HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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D Key Documents Provided to the Committee
D Key Documents Provided to the Committee
Pages 263-302
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From page 263... ...
5. American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers.
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From page 264... ...
14. American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers.
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From page 265... ...
Concurrent with the work of the panel, CDC will be working closely with NKF and hemophilia treatment centers to establish a carefullyplanned surveillance and reporting system, and will keep NHF posted on new developments. NHF will keep you informed, but once again, CDC is not advising a change in treatment regimen at thi s time.
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From page 266... ...
Invited participants Preluded representatlYes of the COO, fDA, NIH, National Hemophilia foundation, American National Red Cross, various blood banking organizations, National Gay Task Force, New York City Health Department, and the New York In.e.-Hospital Study Group on the Acquired Imoune Oef$clency Syr~rane (AIDS) and Kaposi's Sarcoma (KS)
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From page 267... ...
Hemophilia patients use large a~unts of Factor VIII (4O,000 to over 65,000 factor units pen year) from multiple preparations with subsequent potential exposure to material derived from thousands of donors.
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From page 268... ...
4. There is need to determine if certain blood products, particularly factor VIII, are risk factors for AIOS.
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From page 269... ...
. Much attention has been focused on the incidence of Acquired Immune Deficiency Syndrome (AIDS)
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From page 270... ...
4. the have prepared the following information for distriEtuion in the Alpha Therapeutic Donor Centers: a.
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From page 271... ...
4.1.3.9 "I certify that all donors whose plasma is contained within this shipment have certified they are not from or have not been in Haiti; have never used illicit drugs intravenously; and that male donors have never had sexual contact with a man.U ALPHA THERAPEUTIC CORPORATION 3~': Cal David J Gury (J Vice President, Plasma Supply Marietta Care Vice President, Regulatory Affairs Pre s ident
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From page 272... ...
2) Have you ever used illicit drugs intravenously?
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From page 273... ...
Invited participants included representatives of the National Hemophilia Foundation, American National Red Cross, various blood banking organizations, National Cay Task Force, New York and San Francisco Health Departments, Conference of State and Territorial Epidemiologists and the Pharmacautica1 Manufacturers Association as well as staff members of the CDC, FDA and HIH (Attachment 1)
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From page 274... ...
g., a positive response to questions such as, Stave yolk t ad sexual contact filth another mans, Afire you a past or present intravenous drug users-, "Are you Haitian?
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From page 275... ...
The FDA expects an improved Factor VIII concentrate to be available within 12 months. This product would be heat created sufficiently to ~ naceivate hepatitis B virus and presumably eliminate other transmissible ;~£.ents from the finished product.
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From page 276... ...
They hare differing perceptions of: The l4lcelihoad that AIDS is caused by' a transmissible agent; 2. The risk of AIDS from blood donation (both whole blood and pooled plasma)
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From page 277... ...
The disease has been called Acquired Immune Deficiency Syndrome (~IDS )
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From page 278... ...
This joint statement wan developed by the American Association of Blood Banks, the American Red Cross, and the Council of Con ity Blood Centers, wig assistance from the American Blood Commission, National Gay Task Force, and the National Hemophilia Foundation Resources Association, the Centers for Disease Control and the Food and Drug Administration.
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From page 279... ...
Identiflca~cion, by direct questioning, individuals who belong to groups at high risk of transmitting A=S, specifically male homosexuals; intrr`,renous drug users; and those who have recently resided in Haiti.
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From page 280... ...
factor concentrates by recombinant DNA technology. Recommendations to regional and community blood centers: A
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From page 281... ...
I have no doubt that they will continue to support us and, should we need to be more aggressive in this area, wil 1 help us do it in a way that is social ly responsible. Blood banks that wish to sell plasma for further fractionation already face the need to do something.
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From page 282... ...
Having individuals who are not associated with the blood banks nor a traditional pert of the blood banking community provedmost useful to us. Their comments and suggestions were excellent.
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From page 283... ...
recommends that its member firms who are involved in the collection of plasma for the manufacture of certain products used ~ n the treatment of hemophilia, a coagulation deficiency, take the following actions to eliminate plasma donors who may be in those groups identified as having a high risk to Acquired Immune Deficiency Syndrome (AIDS)
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From page 284... ...
Assessment of issues such as the adequate availability of testing reagents and equipment of any of the several possible tests under consideration, Weir 'economic and logistical impact upon che plasma supply network, the efficacy of the test to exclude high risk individuals, and other potential consequences to plasma products resulting f as the imposition of additional testing requirements is currently under S\.~3y These AaRA recommendations are intended to apply to all plasma donors collected by plasmapheresis for use in the production of antihemophiliac factor concentrate. The Association is forwarding these recommendations to other national and international organizations concerned with donor standards and blood and blood product quality.
