D
Key Documents Provided to the Committee

1. National Hemophilia Foundation, Hemophilia Patient Alert #1; July 14, 1982.

2. Foege, William H., M.D. Summary Report on Open Meeting of PHS Committee on Opportunistic Infections in Patients with Hemophilia ; August 6, 1982.

3. Gury, David J., Vice President, Plasma Supply, Alpha Therapeutic Corporation. Letter to all source affiliates; December 17, 1982.

4. Foege, William H., M.D. Summary Report on Workgroup to Identify Opportunities for Prevention of Acquired Immune Deficiency Syndrome ; January 4, 1983.

5. American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers. Joint Statement on Acquired Immune Deficiency Syndrome (AIDS) Related to Transfusion; January 13, 1983.

6. National Hemophilia Foundation, Medical and Scientific Advisory Council. Recommendations to Prevent AIDS in Patients With Hemophilia; January 14, 1983.

7. Bove, Joseph, M.D., Chairman, Committee on Transfusion Transmitted Diseases, American Association of Blood Banks. Report to the Board—Committee on Transfusion Transmitted Diseases; January 24, 1983.

8. American Blood Resources Association. ABRA Recommendations on AIDS and Plasma Donor Deferral; January 28, 1983.

9. American Red Cross National Headquarters. Memorandum to Mr. deBeaufort from Dr. Cumming; February 5, 1983.

10. Petricciani, John, M.D., Director, Food and Drug Administration, Office of Biologics. Letter to all establishments collecting human blood for transfusion; March 24, 1983.



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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking D Key Documents Provided to the Committee 1. National Hemophilia Foundation, Hemophilia Patient Alert #1; July 14, 1982. 2. Foege, William H., M.D. Summary Report on Open Meeting of PHS Committee on Opportunistic Infections in Patients with Hemophilia ; August 6, 1982. 3. Gury, David J., Vice President, Plasma Supply, Alpha Therapeutic Corporation. Letter to all source affiliates; December 17, 1982. 4. Foege, William H., M.D. Summary Report on Workgroup to Identify Opportunities for Prevention of Acquired Immune Deficiency Syndrome ; January 4, 1983. 5. American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers. Joint Statement on Acquired Immune Deficiency Syndrome (AIDS) Related to Transfusion; January 13, 1983. 6. National Hemophilia Foundation, Medical and Scientific Advisory Council. Recommendations to Prevent AIDS in Patients With Hemophilia; January 14, 1983. 7. Bove, Joseph, M.D., Chairman, Committee on Transfusion Transmitted Diseases, American Association of Blood Banks. Report to the Board—Committee on Transfusion Transmitted Diseases; January 24, 1983. 8. American Blood Resources Association. ABRA Recommendations on AIDS and Plasma Donor Deferral; January 28, 1983. 9. American Red Cross National Headquarters. Memorandum to Mr. deBeaufort from Dr. Cumming; February 5, 1983. 10. Petricciani, John, M.D., Director, Food and Drug Administration, Office of Biologics. Letter to all establishments collecting human blood for transfusion; March 24, 1983.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 11. Petricciani, John, M.D., Director, Food and Drug Administration, Office of Biologics. Letter to all establishments collecting source plasma; March 24, 1983. 12. Petricciani, John, M.D., Director, Food and Drug Administration, Office of Biologics. Letter to All licensed manufacturers of plasma derivatives; March 24, 1983. 13. National Hemophilia Foundation. Medical Bulletin #7: NHF Urges Clotting Factor Use Be Maintained; May 11, 1983. 14. American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers. Joint Statement on Directed Donations and AIDS; June 22, 1983. 15. Donohue, Dennis, M.D., Director, Food and Drug Administration, Division of Blood and Blood Products. Memorandum to John Petricciani, M.D., Director, Food and Drug Administration, Office of Biologics; July 21, 1983. 16. Reilly, Robert, Executive Director, American Blood Resources Association. Letter to John C. Petricciani, Director, Food and Drug Administration, Office of Biologics; July 27, 1983.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking HEMOPHILIA NEWSNOTES MEMOPHILIA PATIENT ALERT #1 The Centers for Disease Control (CDC) issued a report that three hemophiliacs had developed rare and unusual infections associated with a condition in which there is a decrease in the body's ability to combat disease. These three cases represent an unusually high rate of this disorder and may have developed as a result of an unknown potentially immuno-suppressive agent. One hypothesis that is being investigated by CDC is that the agent may be a virus transmitted similar to the hepatitis virus by blood or blood products. It is important to note that at this time the risk of contracting this immuno-suppressive agent is minimal and CDC is not recommending any change in blood product use. A "blue ribbon" panel of experts is being established within the United States Department of Health and Human Services for the purpose of evaluating the problem. NHF Medical Co-Director, Dr. Louis Aledort, will serve on this panel. Concurrent with the work of the panel, CDC will be working closely with NHF and hemophilia treatment centers to establish a carefully planned 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 this time. IMPORTANT REMEMBER, CDC IS NOT ADVISING A CHANGE IN TREATMENT REGIMEN AT THIS TIME, IF THERE ARE ANY QUESTIONS, CONTACT YOUR PHYSICIAN OR HEMOPHILIA TREATMENT CENTER. July 14, 1982 NATIONAL HEMOPHILIA FOUNDATION 19 WEST 34th STREET·SUITE 1204·NEW YORK, NEW YORK 10001 (212) 563-02

