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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking (1995)
Institute of Medicine (IOM)

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247
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking

C
Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Assessment, Clinical Options, and NHF Actions

 Page
247

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Assessment, Clinical Options, and NHF Actions

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Table C.1 Chronological Summary of Critical Events, NHF Communications, Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action July 16, 1982: CDC MMWR reports immunesuppressive disorder identified in three hemophiliac patients July 14, 1982: Patient Alert #1 sent to NHF chapters and treatment centers Speculation that it may be transmitted similarly to hepatitis virus by blood and blood products Risk is minimal No change in treatment Dr. Aledort, NHF medical co-director to serve on PHS task force           Surveillance and reporting system being planned by CDC with NHF cooperation           ''Dear Colleague" letter sent (July 19, 1982) to physicians by Dr. Aledort asking them to report any cases to state health departments and the NHF July 16, 1982: FDA Office of Biologics holds information exchange meeting on the three cases with NHF and CDC representatives July 19, 1982: Chapter Advisory #2 issued Cause of disease unknown No indication blood products are involved No change in treatment (refers to this as a CDC recommendation)       Epidemic known by CDC in some homosexuals and recent Haitian immigrants Risk is minimal         CDC investigating: (1) linkage between hemophiliacs and other populations; (2) whether the disease may be a virus transmitted similarly to hepatitis by blood products      

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking July 27, 1982: PHS meeting on opportunistic infections in hemophiliacs July 30, 1982: NHF issues Medical Bulletin #2 and Chapter Advisory #3 (no mass mailings to chapter members required) The cause of the dysfunction found in three hemophiliacs is unknown, now defined as AIDS No information provided No information provided NHF agrees to work with CDC, FDA, and NIH to establish surveillance system of hemophiliacs with symptoms of opportunistic infections

