The Downfall of Ped-O-Jet Injectors Within the U.S. Military

September 21, 2017

The Department of Defense’s (DoD) ban on the use of multi-use nozzle jet injectors was swift and well documented. Although, the documents were later removed and, in one case, destroyed by law after five years. Thankfully through Dr. Weniger, web.archive.org, and talented researchers these documents have been saved. For the first time, the change within DoD’s vaccination protocols, from the fall of multi-use nozzle jet injectors to the rise of disposable-use cartridge jet injectors is thoroughly outlined.

 

Timeline:

 

PED-O-JET_____________________________________________________________________________
1995
Keystone Industries acquires the assets and trademarks of Ped-O-Jet from a bankrupt sale.

1996 Oct. 2-4
John Stengel, Production Manager of the Ped-O-Jet at Keystone Industries, attends a joint meeting by CDC and WHO to discuss the safety and improvement of jet injectors. A CDC expert stated, “Jet injectors, such as Ped-O-Jet, are not particularly easy to contaminate, but once they are contaminated, they can indeed transmit disease” (Fields, 1996).

1997 Mar. 18-19
Members of Keystone Industries attended a WHO meeting to further discuss the safety and design of jet injection devices for mass immunizations. Several studies were presented which documented the Ped-O-Jet indeed became contaminated and thus posed a safety risk. For example, “studies in Brazil with PED-O-JET have shown that under field conditions the ejected vaccine was positive for occult blood by urine dipstick” (WHO, 1997)

1997 April
The Armed Forces Epidemiological Board made a site visit to the Marine Corp Recruit Depot at Parris Island and observed mass jet injections using Ped-O-Jet injectors. AFEB reported, “jet injector nozzle’s were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed.” 1999 AFEB – Report Citing Bloody Jet Injectors and Lack of Sterilization

1997 Nov. 20
As a direct result of the CDC and WHO conferences, Chairman and CEO, Fred Robinson, of Ped-O-Jet International notifies the Department of Defense by letter that due to safety concerns Ped-O-Jet injectors should no longer be used. “Until such studies conclude than [sic] no risk is present for blood borne disease transmission, we strongly urge the Armed Forces to discontinue use of the product,” wrote Mr. Robinson. Keystone Industries Withdrawal Letter

1997 Dec. 5
The DoD Medical Materiel Quality Control Program issues a product recall notice stating Ped-O-Jet injectors, both electrical and foot-pedal models, should no longer be used within the U.S. Armed Forces. 1997 Ft. Detrick statement

1997 Dec. 9
Defense Logistics Agency issues a memorandum declaring all jet injector devices, no matter the brand or model, be discontinued. “The use of these products, regardless of manufacturer, be discontinued until assurances of their safety are received. In light of the possible serious consequences and the letter from Ped-O-Jet, this is considered the best course of action. We are also suspending issue of these items from the depot.” 1997 (Dec 9) DoD – Defense Logistics Agency – Jet Hypodermic Injection Units copy

1998 Jan. 9
The Armed Forces Epidemiological Board issued a memorandum noting the risks of jet injectors and encouraged the use of newer technology jet injectors in which “the part of the device that comes into human skin contact is disposable.” Here the AFEB was referring to the Biojector 2000, which is a disposable cartridge jet injector.

AFEB further added “At those sites or situations where jet injectors are continuing to be used, A memorandum be issued, effective immediately, reviewing: 1) Proper device use and disinfection. 2) That standardized training in the above be completed by all persons using such devices.”

Also within this memorandum, the AFEB noted no active prospective surveillance studies have been performed to uphold the safety record of jet injectors. 1998 (Jan 9) AFEB- Recommendation on Jet Injectors

1998 April 15
The Armed Forces Epidemiological Board held the Infectious Disease Subcommittee Meeting in Norfolk, Virginia to discuss the safety of jet injectors. Dr. Bruce Weniger of CDC’s National Immunization Program gave an overview of jet injection and discussed safety issues (Weniger, 2013). The meeting was closed to the public “due to the fact that material of a proprietary nature” was being discussed (Federal Register, 1998).

1998 April 20
Navy Bureau of Medicine and Surgery updates its Immunization Requirements and Recommendations manual prohibiting the use of jet injectors. 1998 (April 20) DoD- BUMED 6230-incomplete version

1998 April 28
The AFEB encouraged the development of newer jet injection technology. (Multi-use nozzle jet injectors were initially designed by Walter Reed Army Institute of Research, so this was a call for the DoD to reinvent the technology). AFEB also recommended newly developed jet injector prototypes undergo testing to ensure the safety of patients. 1998 (Apr 28) AFEB- Recommendation on Jet Injectors

1998 April 29
The Secretary of the Navy implements an Anthrax Vaccination Program. The vaccination plan stated, “Jet injector immunization devices will not be used to administer anthrax vaccine.” 1998 (April 29) DoD- Anthrax Vaccination Implementation Plan

1998 Nov. 3
The DoD Medical Materiel Quality Control Program informs that Connaught Pharmaceutical was discontinuing large multi-dose vials of vaccines due to discontinuation of Ped-O-Jets. Connaught supplied yellow fever, meningococcal and tetanus-diphtheria vaccines. These vials “require[d] use of jet injector apparatus that is no longer recommended as an appropriate vaccination method.” 1998 (Nov 3) DoD MMQC-98-1248

BIOJECT_______________________________________________________________________________
1998 Nov. 25
Navy Bureau of Medicine and Surgery authorized the use of the Biojector 2000, a disposable-cartridge jet injector. “Biojector 2000 Injection Management System is authorized for use in Navy and Marine Corps activities for immunization, administration to service members and other beneficiaries. At this time, no other hypodermic jet injector system is FDA approved-this is required prior to consideration for BUMED authorization.” 1998 (Nov 25) Navy Bureau of Medicine DoD Memo

1999 March
Biojector Medical Technologies in conjunction with the U.S. Naval Research Center implemented a Phase I Human Trial upon military personnel. The trial administered a malaria DNA Vaccine with the Biojector 2000. This disposable-cartridge jet injector eliminates the risk of previous multi-use nozzle jet injectors (Bioject, 1999).

2003-2004
Between October 2003 and October 2004, the U.S. Military heavily used the Biojector 2000 to administer mass immunizations of recruits and within military hospital settings, as documented within the slide below.

Use of Biojector 2000 in US Military Oct. 2003 - Oct. 2004

 

Naval Ship Administering Injections with Biojector 2000

(Lynam, 2003)

Conclusion____________________________________________________________________________
As noted within the above DoD documents multi-use nozzle jet injectors were banned in 1998. Since then, any jet injector used within the Department of the Navy required FDA approval first. The only FDA approved jet injector during this time period was the Biojector 2000, a disposable cartridge jet injector.

Although protector cap needle-free jet injectors (PCNFI) underwent safety testing after 1998 there is no evidence to demonstrate PCNFIs were used within the military.

The true historical account of jet injectors demonstrates multi-use nozzle jet injectors were banned within DoD in 1998 and the vaccine vials for such devices were discontinued shortly thereafter. The fact that MUNJI devices were never used again demonstrates the seriousness and danger with which DoD viewed these devices. The fact that these documents were removed and destroyed at the earliest date by law demonstrates culpability on the part of U.S. Armed Forces.

