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Did Shots Cause Hepatitis C? Officials Downplay Concerns- They found the genetic fingerprint in batches used for decades to inoculate soldiers against hepatitis A and B

Studies show in 1984 more than half of the commercial intramuscular immune globulin lots, including specific immune globulin. All immune globulin products examined were reactive for anti-HCVproducts, were HCV RNA positive. All immune globulin products examined were reactive for anti-HCV. Concluded the need for a screening test to identify the agent in blood products, and shows that Cohn fractionation of plasma does not always inactivate the agent

Process changes several times but in1999 finally determined –Oncley fractionation does not work: Safety and availability of immunoglobulin replacement therapy in relation to potentially transmissable agents- Cohn–Oncley fractionation is not sufficient to remove lipid-coated viruses, additional antiviral inactivation steps are required.
 

Table of Contents

1843 -1987 History of Syringes
1920-87 Global Disaster Prediction
1942 Seeff- Yellow Fever Vaccine
1950's Korean War Blood and Plasma
1960- Irish Supreme Court in 1992
1970 Intradermal Inoculation with Jetguns
1976-1996 ISG Defined & Products
1977 Seeff- Discovery of Hepatitis C
1978 ISG- 90% Contaminated
1982 Plasma derivatives & hepatitis
1984 Hep C Outbreak
1986 ISG Formula- 3 Generations
1992 - 1996 Contaminated Immunoglobulin Research
1992 Partitioning of hepatitis C virus unsafe
1993 MMWR Contaminated Immunoglobulin Research
1994 HCV RNA in immune globulins
1994 Hepatitis C Immunoglobulin Associated
1994 Hepatitis C ISG product recall
1994 ISG Contaminaton
1994-1998 Hepatitis C Veterans Federal Response
1995 FDA/ORA Blood Compliance Guidance
1997 Did Shots Cause Hepatitis C?
1997 DoD Jetgun Report
1997 immunoglobulins responsible for hepatitis transmission
1998 Hepatitis in Human Albumin
1999 Hepatitis C Survives
1999 Immunoglobulin Transmits Hepatitis C. True or False?
1999 Military military training bases during the late 1960s and 1970s
1999 Prevalence of Hepatitis C
2003 Tainted Blood Class Action
2005 Immunization to Protect the U.S. Armed Forces
2008 The hazards of blood transfusion
Safety and availability of immunoglobulins

 

 