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action December 10, 1982: CDC MMWR reports four additional cases in hemophiliacs and one suspect case in an infant who had received a blood transfusion December 9, 1982: NHF issues Chapter Advisory #4 Two cases are children with hemophilia Illness may pose a significant risk for hemophiliacs Advisable not to introduce concentrates to patients who have never used them before (e.g., newborns, children under age 4, newly diagnosed cases, and mild hemophiliac cases) NHF sends out December 10 CDC MMWR to chapter members and emphasizes that patients and parents should be aware of potential risks   December 10, 1982: Medical Bulletin #3 issued Not acquired from contact with each other or other high-risk groups Increased concern that AIDS may be transmitted through blood products       December 21, 1982: NHF issues Medical Bulletin #4 and Chapter Advisory #5 All cases exposed to Factor VIII, no common lots found   No change in treatment for those who have received factor concentrates, and one should not withhold the use of clotting factor therapy when needed NHF provides treatment alternatives to chapter members for individuals not previously exposed to concentrate     No conclusive evidence that cryoprecipitate or fresh frozen plasma will reduce the risk of AIDS       January 4, 1983: CDC meeting in Atlanta to review data January 17, 1983: NHF issues Medical Bulletin #5 and Chapter Advisory #6 Growing incidence and increasing concern among hemophiliac patients that AIDS may be transmitted through blood products   Cryoprecipitate should be used for newborns and children under age 4 MASAC meeting on January 14, 1983, issues 12 recommendations to prevent AIDS in hemophiliac patients; the clinical options (at left) were recommendations made to physicians         Benefits of using cryoprecipitate therapy vs. factor concentrate for severe hemophilia A are under review  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking         DDAVP should be used whenever possible with mild or moderate hemophilia A           Reevaluate all elective surgical procedure  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action March 4, 1983: PHS issues recommendations to reduce the risk of AIDS March 9, 1983: NHF issues Medical Bulletin #6 and Chapter Advisory #7 Sexual contact should be avoided with persons known or suspected to have AIDS; multiple sex partners increase the probability of developing AIDS   Physicians should adhere strictly to medical indications for transfusions, and autologous blood transfusions are encouraged NHF urges Congress to provide additional funding to support AIDS research           NHF issues mental health report to orient those who treat hemophiliacs to the potential impact of AIDS and asks for medical observations, such as: the impact of the AIDS threat (e.g., number of calls from patients); behavioral or emotional problems; evidence of withholding or refusing factor replacement for acute bleeds; and the treatment center's response May 1983: Hyland Therapeutics recalls lot—a donor was identified who developed AIDS May 11, 1983: NHF issues Medical Bulletin #7 and Chapter Advisory #8   Risk is low (12 hemophiliacs out of 20,000 developed AIDS) NHF and NHF AIDS Task Force recommends hemophiliacs maintain use of clotting-factor treatment  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking August 25–26, 1983: Hyland Therapeutics and ARC announce recall of lots (two each) from identified donors who were confirmed to have died of AIDS September 7, 1983: NHF issues Chapter Advisory #9 Not scientifically established that AIDS is transmitted through blood products   NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as prescribed by their physicians October 31, 1983: Cutter Laboratories announces withdrawal of 13 lots of Factor VIII and 1 lot of Factor IX, all from a donor who recently died of AIDS November 2, 1983: NHF issues Chapter Advisory #11 Not scientifically established that AIDS is transmitted through blood products Only a fraction of 1% of all hemophiliacs have contracted AIDS Despite the concern that may be raised by the recall of plasma products, the NHF reaffirms its recommendation that patients maintain the use of concentrate or cryorecipitate as prescribed by their physicians       No common lots have been identified, thus suggesting the great majority of hemohiliacs are not susceptible to AIDS  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action December 2, 1983: CDC MMWR update on AIDS in hemophiliac patients; results of treatment center survey show no cases occurred before September 1981; 21 hemophiliacs have been diagnosed with AIDS, additional patients have been reported with AIDS-related symptoms that do not fit the CDC criteria for an AIDS diagnosis December 2, 1983: NHF issues Medical Bulletin #8 with attached CDC MMWR (December 10); Medical Bulletin #9 and Chapter Advisory #12 issued on December 21, 1983 Etiology remains unknown, epidemiological evidence suggests an infectious disease   MASAC revises January 14, 1983, recommendations to prevent AIDS: adds modification of donor screening language; screen donors for symptoms; expedite the development of processing methods to inactivate viruses potentially present in factor concentrates       Possibility of transmission by blood and blood products is supported by increased incidence of AIDS in IV drug users and transfusion recipients           Cryoprecipitate and factor concentrates are associated with transmission of known viral agents (i.e., cytomegalovirus, hepatitis B, and non-A, non-B hepatitis)       January 16, 1984: Alpha Therapeutic recalls three lots contaminated with AIDS from a donor diagnosed with AIDS NHF issues Medical Bulletin #10 and Chapter Advisory #13     NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as prescribed by their physicians MASAC recommends to blood product manufacturers that any lot of concentrate be recalled if it includes material from an individual who has been identified as having AIDS, or from an individual who, in the best judgment of the manufacturers, has characteristics strongly suggestive of AIDS

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking January 1984: Annals of Internal Medicine publishes article on sexual transmission of AIDS January 30 and February 3, 1984: NHF issues Medical Advisory #11 and Chapter Advisory #14 First case of sexually transmitted AIDS from hemophiliac to spouse: a 70-year-old hemophiliac died of AIDS in May 1983; his wife had developed symptoms in January 1982 In the medical and scientific communities there are different points of view about whether sexual partners of hemophiliacs are at increased risk for AIDS; but all agree that if sexual partners are at increased risk for AIDS, the risk is "truly remote" Individual patients and their treaters need to consider whether or not they wish to use prophylactic methods if diagnosed with AIDS or strongly suspected of having AIDS; discuss with physician or treatment center team matters concerning sexual activity NHF recommends open discussion between sexual partners and advice from physicians

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action April 2, 1984: core testing initiated April 16, 1984: NHF issues Chapter Advisory #15 January–March 1984:9 new cases of AIDS among hemophiliacs, total now is 33; fluctuations, such as an increase in the number of AIDS cases, are due to the small number base of hemophiliacs; antibody to hepatitis B core protein is found in many of the high-risk groups   DDAVP approved by FDA   April 1984: Lancet publishes Montagnier's isolation of LAV; Science publishes Gallo's isolation of HTLV-III (September 1985) May 9, 1984: NHF issues Chapter Advisory #16 HTLV-III may cause AIDS; both a test and a vaccine are several years away; genetic production of Factor VIII will reportedly also be available in several years       July 13, 1984: CDC MMWR reported 72% of severe asymptomatic hemophiliac had antibody to LAV antigens using the Western blot test July 31, 1984: NHF issues Chapter Advisory #17 and Medical Bulletin #12 HTLV-III/LAV implicated as the causative agent for AIDS; too early for scientific information about the relationship between testing positive and having AIDS Testing positive for HTLV-III/LAV does not suggest a diagnosis of AIDS No information from NHF; CDC MMWR states that prevention measures should stress that transmission has been only from sexual contact, sharing of contaminated needles, and, less often, from transfusion of blood or blood products  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking August 31, 1984: Alpha Therapeutic recalls four lots of Factor VIII and four lots of Factor IX from an identified donor who was confirmed to have AIDS September 6, 1984: NHF issues Medical Bulletin #13 and Chapter Advisory #18     NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as recommended by their physicians MASAC reaffirms October 23, 1983, policy on recall