 

References:

  • (Bioject, 1999) Bioject Medical Technologies, Inc. U.S. Navy Reports Positive Preliminary Results with Biojector(R) 2000 Device In Phase I Malaria DNA Vaccine Trial. PR Newswire. 21 December 1999. Available at: http://www.prnewswire.com/news-releases/us-navy-reports-positive-preliminary-results-with-biojectorr-2000-device-in-phase-i-malaria-dna-vaccine-trial-77728422.html.
  • (Federal Register, 1998) Federal Register. Department of the Army: Armed Forces Epidemiological Board. U.S. Government Printing Office. 13 April 1998; 63(70): 17995.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996.
  • (Lynam, 2003) Lynam K. Feedback From the Field: Needle-free Injection Use in Large Scale Immunization Campaign. Presentation at Innovative Administration Systems for Vaccines Conference. Rockville, MD. 18 December 2003.
  • (Weniger, 2013) Weniger BG. Curriculum Vitae. November 2013.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Analyzing CDC’s 1994 Conclusion

September 18, 2017

The Animal and Mathematical Models both demonstrated Ped-O-Jet injectors posed a risk in the transmission of blood-borne pathogens. The results also indicated wiping the nozzle only reduced and did not eliminate the risk. If the original design of this study were executed the results would have shown contamination of Hepatitis B surface antigen (HBsAg) in the internal fluid pathway, and that once the jet injector became contaminated it remained contaminated beyond the first shot and possibly beyond the second shot. Nonetheless, the evaluation showed sufficient levels of contamination for these CDC researchers to warrant restricted use of multi-use nozzle jet injector devices.

Grabowsky and colleagues recommended,

Jet injectors are most appropriate in emergency situations where mass vaccinations are required (e.g., meningitis outbreaks), in low HBV/HIV prevalence areas, or where other alternatives (e.g., disposable syringes) are unavailable or impractical. They should be avoided in some high risk groups or where proper cleaning and handling cannot be guaranteed. To reduce the risk of HBV or HIV transmission, the jet injector nozzle should be wiped after each injection with a rapidly drying agent (e.g., acetone). Use of a jet injector visibly contaminated with blood should be avoided (Grabowsky et al., 1994 [abstract]).

Grabowsky and colleagues openly admitted multi-use nozzle jet injectors (MUNJI) allowed the transfer of infectious pathogens between vaccinees and outlined what would be considered a low-risk circumstance when using a jet injector: Transmission would be considered low-risk when jet injectors are rarely used in emergency situations and amongst populations where the prevalence of blood-borne viruses (i.e., HBV, HCV & HIV) is low. Transmission would, therefore, be considered high-risk when MUNJIs are used repetitively amongst a population with a high prevalence of blood-borne pathogens, when nozzles are not wiped between vaccinees, and blood contamination upon the jet injector is disregarded.

MUNJI’s used within the military were used repetitively amongst an unscreened population. Military personnel were not screened for Hepatitis B, and Hepatitis C was not identified until 1989, although the virus has long existed. Therefore, there was no screening of military personnel for these viruses. Studies over the last twenty years have shown Vietnam-era and post-Vietnam era veterans have a higher prevalence of Hepatitis C than within the general population. The conditions of these veterans’ livers indicate they have had Hepatitis C for 30 to 40 plus years, dating back to the time of their military service. Archival footage has documented MUNJI nozzles were not wiped between vaccinees. Testimonies by thousands of veterans report the presence of blood upon the jet injector nozzle and at the injection site. These testimonies were later corroborated by an Armed Forces Epidemiological Board report which observed high-volume military jet injections and found “jet injector nozzle’s were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed” (Department of Defense, 1999). Therefore, based upon CDC’s analysis of what is considered low risk it can be inferred the high-volume jet injections once conducted upon military personnel were high-risk.

Within Grabowsky’s conclusion, he also gives a precise explanation for the lack of cases implicating the use of jet injectors. “The detection of rare, silent transmission would have been difficult, however, and likely to have been missed without active surveillance” (Grabowsky et al., 1994). Here Grabowsky notes blood-borne pathogens, such as Hepatitis B and Hepatitis C, most often progress asymptomatically. There are no observable signs or symptoms indicating a person is infected. Detection would only be confirmed through a blood test, in which case was not possible for Hepatitis C until 1992. Therefore a person infected with Hepatitis B or Hepatitis C by a jet injector would more than likely not show initial signs or symptoms due to the asymptomatic progression of these viruses.

Moreover, his point that detection of jet injector transmission would only be seen through active surveillance is paramount in understanding the lack of documented cases implicating jet injectors.

The necessity for active surveillance in detecting jet injector transmission was not a new concept within CDC. In 1977 CDC’s Hepatitis Laboratories Division called for “specifically designed prospective seroepidemiologic studies” to assess the risk of hepatitis transmission via jet injectors. Yet no one heeded the call; not even the CDC. Apparently, this recommendation had fallen upon deaf ears too infatuated with the speed and cost-efficiency of MUNJI devices.

 

Shedding Light Upon What CDC Thought of Jet Injectors
Often I have wondered what researchers within CDC actually thought of the risks associated with jet injectors. Did CDC view jet injectors as being only “theoretically” unsafe? Or did CDC view the risks associated with the Ped-O-Jet as real?

I reached-out to Dr. Mark Grabowsky, who is now retired, to help shed some light upon this third evaluation.

Dr. Grabowsky clarified his 1994 unpublished CDC study “was basically a literature review for internal CDC use looking at published data on jet injector safety.”

Below is part of our interview. As Dr. Grabowsky noted, these are only his “personal opinions and wild-ass-guesses without looking further into it.”

Q. How unsafe did CDC view these devices?

A. “We saw them as unacceptably unsafe,” stated Grabowsky. “It was because of the serum blowback and contamination of the tips of the devices. It was in the early days of HIV so we were all a little more worried. New devices with disposable tips or one-way valves were seen as more acceptable.”

Q. Throughout the 1990s the CDC warned of the risk of jet injectors transmitting Hepatitis B virus and HIV. Why didn’t the reports include the Hepatitis C virus? Personally, I always believed it was because the Hepatitis C virus was relatively new to medical professionals and still not understood very well but this is just my opinion.

A. “I think that is right.  We just never knew much about Hepatitis C at that time.  It was also really before the era of universal precautions so we were taking it on a disease by disease basis.”

Q. Do you think Hepatitis C could have been transmitted via jet injectors?

“I assume that if it was around it would have been transmitted.”

Q. Unequivocally, CDC has deemed multi-use nozzle jet injectors pose a risk in transferring blood-borne pathogens and has discouraged the use of these devices. Yet the agency has never recognized jet injectors as a risk factor for Hepatitis B, Hepatitis C, or HIV. Why do you think this is?

A. “At the time, I think it was because these types of injectors were being removed from use and so weren’t present as a risk factor.  But we certainly would have checked with the military and others who were using them.”

Q. Did CDC believe there was a lack of epidemiological evidence for listing jet injectors as a risk factor?

A. “I think the evidence was clear they were a risk – which is why the types of injectors were not in use.”

Q. Did CDC believe there was a lack of research for listing jet injectors as a risk factor?

A. “Probably lack of priority in identifying rare and hard to detect events that were going away anyway as jet injector use faded.”