Table of Contents  
1843 -1987 History of Syringes Syringe reuse a widespread problem: U.S. expert- ...larger problem than once thought, even though the practice is inexcusable...hepatitis outbreaks linked to dirty syringes
1920-87 Global Disaster Prediction DEADLY NEEDLES Fast Track to Global Disaster- For decades, researchers warned...syringes could transmit ... efforts to defuse the crisis were failed, and today...become an insidious global epidemic, destroying millions of lives every year.
1950's Korean War Blood and Plasma The Blood, Plasma, and Related Programs in the Korean War- A plasma program was also developed which later had to be discontinued because of the risk of serum hepatitis associated with plasma infusions
1960- Irish Supreme Court in 1992 In the 3 years after Wellcome produced the toxic batches, dozens of British parents believed their children suffered brain damage or even died as a result of the whooping cough vaccine. But their views were dismissed by drug companies and health officials.
1970 Jetgun Warning & Vaccines Though smallpox vaccination by jet injection is accepted in the U.S.A." it is rarely carried out in Britain, partly because of problems associated with the dilution of vaccine LYMPH to volumes...used by jet injectors, and partly because LYMPH is NOT necessarily bacteriologically sterile...regarded as unsuitable for intradermal inoculation." Lymph is the same thing as blood plasma....and plasma contains a protein called ALBUMIN. So if plasma is not sterile then neither is albumiin.
1977 SInce late 1974 and early 1975, several cases of viral hepatitis were reported in Italy among subjects who had received subcutaneous injections of a drug containing human immunoglobulins
1977 Warning Furthermore, the efficacy of the ISG, manufactured in 1944, against apparent type non-A, non-B hepatitis suggests that this overlooked disease has existed from at least that time.
1978 ISG- 90% had acute HCV 14 batches of anti-D immune globulin contaminated with hepatitis C virus... Within 6 months after anti-D administration, 10% of these women had no evidence of disease and 90% had acute hepatitis C
1982 Plasma derivatives & viral hep low-risk irrespective of the plasma from which they are manufactured because they are heated at 60 degrees C for 10 hours (Albumin, Plasma Protein Fraction) or because they contain protective antibodies (Immune Globulin).
1984 Hep C Outbreak This outbreak emphasises the need for a screening test to identify the agent in blood products, and shows that Cohn fractionation of plasma does not always inactivate the agent
1986 ISG Formula- 3 Generations More than half of the commercial intramuscular immune globulin lots, including specific immune globulin. All immune globulin products examined were reactive for anti-HCVproducts, were HCV RNA positive. All immune globulin products examined were reactive for anti-HCV.
1987 DoD Follow-up Serologic Follow-up of 1942 Epidemic of Post-Vaccination Hepatitis in the U.S. Army- outbreak was linked to specific lots of yellow-fever vaccine stabilized with human serum
1992 Partitioning of hepatitis C virus during Cohn-Oncley fractionation of plasma. Most of the HCV RNA was found in cryoprecipitate and in Cohn fractions I and III, but it was also detected in fraction II
1992-1996 Contamination Contaminated Immunoglobulin Research
1993 Outbreak of Hepatitis C Associated with Intravenous Immunoglobulin Administration — Since mid-May 1994, approved manufacturing process includes a solvent-detergent treatment designed to inactivate contaminating viruses.
1994 Detection HCV RNA in immune globulins More than half of the commercial intramuscular immune globulin lots, including specific immune globulin. All immune globulin products examined were reactive for anti-HCVproducts, were HCV RNA positive. All immune globulin products examined were reactive for anti-HCV.
1994 HCV Transmission Human Immunoglobulins for Intravenous Use and Hepatitis C Viral Transmission
1994 Hepatitis C ISG product recall At the end of February 1994, Baxter Healthcare announced the removal of Gammagard from the global market because of plasma used was positive for hepatitis C. In July 1995, the FDA said that as many as 1,000 cases of hepatitis C could have been linked to use of Gammagard.
1995 FDA Guide to Inspections of Blood Banks-Cohn-Oncley method relies on precipitation of plasma proteins
1997 Did Shots Cause Hepatitis C? Officials Downplay Concerns- They found the genetic fingerprint in batches used for decades to inoculate soldiers against hepatitis A and B
1997 DoD Jetgun Report Vaccines in the Military- Wide review of Vaccine Policies and Procedures ... says, ...jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed."
1998 manufacture of human albumin Chromatographic removal and heat inactivation of hepatitis during the manufacture of human albumin- purpose to examine efficacy... manufacturing process
1999 Immunoglobulin Transmits Hepatitis C. True or False?...The safety of HCV-RNA-positive intramuscular immunoglobulin preparations can be attributed to several factors:Cohn Fraction- Since 1971, hepatitis B surface antigen-positive blood units have not been included in immunoglobulin starting material. Since 1985 and 1992, also anti-human immunodeficiency virus-1- and anti-human immunodeficiency virus-2-positive units, respectively, have been discarded.
1999 Safety and availability of immunoglobulin replacement therapy in relation to potentially transmissable agents- Cohn–Oncley fractionation is not sufficient to remove lipid-coated viruses, additional antiviral inactivation steps are required.
1999 Military Link Hepatitis C Origin Points to Military...Responses to the request by the Department of Defense indicate that soldiers at major U.S. military training bases during the late 1960s and 1970s were used to test vaccines...
2005 DoD List Vaccines Given to All Troops Descriptions: Immunization to Protect the U.S. Armed Forces: Heritage, Current Practice, Prospects from DoD, Office of the Surgeon General, U. S. Army..
2008 The hazards of blood transfusion in historical perspective Current technologies require the addition of either psoralens or riboflavin to blood, followed by exposure to UV light. These methods are being applied to platelets in Europe and will comp
Contaminated Immunoglobulin Research Outbreak of hepatitis C associated with intravenous immunoglobulin administration--United States, October 1993-June 1994. MMWR
ISG Defined & Products Information about ISG- Immune serums (immune globulin) provide passive immunity to infectious disease
 Prevalence of Hepatitis C ...resulted in a policy of immune globulin use for all deployed soldiers. By 1970, rates were one-half to one-third of the earlier rates... Hepatitis B immune globulin is listed as a Red Cross Risk Factor for transmission of Hepatitis C.

 

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