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Summary Report on Open Meeting of PHS Committee on Opportunistic Infections in Patients with Hemophilia The Meeting On July 27, 1982, from 8:30 a.m. to 4:30 p.m. a meeting was held to consider the significance of the occurrence of opportunistic infections (OI) with Pneumocystis carinii pneumonia (PCP) in three patients with hemophilia. Invited participants included representatives of the CDC, 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 Inter-Hospital Study Group on the Acquired Immune Deficiency Syndrome (AIDS) and Kaposi's Sarcoma (KS) (Attachment 1). The morning was spent reviewing the various contributory disciplines related to the problem: the epidemiology of AIDS/KS; immunosuppression associated with AIDS/KS; the course, complications, etc. of hemophilia; description of Factor VIII concentrate and other blood products; and a description of the three hemophilia patients with opportunistic infections. The afternoon was spent discussing the significance of the finding and the appropriate course of action. Aspects of Discussion AIDS (and the sequelae of KS and OI) are occurring in several populations—homosexual men, recent Haitian entrants and I.V. drug abusers. The possibility exists that it is occurring in patients with hemophilia. If the PCP observed in three patients with hemophilia represents the same process as seen in other groups with AIDS, then a possible mode of transmission is via blood products, in this case Factor VIII concentrate. This finding would strengthen the existing hypothesis that AIDS is caused by a transmissible agent. Other seemingly unusual disorders among hemophilia patients were mentioned at the meeting, including cases of Burkitt's Lymohoma, unexplained thrombocytopenia, and possibly other opportunistic infections; but these have not been studied sufficiently to establish their relationship to AIDS. There are 11,000 to 15,000 persons with hemophilia in the United States with varying severity of condition. The morbidity and mortality from hemophilia as well as the lifestyle of hemophilia patients has changed considerably over the past 10 years. These patients are treated with either a product derived from fresh frozen plasma (cryoprecipitate) or a protein concentrate prepared from these precipitates called antihemophilic factor or Factor VIII. Such therapy has allowed the development of home treatment regimens which permit patients to live a more normal life, including sharing educational and vocational opportunities and pursuits with the rest of the population. The number of days of hospitalization annually has decreased markedly for hemophilia patients on home treatment programs. Hemorrhage (spontaneous and traumatic) remains the major cause of death in hemophilia patients.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Almost all patients regularly receiving Factor VIII or cryoprecipitate develop hepatitis B and non-A—non-B (NANB) infections. These products have been shown to transmit these infections. Because of the freedom and reduction of suffering permitted hemophilia patients by Factor VIII concentrate, the product's benefits are perceived by patients to vastly outweigh currently known risks. The Factor VIII normally present in fresh plasma is heat labile and inactivated by many types of chemical or physical treatment. For this reason, the techniques developed for the production of Factor VIII concentrate from fresh plasma are known to have little effect on hepatitis viruses. There are five commercial producers of Factor VIII concentrate. Lots of Factor VIII concentrate are prepared from plasma pooled from 1,000 - 5,000 donors. Donors come from many parts of society. Most material is pooled from paid donors in plasmapheresis centers. Hemophilia patients use large amounts of Factor VIII (40,000 to over 65,000 factor units per year) from multiple preparations with subsequent potential exposure to material derived from thousands of donors. The occurrence of PCP in three patients with hemophilia is disturbing, particularly since there is no previous evidence that this infection is common in hemophilia patients. The two patients who had immunologic studies performed demonstrated a T-cell abnormality similar to that among other patients in other high-risk groups with AIDS/KS. There is no known intrinsic immune disorder in hemophilia patients that would permit or promote such opportunistic infections. Conclusions and Recommendations There was general agreement among all participants on the following: Conclusions The pathologic process should be termed Acquired Immune Deficiency Syndrome (AIDS). Kaposi's Sarcoma and the various opportunistic infections are sequelae of the AIDS state. AIDS has characteristics which suggest an infectious etiology.