 

As Dr. Grabowsky stated CDC viewed MUNJI devices as “unacceptably unsafe” due to serum blowback and contamination on the nozzle tips. In his professional opinion, he believes the Hepatitis C virus “would have been transmitted” via jet injection just like any other blood-borne pathogen.

What impact did the results of this third evaluation into jet injectors make? Join us in October, to read Impact of CDC’s 1993-94 Unpublished Study.

 

References:

  • (Department of Defense, 1999) Department of Defense. C. Issues of administration, 1. Jet injector use. In: Poland GA, (ed.). Vaccines in the Military: a Department of Defense-wide Review of Vaccine Policy and Practice. A Report for the Armed Forces Epidemiological Board, August 1999. Falls Church, VA: Infectious Diseases Control Subcommittee of the Armed Forces Epidemiological Board, 1999;60.
  • (Grabowsky et al., 1994) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes. Unpublished manuscript draft, dated January 3, 1994.
  • (Grabowsky et al., 1994 [abstract]) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes [abstract]. 1994.

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

CDC’s Animal and Mathematical Models

September 15, 2017

Animal Model
Grabowsky and colleagues utilized an animal model to assess the degree of contamination from a Ped-O-Jet injector. Two sets of in vitro tests were conducted to measure the frequency and volume of Hepatitis B surface antigen. The first test measured the degree of contamination when the gun was used according to the manufacturers recommendations. The second test measured the degree of contamination when the nozzle was wiped after administering an injection. These tests were similar to previous jet injector experiments conducted by CDC in 1977 and 1986, thanks in part to Walter Bond who served within all three experiments.

First Test
Within the first test, the researchers assessed whether after firing the Ped-O-Jet if the Hepatitis B surface antigen (HBsAg) would be sucked into the nozzle orifice and contaminate the next dosage. Detection of HBsAg would be indicative of Hepatitis B transmission.

For this experiment, the underside of a rabbit was shaved five days prior to testing. Upon the day of the experiment the rabbit was euthanized and 0.025 milliliters of HBsAg serum was placed upon the shaved skin of the rabbit. A sterile Ped-O-Jet administered a 0.5 milliliters injection to the now HBsAg-contaminated underbelly of the rabbit. Following the injection, the gun was held in place for 2 to 3 seconds, per manufacturer’s instructions. The Ped-O-Jet was then fired once into five separate 1 dram vials. The ejected fluid within each of the five vials was tested for HBsAg using Radioimmunoassay Ausria II. The test was repeated ten times creating a total of 50 samples. Every time the test was repeated the Ped-O-Jet was sterilized through autoclaving (Grabowsky et al., 1994).

The Ausria II Radioimmunoassay to detect Hepatitis B surface antigen was the same radioimmunoassay used within the 1977 investigation. It remains unclear why the researchers did not use newer, more sensitive radioimmunoassays able to detect far lower levels of HBsAg. The fact that Ausria II was used again was likely the decision of Walter Bond who served within both investigations of the Ped-O-Jet.

Nonetheless, the results found the ejected fluid of the next shot fired was positive for HBsAg in 19 out of 50 (38%) of the samples. Within these contaminated samples, the average volume of blood detected in the ejectate was 0.118 microliters (range, 0.023 uL – 0.417 uL) (Grabowsky et al., 1994). The exterior nozzle of the Ped-O-Jet was positive for HBsAg in 8 out of 10 (80%) of the samples. Yet the interior of the nozzle was negative (0 out of 10) for HBsAg contamination (Weniger, 2003). This data demonstrated significant contamination.

To put this into perspective, lets convert these figures into picoliters which is the smallest estimated unit for transferring blood-borne pathogens. One microliter equals 1,000,000 picoliters. The estimated volume of blood to transfer the Hepatitis B Virus is 10 picoliters and the estimated volume of blood to transfer the Hepatitis C Virus is 100 picoliters.

Therefore, the contaminated 19 samples of ejected fluid converts to 23,000 to 417,000 picoliters of blood, with the average volume of blood being 118,000 picoliters. This means these samples could hold 2,300 to 41,700 Hepatitis B virions and 230 to 4,170 Hepatitis C virions. With the averages being 11,800 Hepatitis B virions and 1,180 Hepatitis C virions. This data demonstrates blood-borne pathogens could have been transferred through the ejectate fluid of a Ped-O-Jet injector.

Second Test
In a second set of tests, the researchers assessed whether wiping the nozzle reduced or prevented cross-contamination between jet injections. The nozzle of the Ped-O-Jet was wiped with a cotton ball moistened in acetone immediately after inoculating the underside of a rabbit contaminated with 0.025 milliliters HBsAg serum. The Ped-O-Jet was then fired five times into five separate 1 dram vials. The ejectate fluid in each of the vials was assayed. This test was repeated ten times (Grabowsky et al., 1994).

Results found the ejected fluid of the next shot fired was positive for HBsAg in 3 out of 50 (6%) of the samples. Within these contaminated samples, the average volume of blood detected in the ejectate was 0.016 microliters (range, 0.01 uL – 0.022 uL) (Grabowsky et al., 1994). The exterior nozzle of the Ped-O-Jet was positive for HBsAg in 3 out of 10 (30%) of the samples. While the interior of the nozzle was again negative (0 out of 10) for HBsAg contamination (Weniger, 2003).

To put this into perspective, the contaminated 3 samples of ejected fluid converts to 10,000 to 22,000 picoliters of blood, with the average volume of blood being 16,000 picoliters. This means these samples could hold 1,000 to 2,200 Hepatitis B virions and 100 to 220 Hepatitis C virions. With the averages being 1,600 Hepatitis B virions and 160 Hepatitis C virions. The data demonstrates wiping the nozzle of the Ped-O-Jet reduced but did not eliminate contamination, and thus blood-borne pathogens could still have been transferred.

Limitations of Study
In reviewing this study, it came to the attention of this author that the researchers had failed to collect all of the data as planned within the original design of their study. After artificially contaminating the Ped-O-Jet, the gun was to be “shot” five consecutive times, each time into a 1 dram vial so the ejectate of the “shot” could be collected and assayed. Therefore the first “shot,” represents the first injection given after the jet injector became contaminated. The second, third, fourth and fifth shots represent the second, third, fourth and fifth persons to receive an injection after the jet injector became contaminated. This test was repeated ten times; thus creating 50 samples. However, Grabowsky and colleagues failed to assess and report how many of the HBsAg-positive samples were from the first shot, how many from the second shot, how many from the third shot, and so forth. The graph below demonstrates how the test should have been conducted. This data would be important in identifying how long the Ped-O-Jet remain contaminated, as was done within CDC’s 1977 evaluation.

Recommended Graph

For instance, in the first test 19 of the 50 samples were HBsAg-positive indicating that more than just the first shots were contaminated. We can presume that all ten of the first shots were positive and therefore either nine of the second shots tested were positive or eight of the second shots and one of the third shots were positive, etc. This information would have been very beneficial for assessing the degree of contamination.

