| 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
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| 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.
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| 1942 Seeff- Yellow Fever Vaccine | 1987 DoD Serologic Follow-up of 1942 Hepatitis Epidemic of Post-Vaccination Hepatitis in the U.S. Army- outbreak was linked to specific lots of yellow-fever vaccine...
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| 1950's Korean War Blood and Plasma | An Army contract with Cutter Laboratories to reprocess 40,000 packages of outdated dried plasma had gone unexpectedly well...A considerable amount of albumin and other fractions could probably be recovered from the plasma unsuitable for reprocessing...
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| 1960- Irish Supreme Court in 1992 | allowed thousands...inoculated in the 1960s and 1970s with toxic...vaccines it knew had not passed crucial safety tests
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| 1970 Intradermal Inoculation with Jetguns | ...lymph is not necessarily bacteriologically sterile and has, therefore, been regarded as unsuitable for intradermal inoculation with jetguns
Page 64 - October 10, 1970 British Medical Journal
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| 1976-1996 ISG Defined & Products | Information about ISG- Immune serums (immune globulin)...safety of immune globulins with respect to HCV transmission is not due solely to the partitioning of HCV away from the immunoglobulin fraction.
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| 1977 Seeff- Discovery of Hepatitis C | 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.
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| 1978 ISG- 90% Contaminated | 14 batches anti-D immune globulin contaminated with hepatitis C virus... 90% had acute hepatitis C
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| 1982 Plasma derivatives & hepatitis | ...low-risk irrespective of the plasma from which they are manufactured because... heated at 60 degrees C for 10 hours (Albumin, Plasma Protein Fraction) or because they contain protective antibodies (Immune Globulin).
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| 1984 Hep C Outbreak | Pooled Plasma- 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
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| 1986 ISG Formula- 3 Generations | Three generations of immunoglobulin G preparations for clinical use.
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| 1992 - 1996 Contaminated Immunoglobulin Research | Various Studies that show contamination of Immune Serum Globulin (ISG)
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| 1992 Partitioning of hepatitis C virus unsafe | his work suggests that the safety of immune globulins with respect to HCV transmission is not due solely to the partitioning of HCV away from the immunoglobulin fraction.
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| 1993 MMWR Contaminated Immunoglobulin Research | Outbreak of hepatitis C associated with intravenous immunoglobulin administration--United States, October 1993-June 1994. MMWR plus additional journal articles... |
| 1994 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.
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| 1994 Hepatitis C Immunoglobulin Associated | FDA was notified 14 possible cases from three different countries of acute hepatitis C among persons who had received Gammagard®*, an intravenous immunoglobulin (IGIV) manufactured by Baxter Healthcare Corporation (Glendale, California).
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| 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.
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| 1994 ISG Contaminaton | It is important to recognize that the serologic testing of immunodeficient patients is not
sufficient.
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| 1994-1998 Hepatitis C Veterans Federal Response | Congressional resports and legislation submitted and a large VA population-based screening study in a 6-week period beginning of 1994 ... for the presence of hepatitis B and hepatitis C markers. 3% were infected with hepatitis B, 21% had hepatitis C.1995 and 1997 the annual number rose from 20,203 to 21,424 to 24,850. 1998 an additional 29,799 unique cases... 64% were Vietnam Era veterans.
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| 1995 FDA/ORA Blood Compliance Guidance | FDA Guide to Inspections of Blood Banks-Cohn-Oncley method relies on precipitation of plasma proteins
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| 1997 Did Shots Cause Hepatitis C? | Intramuscular immunoglobulin preparations are prepared according to the Cohn fractionation process,...n is not sufficient to remove viruses, additional antiviral inactivation steps are required...
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| 1997 DoD Jetgun Report | |
| 1997 immunoglobulins responsible for hepatitis transmission | Subcutaneous injections...average length of incubation period was 111-143 days, and an inverse relation was observed between the number of doses administered and the length of the incubation period. The possibility that immunoglobulins can be responsible for the transmission of viral hepatitis raises a number of theoretical and practical problems concerning control and use of these blood products.
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| 1998 Hepatitis in Human Albumin | Chromatographic removal and heat inactivation of hepatitis during the manufacture of human albumin- purpose to examine efficacy...Cohn fractionation manufacturing process failed...
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| 1999 Hepatitis C Survives | Hepatitis C Survive Treatment with Commercial Sterilants and Disinfectants
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| 1999 Immunoglobulin Transmits Hepatitis C. True or False? | The safety of HCV-RNA-positive intramuscular immunoglobulin preparations can be attributed to ...Cohn Fraction- Since 1971, hepatitis B surface antigen-positive blood units have not been included in immunoglobulin starting material.
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| 1999 Military military training bases during the late 1960s and 1970s | 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...
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| 1999 Prevalence of Hepatitis C | Prevalence of Hepatitis C Among Military Retirees and Veterans. In 1999 it was determined by scientists, the process to make immune globulin was inefficient at preventing the transmission of blood borne pathogens especially HCV.
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| 2003 Tainted Blood Class Action | Hepatitis C claims ... most egregious misconduct in pharmaceutical history... Defendants are American corporations which manufactured blood products |
| 2005 Immunization to Protect the U.S. Armed Forces | Jet-injection devices were first developed in the private sector in the 1940s. Military
scientists adapted the early devices to create needle-free multi-use-nozzle jet injectors capable of
600 or more subcutaneous injections per hour from 1949 onward, primarily for basic training
camps. The Army’s Aaron Ismach and Abram Benenson developed a nozzle for intradermal
vaccination, used in civilian mass smallpox immunization campaigns in the 1960s.
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| 2008 The hazards of blood transfusion | Current technologies require the addition of either psoralens or riboflavin to blood, followed by exposure to UV light. concerns about transfusion-related immunomodulation and the safety of blood that ages during prolonged storage need to be resolved.
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| Safety and availability of immunoglobulins | Cohn–Oncley fractionation is not sufficient to remove lipid-coated viruses, additional antiviral inactivation steps are required.
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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