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Even NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action October 5, 1984: ARC recalls AHF found to have been from a single donor who developed AIDS October 13, 1984: NHF issues Medical Bulletin #15 and Chapter Advisory #20 containing MASAC recommendations concerning AIDS and the treatment of hemophilia Heat-treated products appear to have no negative impact in terms of inhibitor development from heat treatment   On October 13, 1984, MASAC revises its recommendations: treaters using coagulation factor concentrates should strongly consider changing to heat-treated products       Insufficient data to know with certainty whether heat-treated products should be universally adopted; preliminary evidence suggests that HTLV-III/LAV is heat labile   Reevaluate all elective surgical procedures           Use DDAVP for mild or moderate hemophiliacs           Cryoprecipitate should be used for newborns, children under age 4, and newly diagnosed patients; continue treating bleeding episodes with clotting factor as prescribed by their physicians           Provide patient education and psychosocial support   October 26, 1984: CDC MMWR reports information on the viral inactivation success of heat treatment November 5, 1984: NHF issues Medical Bulletin #16 and Chapter Advisory #21 MMWR provides scientific evidence on the efficacy of heat treatment   NHF reiterates MASAC recommendation that treaters should strongly consider changing to heat-treated products  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking November 4, 1984: the media reports that 70%–90% of hemophiliacs are infected with AIDS November 5, 1983: NHF issues Medical Bulletin #17 and Chapter Advisory #22 in response to misleading information 58 Cases of AIDS in hemophiliacs; 32 have died The presence of antibodies for HTLV-III/LAV does not suggest a diagnosis of AIDS   FDA licenses three manufacturers for heat-treated Factor IX (1984) December 11, 1984: NHF issues ''sensitive" Medical Bulletin (#19) that includes a list of AIDS cases among hemophiliacs; 58 cases are listed. Not known whether heat changes effectiveness for patients with inhibitors   Treaters should strongly consider changing to heat-treated products; studies are under way to determine efficacy for hepatitis   December 12, 1984: NHF issues Medical Bulletin #18 and Chapter Advisory #23      

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Critical Event NHF Communication Knowledge Base Risk Assessment Clinical Option NHF Action October 1984: CDC determines that heat treatment is effective against HIV December 4, 1985: NHF issues Medical Bulletin #32 and Chapter Advisory #37     MASAC recommends (and the NHF Executive Committee approves) that physicians prescribe only heat-treated products for patients who do not have inhibitors           Heat-treated products should be used for newborns, children under age 4, and newly diagnosed hemophiliacs           Hepatitis B vaccine should be administered shortly after birth because of the problem of non-A, non-B hepatitis (not eliminated with heat treatment) risks and benefits should be weighed for each individual           DDAVP should be used for mild or moderate hemophilia A patients; when it does not work, these patients should be treated with cryoprecipitate; for newborns, children under age 4, and newly identified patients with mild or moderate factor IX deficiency, fresh frozen plasma can be used, but in many circumstances, heat-treated product Factor VIII or IX may be the more appropriate therapy  

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking         All elective surgery procedures should be evaluated with respect to their advantages and disadvantages         Patients should continue treating bleeding episodes with clotting factor as prescribed by their physicians NOTE: ARC = American Red Cross; CDC = Centers for Disease Control; DDAVP = desmopressin acetate; FDA = Food and Drug Administration; HTLV-III = human T-cell lymphotropic virus, type III; IV = intravenous; LAV = lymphadenopathy-associated virus; MASAC = Medical and Scientific Advisory Council; MMWR = Morbidity and Mortality Weekly Reporter; NHF = National Hemophilia Foundation; NIH = National Institutes of Health; and PHS = Public Health Service.

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Representative terms from entire chapter:

chapter advisory