Moreover, the data indicating the interior of the nozzle was negative for HBsAg contamination zero out of ten times is misleading. The experiment was repeated ten times. Therefore it can be assumed that the interior nozzle was only tested in each of the ten experiments after firing the fifth shot into the vial. Yet, as CDC’s 1977 experiment found, once the Ped-O-Jet became contaminated it remained contaminated for the following two consecutive shots. So the researchers should have analyzed within a third set of tests how many of the samples would be positive for HBsAg if the interior of the nozzle was tested after the first or second shots. Based upon the design of their study, they only assessed if the jet injector was still contaminated after firing five shots. The researchers failed to assess the risk to the next person in line once the jet injector became contaminated.

 

Mathematical Model
Grabowsky and colleagues (1994) also assessed the risk of blood-borne disease transmission via jet injectors and needle stick injuries by implementing a mathematical model. This equation is being thoroughly analyzed and scrutinized and will be reported upon at a later date.

From the Animal and Mathematical Models Grabowsky and colleagues summarized their findings. Join us Monday, September 18th to read Analyzing CDC’s 1994 Conclusion.

References:

  • (Grabowsky et al., 1994) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes. Unpublished manuscript draft, dated January 3, 1994.
  • (Weniger, 2003) Weniger BG. Jet Injection of Vaccines: Overview and challenges for mass vaccination with jet injectors. Innovative Administration Systems for Vaccines (conference). Rockville, Maryland, USA, 18-19 December 2003.

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Part 3 – CDC Retests the Safety of Jet Injectors in 1993-94

September 12, 2017

 

In 1993, the Center for Disease Control and Prevention (CDC) retested the safety of the most widely-used jet injector—the Ped-O-Jet. The investigation was the agency’s second evaluation into Ped-O-Jet, and third overall evaluation of jet injector devices.

The ongoing investigation into jet guns was prompted by two circumstances: 1) An increased awareness of HIV and viral hepatitis, which had caused a growing fear of virus transmission within the medical community at the time; and 2) Two previous CDC investigations (i.e., 1977 and 1986) failed to demonstrate jet injectors were risk free.

“As part of an ongoing epidemiologic investigation of HBV [Hepatitis B] transmission involving use of a jet injector,” wrote lead CDC researcher Dr. Mark Grabowsky in an unpublished study, “we conducted comparative laboratory studies to examine the potential risk of the transmission of bloodborne viruses should the injector become contaminated” (Grabowsky et al., 1994). The findings, although never published, were not kept a secret and an abstract was made known to the public in the Spring of 1994.

 

Jet Infectors - CDC's 1994 Study

 

Amongst Grabowsky’s team were: Epidemiologists, Dr. Stephen Hadler and Dr. Robert Chen, from CDC’s National Immunization Program; microbiologist, Walter Bond from CDC’s Hospital Infections Program; and epidemiologist Dr. Glaucus de Souza Brito from the Brazilian Ministry of Health.

Many of researchers had previous experience in assessing the safety of jet injectors. Dr. Hadler was a part of CDC’s evaluation of the Med-E-Jet in 1986. Dr. de Souza Brito had extensively used and tested the Ped-O-Jet in Brazil. Most interestingly though, Mr. Bond had been involved within all three of CDC’s safety testing of jet injectors.

Purpose
In this third evaluation CDC sought “to estimate the risk of bloodborne disease transmission from a jet injector” and to determine if swabbing the Ped-O-Jet injector nozzle had an effect on reducing the risk of transmission (Grabowsky et al., 1994).

It is important to note a major shift in the rhetoric by CDC. As noted above, the CDC stated its purpose was to assess the “risk of bloodborne disease transmission from a jet injector” (Grabowsky et al., 1994). However, four-years prior, CDC researchers Canter and colleagues (1990), recommended “training in the use of jet injectors, and care in cleaning and disinfection procedures to ensure the continued safe use of these instruments” (Canter et al., 1990). Within a time period of four-years, the CDC went from “the continued safe use” of jet injectors to estimating the “risk of bloodborne disease transmission from a jet injector.”

 

Overview of Study
Unequivocally, CDC knew jet injectors could act as vehicles in the transfer of pathogens. CDC also knew these devices posed a risk especially amongst highly infectious viruses. “It was estimated that viruses that circulate in high titers in blood, such as HBV (10x-8/mL) and LDH virus (10x-7/mL), could be transferred during a procedure if the jet injector were contaminated during use,” stated Grabowsky in reviewing CDC’s 1986 investigation of the Med-E-Jet (Grabowsky et al., 1994).

The time had come to assess how much of a risk the Ped-O-Jet posed. Grabowsky and colleagues used two methods to assess this risk: an Animal Model and a Mathematical Model.

What did Grabowsky’s investigation reveal? CDC’s Animal and Mathematical Models

References:

  • (Canter et al., 1990) Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan JM. An outbreak of hepatitis B associated with jet injections in a weight reduction clinic. Arch Intern Med. 1990 Sep; 150(9):1923-7.
  • (Grabowsky et al., 1994) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes. Unpublished manuscript draft, dated January 3, 1994.

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Military Footage Captured Recruit Jet Injector Vaccinations

Archival military footage has captured soldiers receiving mass jet injections with Ped-O-Jet injectors. These films demonstrate soldiers being inoculated consecutively, one after another, in an assembly-line formation. These films also captured nozzles were never wiped between patients. Therefore any contamination upon the nozzle was transferred to the next person in line.

These clips corroborate the testimonies of veterans who witnessed blood dripping from the injection site, improper vaccination procedures by corpsmen, and failure to wipe to nozzle between soldiers.

 

1963 Army Training Center


This footage captured blood dripping down the arm of the recruit within the mass jet injection line.

 

1967 Army Training Center – Fort Jackson

 

1989 Army Training Center – Fort Jackson

 

1989-1990 Army Training Center – Fort Sill

This footage captured a corpsmen disregarding vaccination protocol by having a jet injector in each hand. Proper procedure states the vaccinator must support the patient’s arm while the vaccination is given. The flesh must be pulled tightly. Failure to administer proper vaccinations “will injure the recipient’s skin and will fail to deliver the required dosage of vaccine” (Army Medical Handbook of Basic Nursing, 1970).

 

1990s Navy Jet Injections

 

1995 Army Training Center – Fort Sill

 

Reference:

  • (Army Medical Department Handbook of Basic Nursing, 1970) Army Medical Department Handbook of Basic Nursing. Jet Hypodermic Injection Apparatus, Automatic. Department of the Army. November 1970. pp. 395-398.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Impact of the 1985 Outbreak

For the past thirty-one years, the CDC led the public to believe that the 1986 report was the agency’s first investigation into jet injectors. The CDC assured that this outbreak was only due to the particular nozzle design of the Med-E-Jet and that all other jet injectors were safe. Omitted from any discussion or report was the fact that the agency had conducted safety testing of the Ped-O-Jet nine-years prior and found transmission was possible. Regardless of the 1985 outbreak, the CDC continued to use multi-use nozzle jet injectors.