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking There is an increased risk of AIDS for homosexual men I.V. drug abusers, and among Haitians who have recently enfered the United States. The recent occurrence of PCP in three patients with hemophilia raises the question whether the underlying immunodeficiency seen in these patients has the same etiology as among other groups with PCP. High priority should be given to obtaining information that will answer this question. There is need to determine if certain blood products, particularly Factor VIII, are risk factors for AIDS. To this end, we make the following recommendations: An active surveillance system should be instituted at once to determine if other suspicious cases of AIDS (including OI, KS, or lymphodenopathy) are occurring in hemophilia patients. The CDC, the National Hemophilia Foundation, and the Hemophilia treatment centers volunteered to work together to establish this system and have begun its development. Detailed laboratory studies are needed urgently to develop data relating to the immunologic competence of patients with hemophilia who have no symptoms of opportunistic infection. In addition, it is important to identify promptly and test any patient with hemophilia exhibiting disorders that are considered suspicious (such as thrombocytopenia, Burkitt's Lymphoma, persistent lymphodenopathy, etc.). There is urgent need to determine practical techniques to decrease or eliminate the infectious risks from Factor VIII. Several experimental means of accomplishing this are currently being evaluated. A meeting of the FDA's Advisory Panel on Blood and Blood Products will be held in early September to discuss and evaluate these approaches. There should continue to be broad input into these issues, including representatives from the gay community, hemophilia groups, etc. Concerns were raised over the adequacy of funding to support these new activities, such as active epidemiologic surveillance and intensive laboratory studies. In addition, the existing Federal grants and contracts mechanisms are not responsive to rapid funding of urgent problems. Thus the National Cancer Institute's use of contract funds for AIDS research could not be provided to investigators for at least several months. It would be helpful if the Department could identify resources quickly to assist in these studies.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Alpha THERAPEUTIC CORPORATION 5555 Valley Boulevard, Los Angeles, CA 90032 December 17, 1982 SENT FEDERAL EXPRESS TO ALL SOURCE AFFILIATES (Individual inside addresses and salutations on each letter) Much attention has been focused on the incidence of Acquired Immune Deficiency Syndrome (AIDS) and the possible transmission of this disease through blood products. While there is little known about what AIDS is or how to detect its presence in its early stages, there are three groups of people that have been identified with a higher incidence of the disease, male homosexuals, intravenous drug abusers, people who have been in Haiti. Alpha Therapeutic Corporation is concerned that we take all precautions possible to screen donors to minimize the possibility of transmitting AIDS. Therefore, we have modified our specification for plasma to ask that all donors be screened to exclude donors who may be part of any of the following groups: Persons who have been in Haiti Drug Abusers Male Homosexuals This screening procedure must be in effect by December 27. Plasma collected after December 26, 1982, from donors that have not been screened for these groups should not be sent to Alpha. Please note that this restriction does not apply to donors of special Hepatitis plasma. Enclosed please find: Copy of revision to plasma specification. Copy of screening history form to be included in donor record file. Copy of planned deviation to operating procedures.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking We have prepared the following information for distribution in the Alpha Therapeutic Donor Centers: Copy of memorandum we have prepared for donors. Copy of memorandum for donor center employees. Copy of memorandum to be given to donors that may be deferred as a result of questions. We realize this is not a complete study on AIDS but represents a good portion of the current thinking. You may wish to use this information informing your own donors and employees regarding AIDS. While we recognize the potential for the rejection of long term donors, we strongly believe that the loss of these donors is more than offset by the protection of our patients. We will keep you informed as new data becomes available on this extremely important subject. If you have questions, please contact your regional director or myself. Sincerely, ALPHA THERPEUTIC CORPORATION David J. Gury, Vice President Plasma Supply DJG: mcd attachments ** PLEASE RETURN A COPY OF THIS AS ACKNOWLEDGMENT OF RECEIPT AND IMPLEMENTATION. Signature ___________________ Date ___________________

