by hepatitis C virus (HCV). Early diagnosis and linkage to care for Veterans with chronic HCV infection is a high priority for the Department of Veterans Affairs (VA), given the recent introduction of more effective and less toxic treatments for this disease.

HCV is transmitted by both blood borne and sexual routes; the former include exposure to infected blood through mechanisms such as blood transfusion and needle sharing in the setting of injection drug use. There have been a number of studies performed by VA researchers to define the specific factors associated with HCV infection. As you note, one of the key studies was published in 2005 and described the characteristics of Veterans who had confirmed chronic HCV infection (Dominitz JA et al. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers.  Hepatology 2005Jan;41(1):88-96.). Although no research study is perfect, this study played a key role in bringing to light the increased risk for HCV infection in Veterans, and supplied the best data we have on risk factors in Veterans for HCV infection.

Importantly, one key risk factor identified by this study was service during the Vietnam War era. While the reasons for this association are not completely clear, it has been clearly incorporated into VA criteria for screening Veterans for HCV infection, which are publicly available at http://www.hepatitis.va.gov/provider/reviews/screening.asp.

You appropriately raise the question of whether use of jet gun injectors for immunization could represent a risk factor for HCV infection. Although this is biologically plausible, the Dominitz study and others have not found evidence that jet gun immunization is a significant risk factor for HCV infection. While these studies could not exclude this possibility, given the sample size and design features of these research efforts, jet gun immunization is unlikely to be as significant a risk factor for Veterans in VA care as the identified risk factor of Vietnam-era service and other evidence-based risk factors connected to proven routes of transmission. These represent our best method for efficiently and effectively identifying all Veterans who are affected by HCV.

In January 2014, VA updated its criteria for screening Veterans for HCV by adding birth cohort testing – i.e., offering HCV testing to Veterans born between 1945 and 1965 inclusive – to the list of criteria for screening. The estimate that there may be as many as 42,000 Veterans with HCV infection have not been diagnosed is based on the proportion of Veterans in VA care in the 1946-1965 birth cohort who have been tested for HCV. As of FY 15, approximately 68% of Veterans in VA care in the birth cohort had been tested for HCV, compared to approximately 50% for the general US population. We are, of course, implementing programs to increase the percentage of Veterans in the birth cohort who have been tested for HCV, along with other Veterans in care with recognized risk factors. Of note, over 90% of Veterans in VA care with a positive initial screening test have had confirmatory testing performed, compared to less than 50% of the general US population.

I hope this information is helpful to you. Thank you for your support of our efforts to identify and appropriately treat all Veterans in VA care with HCV.

 

David Ross, M.D., Ph.D., M.B.I.

Director, HIV, Hepatitis, and Public Health Pathogens Programs

Office of Patient Care Services/Specialty Care (10P4E)

 

Associate Clinical Professor of Medicine

George Washington University School of Medicine and Health Sciences

 

Staff Physician, Infectious Diseases Section

Washington, DC Department of Veterans Affairs Medical Center

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Dr. Ross,

Subject: 42,000 veterans who are MIA within the VHA. 

In a draft document titled, Department of Veterans Affairs: Hepatitis C Infection and Drug Therapy, dated July 25, 2014, the VA estimates “there could be approximately another 42,000 HCV patients who have not yet been tested.”  This figure was reported again last May in a Newsweek article. Mind you this comes  two-years after the CDC heavily encouraged all baby boomers to be tested for hepatitis C and heavily advertised the following recognized risk factors of injection drug use, blood transfusion and organ transplant before 1992, receiving clotting factor concentrates before 1987, being a hemodialysis patient, being a healthcare worker, being HIV positive, having signs or symptoms of liver disease, and being a child born to a HCV positive mother.  Additional risk factors identified by the VA include: tattoos, acupuncture, engaging in high-risk sexual behavior, having a venereal disease, and being in jail more than 48 hours.  

If 42,000 veterans do not fit into the risk factors recognized by the CDC and VA, then why would they think to be tested?  Presumably, because these veterans, like my father and like many other veterans across this great nation, do not conform to those risk factors.  For many veterans their only risk was their military vaccinations via jet injection. Recognizing this as a high risk factor for hepatitis C will help identify and treat these 42,000 veterans who are MIA within the VHA. 

The Board of Veterans Appeals has granted a significant number of jet injector cases.  A review of case law from 1992 to 2014 found the BVA had rendered in 96 cases there existed a positive nexus between jet injectors and hepatitis C. Included amongst these is my father’s case.  In 2014 the BVA rendered that 1) my father died due to complications of hepatitis C, and 2) that he, at least as likely as not, contracted hepatitis C from his military jet injector vaccinations as he had no other risk factors for the virus. However, many cases have been denied because the jet injector was cited by your staff as not being a recognized risk factor, despite the fact that the jet injector was the veteran-claimants only risk factor for hepatitis C.