Within the Department of Defense, the outbreak prompted the Armed Forces Epidemiological Board (AFEB) to discuss the risks of jet guns in a June 1986 meeting. The AFEB is an expert advisory board of civilian physicians and scientists that assists the Department of Defense with medically related issues. The AFEB even discussed the possibility of HIV being transmitted when jet injectors administer biological products, such as gamma globulin. However, the committee was reluctant to impose any changes in June of 1986 (Woodward, 1990). By 1987 the AFEB finally recommended the Med-E-Jet be banned within the Armed Forces and be removed from the Federal Stock System (Nikolewski & Wells, 1989). In March of 1988, the AFEB gave the recommendation “that the jet injector gun be used only with authorized military technical parts and that it be sterilized according to standard procedures” (Woodward, 1990). Yet despite this latter recommendation the Armed Forces continued to use jet injectors haphazardly. Military footage and a subsequent AFEB report in 1999 document the military’s disregard for abiding standard procedures and set protocols for sterilization.

Outside of the United States, the 1985 outbreak elicited a far different response. For many the outbreak served as proof that all multi-use nozzle jet injectors were unsafe and served as a catalyst for change.

In September of 1986, a Dutch committee on immunization opined that jet guns should no longer be used in the Netherlands (Bijkerk, 1986). The decision stemmed not only from the 1985 U.S. outbreak but also from a Dutch study by Brink and colleagues (1985) which demonstrated virus transmission from the use of jet guns.

By October of 1986, the World Health Organization (WHO) changed its policy on jet injector usage. WHO’s highly publicized statement said,

Until further studies clarify the risks of disease transmission with different types of jet injectors, their use should be restricted to special circumstances where the use of needles and syringes is not feasible because of the large numbers of persons to be immunized within a short period of time (WHO, 1986).

This change restricted the use of jet injectors to dire situations only.

By 1989, both UNICEF and WHO recommended establishing stricter safety guidelines for jet injectors. One recommendation addressed correcting an inherent problem with jet injectors. “[The] manufacturer must provide evidence that there shall be no reflux of external fluid into the fluid path way after repeated injections,” stated the report (UNICEF/WHO, 1989). Herein UNICEF and WHO identified the inherent problem of fluid suck-back and the risk of virus transmission this posed. It is important to note, fluid suck-back was observed in CDC’s 1977 investigation of the Ped-O-Jet and in CDC’s 1986 investigation of the Med-E-Jet.

As part of an ongoing investigation, the CDC reevaluated the safety of a multi-use nozzle jet injector in the early 1990s. This was the agency’s third investigation into the safety of the devices. Find out what they found – Part 3 – CDC Retests the Safety of Jet Injectors in 1993-94.

 

References:

  • (Bijkerk, 1986) Bijkerk H. Het risico van ziekte-overdracht via een inentingspistool bestaat. [Risk of Disease Transmission Via Jet Gun Injection is Real]. Ned Tijdschr Geneeskd. 1986 Nov 8;130(45):2050. [article in Dutch]
  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (Nikolewski & Wells, 1989) Nikolewski RR & Wells RA. “Appendix 3: A List of the Board’s Recommendations from 1955 through 1989.” The Armed Forces Epidemiological Board: It’s First Fifty Years. Available online: http://history.amedd.army.mil/booksdocs/itsfirst50yrs/appendices.html.
  • (UNICEF/WHO, 1989) UNICEF/WHO. Criteria for low-workload jet injectors: May 11, 1989, J. Bish UNICEF and RH Henderson, WHO/EPI.
  • (VBA Fast Letter 211 (04-13)) VBA Fast Letter 211 (04-13). Relationship Between Immunization with Jet Injectors and Hepatitis C Infection as it Relates to Service Connection, Veterans Benefit Admin. (VBA) Fast Letter No. 04-13, 211 (April 29, 2004).
  • (WHO, 1986) WHO/EPI. WHO/UNICEF Joint Guidelines. Selection of Injection Equipment for the Expanded Programme on Immunization. 1986. WHO/UNICEF/EPI.T5/ 86.27597.
  • (Woodward, 1990) Woodward TE. The Armed Forces Epidemiological Board: Its first fifty years. Center of Excellence in Military Medical Research and Education. 1990.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Military Jet Gun Injections Transmitted Hepatitis: an assessment of VA claims from 1992 – 2016

 

Updated: June 26, 2017

In an August 2004 Internet post titled, Hepatitis C: Military-Related Blood Exposures, Risk Factors, VA Care, the Department of Veterans Affairs purported, “Although there have been no case reports of hepatitis C being transmitted by a jet gun injection, it is biologically plausible.”

To date the biologically plausible, or rather theoretically possible yet improbable response, has been the VA’s stance on this issue.

However, in spite of the VA’s longstanding statement, a department within the agency is finding otherwise. Within recent years the Board of Veterans Appeals (BVA), an informal court within the VA, has received an influx of jet injector cases. Veterans, lacking the more typical risk factors, are recognizing the jet injector as the only causality for his and her hepatitis C. The court’s recognition of these nexuses in a substantial number of cases debunks the possibility as being “only theoretical” and instead establishes the possibility as not only plausible but probable.

A review of case law from 1992 to 2016 found the Board of Veterans’ Appeals had ruled upon 1,705 cases that cited the jet injector. From these cases 139 were granted, 843 were denied, 653 were remanded back to the VA Regional Office to seek another medical opinion, and 70 cases were granted but needed to be excluded from the rest of the data because either the judicial rendering did not mention the jet injector, the judicial rendering specifically excluded the jet injector, or the veteran’s symptoms of hepatitis C were documented inservice and therefore service-connection was automatically granted and an etiological cause was unneeded.

The graph below demonstrates trends overtime concerning jet injector cases that were decided by Veteran Law Judges.

 

BVA Jet Injector Cases 1993 - 2016 - 1BVA Jet Injector Cases 1993 - 2016 - 2BVA Jet Injector Cases 1993 - 2016 - 3

From 2003 to 2008 there was a surge of jet injector decisions, most of which were denied. Despite the fact that these cases were denied, a significant number of these cases should have been granted as the Veterans Law Judge failed to appropriately recognize the jet injector as a risk factor and failed to appropriately apply the Benefit of Doubt Law (38 U.S.C.S. § 5107(b)) or the analogous Reasonable Doubt Law (38 C.F.R. § 3.102). When the positive and negative evidence of a case is in equipoise (equal to each other), the benefit of the doubt always goes to the veteran. The veteran prevails and the case is granted. (More will be discussed on this in a future blog post).

Since 2008 there has been a surge in remanded decisions. Meaning the Veteran Law Judges are remanding the case, or rather sending the case back, to the VA Regional Office (VARO), with specific instructions mandated by the BVA court. Usually remanded cases sent back request the VARO to seek another medical evaluation of the veterans’ claim file.

Most remarkably granted cases have been on a slow but gradual incline. In 2016, the BVA granted more jet injector claims than ever, granting a total of 21 claims.

The 139 cases that were granted can be further broken-down into separate categories. [The categories below are slightly different from previous articles.] Out of these:
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:

  • 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.
  • In 10 of these 47 cases, either the veteran or the VA cited possible other causes for HCV which were in fact not actual risk factors, leaving the jet injector as the only actual risk.
  • 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.

