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

 

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