The transmission of hepatitis C via jet injectors has been widely recognized. Since the reusable devices used within the DoD from 1955 to 2006, jet injector manufactures have developed newer designs that use disposable parts to prevent the cross-contamination of blood and blood-borne pathogens. However, the only agency to not recognize the risks and hazards of the jet injector is the Department of Veterans Affairs. Studies conducted by the VA that denounce jet injectors as a risk factor consisted of flaws. Let me prove my point. 

 

Briggs and colleagues (2001) and Dominitz and colleagues (2005) both assessed the prevalence of and risk factors for hepatitis C amongst randomly selected veterans enrolled in Veterans Health Administration healthcare (VHA).  However, both of these studies contained flaws for assessing the etiological causes of veterans with hepatitis C.  Both of these studies inaccurately denounced jet injector transmission as a risk factor. 

Briggs and colleagues (2001) 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. 

 

VA Cooperative Study 488, by Dominitz and colleagues (2005), found 52 veterans had hepatitis C.  This equated to a 5.4 percent prevalence, which was three times greater than within the general population (1.8 percent).  In assessing risk factors, the highest rates of hepatitis C were found amongst veterans who injected drugs, who served during the Vietnam war era, who served more than 48-hours incarcerated, and who had tattoos.  An association between military exposures (such as, combat duty, exposure to blood in combat, and jet injector inoculations) and hepatitis C were found to be statistically insignificant amongst the hepatitis C veterans studied (Dominitz et al., 2005). 

 

Based upon this study, the VA has attributed the etiological causes for over 287,000 veterans positive with hepatitis C antibodies based on a study that only assessed 52 veterans with hepatitis C.  Herein the sample size of the study is only two-thousandths of a percent (0.02%) of the population.  

Additionally, VA Cooperative Study 488 is grossly outdated.  The study sampled veterans in 2001 at which time VHA had roughly 100,000 veterans with hepatitis C in their system.  Yet from 2001 to 2014 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. 

 

VA Cooperative Study 488 is a unique study that properly assessed the prevalence of hepatitis C amongst a random sample of veterans.  In this study, veterans were randomly selected and then assessed on whether or not they had hepatitis C.  However, this is the limits to this study.  Assessing the etiological causes of only 52 veterans with hepatitis C, as VA Cooperative Study 488 did, is a weak claim in identifying the risk factors for a larger population.  This is evidenced based upon the data, which reported spending more than 48 hours in jail posed a greater risk for hepatitis C than military service (which included combat duty and jet injections). Now remember, hepatitis C is only transmitted through blood-to-blood contact so this claim is preposterous.  Moreover, the researchers themselves stated it would be difficult to detect a nexus between hepatitis C and jet injectors within their data because the study was population-based.  However, VA Cooperative Study 488 has been heavily relied upon for guiding public health policy amongst veterans and for testing at risk populations. 

 

Sir, there exists an abundance of information on this issue. I can show you numerous studies that report jet injectors produced blood at the injection site, that jet injectors were cited as transmitting several diseases from one patient to a subsequent patient, and laboratory studies that demonstrate a theoretical risk of hepatitis C transmission. I can show you studies that explicitly state jet injectors had design faults that made the devices inherently unsafe. I can supply you with statements by international and national health organizations, erroneous denials by the BVA, erroneous statements by VA adjudicators, nurses, and physicians...I can provide you the citations of the 96 cases whereupon the BVA appropriately recognized this nexus . I can show you a jet injector manual and Army nursing manual that states proper jet injection technique and compare it to photos of United States servicemen and servicewomen receiving jet injections where injection procedures were disregarded. I can furnish statements from veterans and corpsmen who utilized the jet injectors that there was blood present during the vaccination campaigns.

 

Often politics hinders progress. My concern is not politics but the lives of 42,000 men and women who are unknowingly living with a hepatitis C. 

Will you help me?

 

Sincerely,

 

Shaun Brown

Dr. Ross, 

 

I am greatly appreciative in receiving a response, let alone from you, the top doctor on HCV within the VA. Although sir, I respectfully disagree. Your response, “biologically possible but improbable,” has been the reflexive response of the VA not only for HCV but for every other large epidemic within the VA since WWII.

 

As already discussed VA Cooperative Study 488 only accessed 52 veterans with HCV and is grossly outdated and does not represent the 74,000 veterans that joined VHA after Dominitz’s study. 

 

Boscarino and colleagues (2014) conducted a study titled, “Risk Factors for Hepatitis C Infection Among Vietnam Era Veterans Versus Nonveterans: Results from the Chronic Hepatitis Cohort Study (CHeCS).” Like Dominitz and Briggs’ studies, Boscarino had patients fill-out questionnaires to identify HCV risk factors. Boscarino assessed 526 veterans with HCV. 