2.  In 20 cases, veterans’ military jet injections were found to be in equipoise, that is equal to, to other non-service risk factors.
3.  One case explicitly rendered that the jet injector was the etiological cause of the veteran’s hepatitis B infection.
4.  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.
5.  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
6.  One case found the jet injector caused an adverse condition in a veteran’s upper arm.

 

Here is a listing to the case citations to all granted jet injector cases.

 

Therefore the statement, “Although there have been no case reports of hepatitis C being transmitted by a jet gun injection” is an outright lie. Numerous cases have cited this nexus. These cases were not granted out of sympathy. Oh contrar! Let’s look at the weighing of evidence.

The nexus between military jet injections and veterans’ hepatitis C was cited explicitly in 47 cases. Amongst these cases the evidence was weighed in—

  • 41 cases as “at least as likely or not” and “likely as not,” meaning there is at least a 50 percent likelihood. (Listing of these 41 Citations)
  • 3 cases as “more likely than not,” or rather a greater than 50 percent likelihood. (see cases Citation # 0945788, # 1525003 and # 1628702).
  • 3 cases as “due to,” or rather 100 percent related. (see cases Citation # 0531165, # 0724695 and # 1553509).

 

The number of cases backlogged and awaiting decisions remains unknown. There are jet injector/hepatitis C cases that have been granted within the VA Regional Office level, however these findings are not published and therefore unknown (personally I am only aware of four such cases).

 

So why is this article important?

BVA cases are nonprecedential. The outcome of one BVA claim has no legal bearing in other claims.

Although this is true, VA Regulation also states, providing that “[p]rior decisions in other appeals may be considered in a case to the extent that they reasonably relate to the case” (38 C.F.R. § 20.1303). Therefore, to establish jet injectors as risk factors for HCV in your claim the following cases cited above will “reasonably relate.” Although no precedent has been set, the Court, acting as one collective body, will have to show “consistency in issuing its decisions” (38 C.F.R. § 20.1303).

 

How to Structure A Jet Injector Claim

© Shaun Brown and Jet Infectors, 2014-2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Part 2 – CDC Retests the Safety of Jet Injectors in 1986

June 19, 2017

“Hepatitis Outbreak Laid to Contaminated Jet Injection Gun,” read the headline of the June 13th, 1986 edition of the LA Times (Maugh, 1986).  Between 1985 and 1986, the CDC thoroughly investigated a Hepatitis B outbreak caused by a jet injector at a LA weight reduction clinic.

Assessing the Outbreak
The weight reduction clinic in Long Beach was administering regular injections of human chorionic gonadotropin (HCG) to its patients via a Med-E-Jet injector and by syringe and needle at the time the outbreak was identified by local health officials.

Analyses by CDC found twenty-one percent (60/287) of those attending the clinic had an acute infection of Hepatitis B.  Twenty-seven individuals were infected with Hepatitis B and another thirty-three individuals were IgM positive meaning each had the antibody to hepatitis B core antigen (Canter et al., 1990; CDC,1986).  For a person to test IgM positive is indicative that he or she was infected with the hepatitis B virus within the last 6-months.  Two individuals identified with Hepatitis B were found to have other risk factors for acquiring Hepatitis B virus within the previous six-months (CDC, 1986).  Therefore, two individuals already infected with Hepatitis B were identified amongst the cohort receiving jet injections and were likely the culprits who unknowingly infected the others.

Amongst those individuals who exclusively received HCG by jet injection, twenty-four percent (57/239) had developed an acute Hepatitis B virus infection.  Interestingly, the 22 patients who received injections exclusively by a syringe never acquired the hepatitis B virus (CDC, 1986; Canter et al., 1990).  This data indicates that a total of 57 individuals had evidence of acute infection with hepatitis B virus as the result of receiving injections with a multi-use nozzle jet injector.

“Everyone always assumed that jet guns were safe,” said Dr. Steve Hadler, Chief of Epidemiology Activity within CDC’s Hepatitis Branch, in a newspaper article (Hendrick, 1986).

CDC’s assessment of the outbreak found 57 individuals had been infected from receiving injections with a jet injector.  Throughout the years, the Department of Veterans Affairs (VA) has grossly minimized this outbreak. VA states, “there is at least one case report of hepatitis B being transmitted by an airgun injection” (VBA Fast Letter 211 (04-13)).  A case report is defined as a detailed report listing the signs, symptoms, diagnosis and treatment of an individual patient.  Therefore, contrary to VA’s reporting, there are in actuality 57 documented cases, or rather 57 cases reports, of Hepatitis B being transmitted by jet injection.

The outbreak prompted CDC to retest the safety of jet injectors.

 

CDC’s Laboratory Investigations
“Five Med-E-Jet injectors used in these weight reduction clinics were sent to the Centers for Disease Control, Atlanta, Ga, for further evaluation,” stated a report by the researchers (Canter et al., 1990).

CDC’s 1986 investigations evaluated the threat of cross-contamination of blood-borne pathogens when using a Med-E-Jet injector.  The researchers explained their 1986 investigations within a medical journal.  “A series of in vitro and in vivo laboratory experiments were carried out to assess the potential for a contaminated Med-E-Jet to transmit HBV from patient to patient and to assess the potential for HBsAg contamination of this jet injector during actual use,” stated the article (Canter et al., 1990).  Within these experiments detection of the Hepatitis B surface antigen (HBsAg) would be presumptive evidence of Hepatitis B contamination.

Analysis of the outbreak and investigations of the Med-E-Jet were published twice; once within a 1986 CDC report and again in a 1990 medical journal.  It is interesting to also note that CDC microbiologist Walter Bond, who was a part of the 1977 investigations of the Ped-O-Jet, was also a part of the 1986 laboratory investigations of the Med-E-Jet in Atlanta.

 

Firing Into Vials – In Vitro Experiments
Several in vitro tests were implemented to assess the frequency of contamination when using the Med-E-Jet.  Within the first experiment, the Med-E-Jet nozzle was artificially contaminated with Hepatitis B surface antigen (HBsAg) to see if the antigen would be sucked back into the nozzle head and contaminate the next dosage to be fired.
Results found, after the nozzle was contaminated, the ejected fluid of the next shot fired was positive for HBsAg in 40 out of 50 (80%) of the samples.  Med-E-Jet surfaces were also tested for contamination.  Results showed HBsAg contamination upon the exterior of the nozzle in 9 out of 10 (90%) of the samples.  Samples from within the nozzle interior were HBsAg-positive in 8 out of 10 (80%) occurrences.  The nozzle tip was HBsAg-positive in 9 out of 10 (90%) of the samples (Weniger, 2003).  This data demonstrated gross contamination of the Med-E-Jet due to fluid suck-back.

In a second set of experiments, researchers assessed if wiping the nozzle between consecutive patients would remove any contamination from the nozzle surface.  Using a cotton ball moistened in acetone researchers wiped the contaminated Med-E-Jet nozzle to see if the HBsAg would be reduced or eliminated.

The results after wiping the nozzle found the ejected fluid of the next shot fired was positive for HBsAg in 29 out of 45 (64%) of the samples.  Results of Med-E-Jet surfaces were positive for HBsAg in 7 out of 9 (78%) of the samples from the nozzle exterior, 5 out of 9 (56%) of the samples from the nozzle interior, and 6 out of 9 (67%) of the samples from the nozzle tip.  This data indicated wiping the Med-E-Jet with acetone after each injection did not significantly reduce the frequency of HBsAg contamination (Weniger, 2003).