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Alpha THERAPEUTIC CORPORATION 5555 Valley Boulevard, Los Angeles, CA 90032 December 17, 1982 TO: ALPHA THERAPEUTIC CORPORATION SOURCE PLASMA CENTERS The following changes to Alpha Therapeutic Corporation Commodity Specification 92-3015, Source Plasma (Human), are effective December 27, 1982. 3. REQUIREMENTS (Add) 3.1.6 Donor Screening     3.1.6.1 All donors will be screened to exiled those potential donors who are from or have been in Haiti; have ever used illicit drugs intravenously; and male donors who have had sexual contact with a man. 4. PREPARATION FOR DELIVERY (Add) 4.1.3 Certification     4.1.3.1 Each shipment of Source Plasma will be accompanied by the following certification statement. The document must include name and address of the location; shipping date; and signed by the Center Manager. The Certificate should be attached to ATC Plasma Shipping and Receiving Report form 0192-A-480-RI-10/80.     4.1.3.2 ''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."

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 2DR #0669 Medical Reception will ask all potential donors the following questions in addition to the Medical screening questions currently used: Have you ever been to Haiti? Have you ever used illicit drugs intravenously? Have you ever had sexual contact with a man? (For male donors only). If any of the above questions are answered "yes", the donor must be rejected.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Summary Report on Workgroup to Identify Opportunities for Prevention of Acquired Immune Deficiency Syndrome January 4, 1983 The Meeting On January 4, 1983, from 8:30 a.m. to 4:30 p.m., a meeting was held in Atlanta to consider existing opportunities for prevention of Acquired Immune Deficiency Syndrome (AIDS), both by person-to-person transmission and by blood or blood products. This meeting was a follow-up to a meeting held July 27, 1982 in Washington, D.C. which considered the significance of the occurrence of AIDS in three patients with hemophilia. Invited participants included representatives of the National Hemophilia Foundation, American National Red Cross, various blood banking organizations, National Gay Task Force, New York and San Francisco Health Departments, Conference of State and Territorial Epidemiologists and the Pharmaceutical Manufacturers Association as well as staff members of the CDC, FDA and NIH (Attachment 1). The morning was devoted to reviewing recent information pertinent to AIDS, risk groups and the blood and plasma donation process: the epidemiology of AIDS, AIDS among persons with hemophilia and those receiving transfusions, potential laboratory screening tests, current recommendations and regulations for screening of blood and plasma donors, the demographics of blood donation and the separation and processing of blood and blood derivatives, including Factor VIII. Discussion was then held on various alternative opportunities for prevention. Aspects of Discussion AIDS continues to be a major public health problem. In addition to the previously described high risk groups (homosexual men, intravenous drug users, recently arrived Haitians, etc.), persons with hemophilia are also at increased risk of developing AIDS presumably by introduction of a transmissible agent in Factor VIII concentrate. Five cases of AIDS have been reported in persons with hemophilia since the three described in July and two to three more are considered to be possible cases. One case of AIDS has occurred in an infant who received a platelet transfusion from a man who subsequently was diagnosed as an AIDS patient. Several other AIDS cases under investigation (five) have no risk factors but have received blood products within the past two years. Some participants were reluctant to accept the hypothesis that AIDS has been transmitted by whole blood in the absence of additional evidence. Guidelines for prevention of AIDS cases by person-to-person-transmission were generally accepted by the workgroup (proposed guidelines are in Attachment 2).

