HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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4 Product Treatment
4 Product Treatment
Pages 81-100
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From page 81... ...
Although some blood derivative products (e.g., albumin) have been treated with heat to destroy live viruses since the late 1940s, Factor VIII and IX AHF concentrates in the United States were not subjected to procedures of viral inactivation until 1983-1984.
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From page 82... ...
· What was the role of the Food and Drug Administration and the National Institutes of Health in encouraging or supporting research on viral inactivation methods to improve the safety of AHF concentrate? The Committee developed two hypotheses to explain the actions that were taken during the period from 1970 to 1983: · Plasma fractionators and other organizations responsible for the safety of blood products did not begin research on viral inactivation of AHF concentrates until the onset of the AIDS epidemic.
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From page 83... ...
Supporting evidence accrued during World War II as the constant demand for blood and plasma administration during battle led to the recognition that a serious transmissible illness was affecting large numbers of soldiers following transfusion. Studies conducted in the United States and England following World War II identified two viruses, one with a short incubation period that could be transmitted both orally and parenterally, and the other with a long incubation period and transmissible only parenterally.
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From page 84... ...
Transmission of HBV principally results from exposure to blood or blood products, although sexual transmission is also common. During the 1960s, up to 10 percent of persons who received massive transfusions acquired HBV infection and more than 80 percent of individuals with hemophilia were infected through their use of contaminated pooled AHF concentrate.
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From page 85... ...
After 1975, according to Dr. Robert Gerety, chief of the Hepatitis Branch, Division of Blood and Blood Products in the Bureau of Biologics at the FDA at the time, no lots of either Factor VIII or Factor IX submitted to the bureau contained detectable HBsAg; but despite this, the problem of HBV infection following administration of the AHF concentrate would remain serious (Gerety and Barker 19761.
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From page 86... ...
. Second, a German pharmaceutical company, Behringwerke, A.G., initiated studies in 1977 on heat inactivation methods for AHF concentrate (Weidmann and Hoechst 19931.
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From page 87... ...
a pasteurization procedure that requires the heating of AHF concentrate at 60°C for 10 hours, using sucrose and glycine as stabilizers, before lyophilization. Behringwerke's "heat sterilized" Factor VIII was licensed in Ge~any in May 1981 (Weidmann and Hoechst 19931.
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From page 88... ...
manufacturers in the early 1980s: (1) In 1979, the Baxter Healthcare company initiated studies on heat inactivation of AHF concentrate using a "dry heat" process.
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From page 89... ...
The group issued a recommendation to urgently determine practical techniques for decreasing or eliminating the infectious risks from AHF concentrate. Meeting participants discussed several viral inactivation methods that were under study and that a meeting of the FDA's Blood Products Advisory Committee (BPAC)
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From page 90... ...
However, the Committee did not find any evidence that the NHLBI actually provided any support for intramural or extramural research between 1982 and 1983 to develop viral inactivation methodologies to limit hepatitis transmission by AHF concentrate. Beginning in 1982, NHLBI did support several studies aimed at evaluating the potential transmission of the etiologic agent of AIDS through blood and blood products.
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From page 91... ...
Upon licensure of the change in processing of the AHF concentrate products, the plasma fractionators immediately began producing a proportion of their production output using the added heat treatment step (Hammes pers.
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From page 92... ...
Progress in improving the safety of AHF concentrate could have potentially been encouraged by a variety of sources including the plasma fractionation industry, the NIH, the FDA, and the National Hemophilia Foundation. In evaluating the adequacy of the response of each of these groups, the Committee reviewed the sources of technical innovation and research funding for viral inactivation technologies for
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From page 93... ...
After reviewing the data on the development of viral inactivation, the Committee concluded that Though viral inactivation methods had begun in the late 1970s to eliminate hepatitis' they were not given a high priority for several reasons. First, most individuals with hemophilia had already been exposed to HBV, which led to the perception that these individuals did not need to be protected through viral inactivation of the AHF concentrate (see Chapter 7)
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From page 94... ...
The FDA did convene a BPAC meeting in December 1982 to review the approval process for viral inactivation methods, with a particular focus on the details of the requisite chimpanzee challenge experiments. Several BPAC sessions in 1983 were devoted to viral inactivation and marker viruses (Franantoni 1995~; however, this type of activity primarily served to facilitate, rather than actively encourage, the implementation of viral inactivation technologies.
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From page 95... ...
The Committee found that the plasma fractionators did not seriously consider alternative inactivation processes (e.g., the detergent process) because they placed a low priority on developing inactivation procedures for AHF concentrate and because heat inactivation had been successful tOF over blood products.
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From page 96... ...
Once inactivation methods were developed, the plasma fractionators and the FDA moved expeditiously to license them. Following licensure of the first heattreated AHF concentrate, however, many treating physicians and the National Hemophilia Foundation were slow to encourage their patients to use the new product (see Chapter 64.
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From page 97... ...
It was found that blood supply safety measures adopted internationally included implementation of twostage viral inactivation processes. Other measures included: decreased reliance on blood products imported from other countries; increased centralized oversight, control authorities and processes; regulation of epidemiological surveillance systems; expert advisory panels for research, testing, and quality control; and establishment of a computerized tracking system for monitoring treatment.
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From page 98... ...
"A Sudden Increase in Factor VIII Inhibitor Development in Multitransfused Hemophilia A Patients in the Netherlands." Blood; April 15, 1983.
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From page 99... ...
~ 31" DIf[~ It's O! H~S ~ VI~S MBFIC8= during Plasma Fractionation'" Vox Sang, vol*
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