 

Jet Injecting Chimpanzees – In Vivo Experiments
In this in vivo experiment the CDC assessed if the Med-E-Jet would become contaminated with Hepatitis B surface antigen after injecting a chimpanzee infected with the pathogen.  Immediately following the injection the next shot to be delivered was fired into a vial and tested for blood and HBsAg.  This test was repeated five times.

Results could not detect HBsAg in the ejected fluid in any of the five injections with the Med-E-Jet.  The researchers, however, did state, “Bleeding did occur at the four of the five injection sites, even though injections were carefully done according to the manufacturer’s recommendation” (Canter et al., 1990).

Despite these findings it is duly noted that the exact Med-E-Jet injectors documented in the 1985 Hepatitis B outbreak of 57 individuals did not demonstrate such cross-contamination when tested upon a chimpanzee.  This finding calls into question the validity of relying upon chimpanzee studies to assess the safety of jet injectors.  It appears, in this regard, comparing humans to chimpanzees is like comparing apples to oranges.

Possibly the assay used by CDC within their laboratory investigations was not able to detect HBsAg.  The report did not specifically mention which assay product was used within the laboratory investigations.  Although it was noted that within the investigation of the outbreak serum specimens of those attending the Long Beach clinic were evaluated using Auszyme by Abbott Laboratories (Canter et al., 1990).  Assuming the assays were the same for both procedures would call into question the validity of the animal model used.  If the assays were different it would call into question the capability of the assay used within the laboratories investigation to detect low levels of HBsAg.

 

Summary of Findings
In 1986, the CDC investigated the Med-E-Jet in a laboratory setting to assess the degree of contamination caused by this particular model of device.  The official 1986 report stated,

the estimated volume of contaminating material transferred in downstream injections was 0.53 micro liters (0.53 x 10–3ml).  Therefore, it can be estimated that viruses that circulate in high titers in blood, such as HBV (10-8/ml) and LDH virus (10-7/ml), could be transferred during a procedure if gun contamination occurred.  The probability of transferring microorganisms present in lower concentration ( < 10-3/ml) would be correspondingly lower (CDC, 1986).

Herein the CDC recognizes highly infectious viruses can be transferred via jet injection.

Canter and colleagues (1990) concluded, “This epidemiologic and laboratory investigation suggests that when this model of jet injector [Med-E-Jet] becomes contaminated with blood, transmission of HBV can occur” (Canter et al., 1990).

 

References:

  • (Canter et al., 1990) Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan JM. An outbreak of hepatitis B associated with jet injections in a weight reduction clinic. Arch Intern Med. 1990 Sep; 150(9):1923-7. 
  • (CDC, 1986) Centers of Disease Control. Epidemiologic Notes and Reports Hepatitis B Associated with Jet Gun Injection — California. MMWR 1986;35(23):373-376.
  • (Hendrick, 1986) Hendrick O. Jet gun injector causes hepatitis outbreak. United Press International 12 June 1986. Accessed at: http://www.upi.com/Archives/1986/06/12/Jet-gun-injector-causes-hepatitis-outbreak/5885518932800/.
  • (Maugh, 1986) Maugh TH. Hepatitis outbreak laid to contaminated jet injection gun. Los Angeles Times. 13 June 1986. Accessed at: http://articles.latimes.com/1986-06-13/news/mn-10799_1_jet-injector.
  • (VBA Fast Letter 211 (04-13)) VBA Fast Letter 211 (04-13). Relationship Between Immunization with Jet Injectors and Hepatitis C Infection as it Relates to Service Connection, Veterans Benefit Admin. (VBA) Fast Letter No. 04-13, 211 (April 29, 2004).
  • (Weniger, 2003) Weniger BG. Jet Injection of Vaccines: Overview and challenges for mass vaccination with jet injectors. Innovative Administration Systems for Vaccines (conference). Rockville, Maryland, USA, 18-19 December 2003.

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

 

 

December of 1977 Summary

June 13, 2017

The Special Investigations Section summarized it’s findings of the Ped-O-Jet by stating,

Although there is a lack of epidemiologic data implicating jet injector guns in the transmission of viral hepatitis B, we feel that the remote possibility of transmission would be increased by improper use of the gun.  For example, our in vitro studies showed that a massively contaminated nozzle was capable of contaminating the injected fluid for at least two subsequent shots; if the gun was not properly pressed on a patient’s arm during injection and the skin was torn, it is conceivable that such massive contamination may occur in an in-use situation.  We did not demonstrate such carry-over of HBsAg in our in vivo studies, but these experiments were not designed to simulate a worst-case condition as described.  A more definitive statement regarding the safety of jet injector guns with regard to hepatitis B transmission is dependent upon specifically designed prospective seroepidemiologic studies.

The irony of the situation is befitting—the location where the CDC secretly requested epidemiological evidence to further assess the risk of jet injectors was thirty-years later turned over to a government agency that serves precisely the population who was most impacted by jet injectors—military veterans.

Veterans have long blamed jet injectors as one of the sources for the high prevalence of Hepatitis C amongst the now older veteran population.  Jet guns were widely used within the military to deliver numerous immunizations until being banned in 1998.  The VA acknowledges the nexus as “biologically plausible” but to date refuses to recognize jet guns as an official risk factor.

In light of this report, the true historical account of jet injectors demonstrates the Ped-O-Jet came under investigation by the CDC in 1977 from the presence of blood during mass vaccination campaigns.  The full details of the report by the Hepatitis Laboratories Division demonstrated the possibility of transmission of blood and viral hepatitis.  The report signified concern, not relief, over the device.

The researchers did note the lack of epidemiological data implicating the devices.  That is to say there was a lack of any known outbreaks due to jet injectors.  However, this was an illogical point even for that time period.  Knowledge of the asymptomatic progression of serum hepatitis and the recognition of a new hepatitis virus, called non-A, non-B Hepatitis were known throughout the mid- to late-70s and should have brought heightened awareness and the exercising of precautionary measures.

Development of more precise Hepatitis B assays have made detection of low levels of Hepatitis B surface antigen possible.  DNA hybridization, for instance, can detect Hepatitis B surface antigen in solutions 1,000 times smaller than within the method used by the Special Investigations Section.  Therefore, based upon the methods used by the Special Investigations Section, it is highly possible that transmission could have occurred and gone undetected within their experiments.

The final conclusion by the Hepatitis Laboratories Division suggested further studies be implemented.

 

More Questions Than Answers
After reading this report more questions than answers arose.  For instance, what did Deputy Director of the Hepatitis Laboratories Division, Martin Favero, do upon receiving the report in December of 1977?  Did he pass the report along to CDC Headquarters in Atlanta?  Did he wish to implement another study?  Was he going to inform the manufacturer of the Ped-O-Jet of the test results?  Or did he assume the responsibility now befell upon others to create seroeopidemiological studies?

Attempts to reach out to Mr. Favero were made.  Although, he had asked Norman Petersen, the lead investigator of this study, to speak on his behalf.