 

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.”

 

“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 stated, “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.”

 

Obviously, you will find some objection to this study for a rebuttal to discredit the jet injector. So lets set the epidemiological studies aside. 

 

Bottom line: A risk factor is a risk factor, plain and simple. I am not talking about determining the etiology of veterans’ HCV. I am talking precisely about the inconsistent identification of the jet injector as a risk factor for hepatitis C by VA employees. Some VA staff appropriately acknowledge the jet injector as a risk factor and others erroneously discredit it. 

 

The VA would never allow its staff to recognize the nexus of, per se, blood transfusions and HCV in one case but discredit this same exact nexus in another case. Doing so would be preposterous. Yet this is what is occurring with jet injectors. To allow this inconsistency to remain within VA is iniquitous. Any blood-to-blood contamination poses a risk of infection. 

 

MANY have acknowledged the jet injector as a risk factor. The VA is the only agency that does not accurately recognize the risks and hazards of jet injectors. 

 

Patents for newer generation jet injectors with disposable parts, known as disposable cartridge jet injectors (DCJI) implicate prior jet injectors with reusable parts as being inherently unsafe. See:

-Dunlap KW. “Dry Disposable nozzle assembly for medical jet injector.” United States Patent 5,062,830. 5 November 1991.

-Landau S. “Multiple use needle-less hypodermic injection device for individual users.” United States Patent 5,782,802. 21 July 1998.

-Smoliarov BV, Rogatchev VT, Katov VN, Felton A, Leon N. “Method and apparatus for removing cap from medical device.” United States Patent 6,626,871 B1. 30 September 2003.

 

Or look at Mitragotri’s 2006 study which captured through microcinematography that during a jet injection there is extensive splash-back of fluid. That is to say after the fluid penetrates the skin it splashes back on to the jet injector nozzle and into the nozzle orifice. (Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nature Reviews Drug Discovery 5:543–548, 2006.)

 

These findings have been substantiated in published studies by:

-Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.

-Suria H, Van Enk R, Gordon R, Mattano LA Jr. Risk of cross-patient infection with clinical use of a needleless injector device. Am J Infect Control. 1999 Oct; 27(5):444-7.

-Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.

 

This finding was even noted in the 1962 patent by Aaron Ismach, the co-inventor of the Ped-O-Jet, the most widely used jet injector within the DoD. Ismach claimed his injector prevented “sucking fluid back from a patient either during or after the firing cycle.” (see: Ismach, Aaron. “Multi-dose jet injection device.” United States Patent 3,057,349. 9 October 1962.) 

 

However, Hoffman’s study found retrograde flow, aka splash-back, did occur in the Ped-O-Jet.

 

Sir, I can go on and on. There is an abundance of evidence demonstrating that jet injectors widely used within the DoD from 1955 to 1997 contained inherent risks that allowed the devices to act as vehicles for the cross-contamination of blood and blood-borne pathogens. 

 

I am asking that the jet injector be officially recognized by the VA as a risk factor.

 

In so doing, 42,000 veterans unknowingly living with HCV will, hopefully, come forward and be tested; will prevent obfuscating the real risk factors of HCV by vague classifications such as “Vietnam era veterans;” and will create consistency throughout all VA employees. 

 

This is the ethical and moral response to take. In no way will this change the weighing of veterans risk factors. The willful misconduct of veterans will still be noted and appropriately weighed.

 

After all these years will you, acting as the authority of the VA, finally and appropriately officially recognize the jet injector as a risk factor for HCV?

 

Most appreciative,

Shaun Brown

 

P.S. I have another topic to discuss with you after this one.

 

CC: Senator Schumer

 We have received no further communication as of February 18. 2016.. 

 

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Response from Dr. Ross - June 22, 2016

Dear Mr. Brown,

While this is not a direct response to your request below, I wanted to give you a quick update about your e-mail below. I’m in the process of pulling together a meeting of VA subject matter experts on this subject to provide information to Secretary McDonald. I agree with you that this issue is important and know that it is one that you have spent considerable time researching. I will work to move this forward.

David Ross, M.D., Ph.D., M.B.I.
Director, HIV, Hepatitis, and Public Health Pathogens Programs
Office of Patient Care Services (10P4I)
U.S. Department of Veterans Affairs

Staff Physician, Infection Disease Section
Washington, DC VA Medical Center
Associate Clinical Professor of Medicine
George Washington University School of Medicine and Health Sciences
1717 H Street,
NW Washington, DC 20006
Mailing Address: 810 Vermont Avenue NW, Washington, DC 20420