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From page 285... ...
; (3) homosexuals ant bisexuals constitute up Ha 25- of Arc donor population; (I)
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From page 286... ...
do Fort 2 Dr. ~tz's 1/26183 AIDS Yam HIV AND THE BLOOD SUPPLY only Hale gays that are tssoc11t~ city AIDS.
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From page 287... ...
I personally believe that direct questicnir.` mill be ccunterproduct1Ye in most ARC regions, given the public nature of the broad donation process. How many men in Buf~zlc, t{ew York are Scorn; to Oreo forward, out of their closet.
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From page 288... ...
direct Questions and lab tests. rurthennare (e)
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From page 289... ...
APPENDlX D an. ~ omit 'Pet S Or.
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From page 290... ...
frog Blood Donors TO: ~1 Establishments ~lleccing Human Blood for Transfus10n We Acquired Immune Deficiency (AIDS) ,Syndrome As caused serious concern _~ meters of the blood b~i~ =_nity Cause of the 1~11cat1~ for transfus10n recipients if this disease is proven co be transmissible by blood or blood products.
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From page 291... ...
Approved procedures developed by one of the major organizat10ns such as the American Red Cross, the American ^ssociacton of Blood Banks, the Council of Comounity Blood Centers and the American Blood Resources Association cay be referenced in the licensed establishments' SOP without individual suboiss10n co che Office of Biologic6. AlternativeIy, licensed establishoenta which develop their own procedures should submit them directly to the Office of B1010gics for approval concurrent rich 1mplemeataCtoa~ This memorandum is intended to be an interim measure to protect recipients of blood and blood products until specific laboracory tests are available.
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From page 292... ...
Ins ~4 ~ ~ D[r^kT>lt~T ()
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From page 293... ...
Approved procedures developed bY one of The major orgauizaticns such as Che American Bl006 Resources As60ci8210=, the American Red Cross, the American Association of Blood Banks and the Council of O amenity Blood Centers may be referenced in the licensed escabltshmenc~s SOPS w1thouc individual submission co the Office of Biologics. Alternatively, licoused establishoencs which develop their own procedures should submit them to the Office of Biologics for approval concurrent with 1cplecentation.
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From page 294... ...
Plasma collected frog dodgy q,gp~t~d of being fit increased risk of n~g IS Is -~ Hi: ~ ~ s~t~ ~ 6~S suggescive of AIDS, sexually active ho~osexuaI or bisex~1 men with multiple partners, Haitian entrants to the United States, present or past abusers of intravenous drugs* and sexy partners of persons at increased risk of AIDS)
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From page 295... ...
Abe THE AIDS Task Force considers this to be an inappropriate response and urges hemophiliacs to maintain the use of clotting factor in their treatment of hemorrhagic episodes. In order to reduce the possible transmission of AIDS through blood products the FDA has issued recommendations regarding the screening of potential donors for blood and plasma fractionation collection agencies.
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From page 296... ...
However, we urge that patients and treaters recognize the need for careful evaluation of blood products and note that such a recall action should not cause anxiety or changes In treatment programs. We emphasize that the incidence of AIDS in hemophiliacs is very low (12 patients out of nearly 20,0803 and that the life and health of hemophiliacs depends upon blood products.
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From page 297... ...
~rch 25, 19O, ~ rc~poD'e to the potebti.1 ri'L @f tr8usfu~ion.~#oci~ted ^=S, ve ple~ge4 cg~pllaDce witb cbe k~co~-eod'tion' on A=S by the O;fice of Iiologics, I~, "oaf jolucly ~l~:ed ~ ~Cio~de progi co ~f6= .11 blood donor' of A=S =~'k groups "nd provided =~' for ~divid~l; ~ bl ~ =~k group' co be "eluded .' blood dono=~. Re co= vith Secre:~= of Ea~lth .od B~n Se~ice' ~rgarat M
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From page 298... ...
fos blood ~d blood producte. Shere is ~ se~.1 cor,cern that donose ~, sefssin fron routi~e blood do~tion' while eYsiti~ seque~ts to psovide disected do~tion~ &~6, ttesety' could ~is~upt the bSood supply ,to the point th~t soutine e~d erven so~c GezlencT r~eed~ for transfusions ~y go usmet.
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From page 299... ...
~ ..s s- .~.~c 0~1e f ·om Sobi'C T 299 l)
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From page 300... ...
. ~" represeucs approx1~y 80 completes aback gnu or operate gore cb.o oue-h~lf of .11 cbe source plasma fac111~1es in the u~1t~ Sag.
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From page 301... ...
(A Dew manuf acturlo8 process may aolve chis problem, but full data arc not yet available.) AFE concentrates have two principal soirees - source plasma and recovered plasma (froze`: placed derived f row whole blood collectloru)
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