Former Chief Norman Petersen explained in a recent communication,

The report you cite was a routine quarterly report that was submitted by the Special Investigations Section to Dr. Favero as a means of documenting the work done in the past quarter.  These reports were widely distributed to an established list of interested readers as well as to the CDC chain of command in Atlanta.

Petersen added, “While it has been 40 years since the writing of the report, I do not recall that the findings resulted in further investigations by our group.  At the time we, and CDC in general, were more interested in whether jet injectors were found to be a significant risk factor in the transmission of hepatitis B in seroepidemiologic studies involving real-life activities.”

The question arises, how does a lab inquire about the possibility of Hepatitis B transmission via jet injectors, discovers transmission is possible and then does nothing afterwards?  Secondly wouldn’t the possibility of transmission demonstrated within the in vitro experiments prompt the lab to inquire about the degree of transmission under worst case scenarios?

The CDC unequivocally acknowledged the jet gun risk in 1977 but viewed the benefits of these devices as a tool for mass immunizations outweighed the risk of transmission.

Mr. Petersen said so himself.  “Although the observed risk of contamination of jet injectors is recognized, the risk-benefit ratio of their use in mass immunization programs is an equally important public health factor.”

CDC’s decision in 1977 to disregard transmission via jet injectors is shocking and disheartening.  Although this report was disseminated within CDC and to a limited number of researchers, it was never made known to the general public.  Thus the public was never given informed consent on the risks of receiving immunizations with such devices or the option of whether or not to partake in this method of vaccination.  An agency solely established to protect the health of its citizenry should not have gambled on whether an outbreak would arise from jet injectors.

In 1985 an outbreak did arise and the CDC was called upon to retest the safety of jet injector devices.   Next Article – Part 2 – CDC Retests the Safety of Jet Injectors in 1986

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Jake The Chimpanzee – In Vivo Experiments

June 9, 2017

Petersen, Bond and Carson then conducted a series of tests to assess if the Ped-O-Jet would become contaminated after injecting an animal already infected with hepatitis B surface antigen (HBsAg).  Two male chimpanzees were used: Jake an adult chimpanzee weighing 145 pounds and a juvenile chimpanzee (name unknown) weighing 44 pounds.  Both chimps were sedated with ketamine for the experiment.

In this in vivo experiment—an experiment taking place in a living organism—a 0.5 ml sterile saline injection was given with a sterile Ped-O-Jet to the HBsAg-positive chimpanzees.  The Ped-O-Jet was firmly held against the skin during the administration of the injection and for three-seconds after the injection.  Following the injection the Ped-O-Jet was fired into a vial and the ejected fluid tested.  If the fluid was HBsAg-positive it would implicate the jet injector as a vehicle in the cross-contamination of viral hepatitis.

Jet Infectors - Phoenix Field Station In Vivo study

Special Investigations Team testing a Ped-O-Jet injector on a chimp in 1977

Detection of blood and HBsAg were obtained using methods viable in 1977 and which are no longer relied upon.  Nonetheless, the results from the in vivo experiments were inconsistent.  For Jake, the adult chimpanzee, one sample from the injection site tested positive for occult blood by Hemastix (urine dipstick) and positive for HBsAg by radioimmunoassay (RIA) using Ausria II, while the remaining four injection site samples were negative.  For the juvenile chimp, 4 out of 5 injection sites were positive for occult blood but all five were negative for HBsAg.  The Ped-O-Jet was swabbed but all samples were negative for HBsAg.  Results of the ejected fluid, the most critical test within the experiment, were also all negative for HBsAg.

The researchers concluded, “from these in vivo experiments that jet injector nozzle surfaces and interior surfaces of the gun are apparently not easily contaminated during actual use.”  The researchers further stated, this experiment only tested conditions under normal use and did not represent a “worse-case condition.”

Although not part of the original report, it is interesting to note that trauma to the injection sites were observed.  Walter Bond recalled the experiment many years later in an email with a colleague-friend.  Bond stated upon visiting Jake in the animal quarters the following day that the injection sites looked “agggh!”

 

Results No Longer Valid
The Phoenix Labs’ radioimmunoassay method of HBsAg detection, albeit novel for 1977, quickly became outdated.  Advances in science ushered in more precise Hepatitis B assays capable of detecting extremely low levels of HBsAg.  These advances made the results of the Special Investigations Team no longer valid.

Imagine using a magnifying glass.  Several years later, a more powerful lens with a greater magnification emerges allowing things previously unseen to be observed.  Very similarly advances in medicine have allowed for low levels of Hepatitis B surface antigen previously unseen to be observed.

In 1984, Feinman and colleagues found DNA hybridization to be a far more accurate tool than radioimmunoassay in detecting low levels of HBsAg.  Precisely 1,000 times better.  Radioimmunoassay detects HBsAg in dilutions as small as 1/ 100,000 milliliters or rather 10-5 mL.  Whereas DNA hybridization detects as small as 1/ 100,000,000 milliliters or rather 10-8 mL within the same samples (Feinman et al., 1984). This is a huge difference!

“DNA hybridization is the most sensitive method for detecting hepatitis B virus (HBV) infection.  In situations with low virus levels it may be the only indicator of the presence of infectious hepatitis B virus,” wrote Feinman in 1984.

The discovery by Feinman and colleagues made HBsAg detectable in microscopic levels previously unheard of in the medical community.  With this method they found the minimum known volume of blood capable of transmitting Hepatitis B virus was 100 million chimpanzee-infectious doses per milliliter (Feinman et al., 1984).  Former Lead Researcher on Vaccine Technology within the CDC, Dr. Bruce Weniger stated, “This converts to 10 picoliters (10-8 mL) of HBV-infected blood transmitting infection, well below the sensitivity to detect blood by human vision, by common urine dipstick, and by non-PCR HBV assays” (Weniger, Jones & Chen).

Therefore, the radioimmunoassay used by the Phoenix Lab, a non-polymerase chain reaction Hepatitis B virus assay, could not detect positive samples within such low levels.  Neither would the Hemastix urine dipstick be able to detect such low levels.  These tests would give false-negative, or rather would falsely deem a positive sample to be negative.  Ultimately, low levels of infectious Hepatitis B surface antigen could have been transmitted within this study and could have gone undetected.

For any critics who would argue that such low levels of blood would not be infectious or carryover to the next vaccinee…think again.  As stated within the last article, subsequent research on jet injection has demonstrated cross-contamination of blood (Hoffman et al., 2001; Hoffman et. al., unpublished), infectious material (Brink et al., 1985), and the Hepatitis B virus (Kelly et al., 2008) in such low levels.  In fact, in several samples which demonstrated carryover there was no observable bleeding at the injection site.  This means that microscopic levels of blood and viruses were transmitted via jet injectors despite the absence of any visible bleeding.

From these experiments the team summarized it’s findings.

Next Article – December of 1977 Summary

 

References:

  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (Feinman et al., 1984) Feinman SV, et al. DNA: DNA hybridization method for the diagnosis of hepatitis B infection. J Virol Methods 1984;8(3):199-206
  • (Hoffman et al., 2001) 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.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (Kelly et al., 2008) 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.
  • (Weniger, Jones & Chen) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Future Vaccination Methods. [Poster Presentation]

 

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