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 March 24, 1983 FROM: Director, Office of Biologics, National Center for Drugs and Biologics SUBJECT: Recommendations to Decrease the Risk of Transmitting Acquired Immune Deficiency Syndrome (AIDS) from Plasma Donors TO: All establishments Collecting Source Plasma (Human) The Acquired Immune Deficiency Syndroos (AIDS) has caused serious concein because of the implications for recipients of plasma derivatives if this disease is proven to be transmissible by blood or blood products, The major organizations involved in plasma collection have reached a consensus us to appropriate steps which should be taken to decrease the potential of blood or plasma donation by individuals who might be at increased risk of transmitting AIDS. Consistent with the recommendations of the American blood Resources Association, the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, and the Public Health Service Interagency Committee, (copy attached), the Office of Biologies is advising that the following steps should be taken by all establishments collecting Source Plasma (Ruman): Educational programs should be instituted to inform persons at increased risk of AIDS that until the AIDS problem is resolved or definitive tests become available, they should refrain from routine plasma donation because of the potential risk to recipients of certain plasma derivatives. As presently defined, persons at increased risk include those with symptoms and signs suggestive of AIDS, sexually active homosexual or bisexual men with multiple partners, Haitian entrants to the United States, present or past abusers of intravenous drugs * and sexual partners of individuals at increased risk of AIDS. Each Source Plasma donor should receive information about AIDS including the need for individuals at increased risk to voluntarily exclude themselves from routine plasma programs. If plasma is collected from a donor belonging to any of the groups at increased risk, a label should be affixed to each unit to restrict its use in accordance with 21 CFR 606.120(b)(6). The recommended label statements are "CAUTION: For Use in Manufacturing Albumin, PPF, or Clobulin Only" or "CAUTION: For Use in Manufacturing Noninjectable Products Only". HD-Ag positive plasma is already subject to special labeling and shipping restrictions and these programs are not affected by this memorandum. *   Such intravenous drug abusers are already excluded by existing regulations.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Re-education of personnel responsible for donor screening should be conducted with special attention to identifying the early signs and symptoms of AIDS in donors. The donor medical history should include specific questions designed to detect possible AIDS symptoms or exposure to patients with AIDS. Standard Operating Procedures (SOP) should be revised to include questions which elicit a history of night sweats, unexplained fevers, unexpected weight loss, or signs of lymphadenopathy or Kaposi's sarcoma. Donors should be examined for lymphadenopathy. The initial and annual physical should provide an opportunity for an examination by the physician for generalized lymphadenopathy, while a more limited examination should be performed by an adequately trained individual on each donor on the day of plasma collection and a record made of the results of the examination. An accurate record of each source plasma donor's weight prior to each donation should be made to permit ready identification of any unexplained weight loss. Any significant, unexplained decrease in weight should be considered cause for referral of the donor to a physician for complete evaluation prior to any further plasma collection. Any plasma in storage, which was previously collected from such a donor, should be quarantined until the physician's evaluation is completed. The SOP should inform the staff that any products collected from a donor known or suspected to have AIDS should be considered potentially highly infectious and must be immediately quarantined and disposed of expeditiously and appropriately unless designated for investigative use related to AIDS. If not destroyed, such products must be labeled, stored and shipped in accordance with the standard procedures for handling infectious materials. Appropriate disposal procedures include autoclaving or controlled incineration; overwraps are required to protect staff in case of breakage. Approved procedures developed by one of the major organizations such as the American Blood Resources Association, the American Red Cross, the American Association of Blood Banks and the Council of Community Blood Centers may be referenced in the licensed establishment's SOPs without individual submission to the Office of Biologics. Alternatively, licensed establishments which develop their own procedures should submit them to the Office of Biologics for approval concurrent with implementation. Revised labeling for plasma collected from high risk donor groups and intended for further manufacture of plasma derivatives should be submitted to the Office of Biologics (HFN-825). This memorandum is intended to be an interim measure to protect recipients of blood and blood products until specific laboratory tests are available. John C. Petricciani, M.D. Attachment

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 March 24, 1983 FROM: Director, Office of Biologics, National Center for Drugs and Biologics SUBJECT: Source Material Used to Manufacture Certain Plasma Derivatives TO: All Licensed Manufacturers of Plasma Derivatives Extensive discussions among licensed manufacturers, the Office of Biologics and concerned groups such as the National Hemophilia Foundation, have led to a consensus concerning an appropriate approach to decreasing the potential risk of transmitting Acquired Immune Deficiency Syndrome (AIDS) by certain plasma derivatives. Plasma collected from donors suspected of being at increased risk of transmitting AIDS (as presently defined: persons with symptoms and signs suggestive of AIDS, sexually active homosexual or bisexual men with multiple partners, Haitian entrants to the United States, present or past abusers of intravenous drugs* and sexual partners of persons at increased risk of AIDS) should not be fractionated into derivatives already known to have a risk of transmitting infectious diseases. Plasma from donors in any of the groups identified above may be collected for use in manufacturing only albumin, plasma protein fraction (PPF), globulin or in vitro diagnostic products. To prevent the possible misuse of such plasma, all licensed establishments collecting Source Plasma (Human) are being advised that in accordance with 21 CFR 606.120(b)(6) each unit must be conspicuously labeled either with the statement "CAUTION: For Use in Manufacturing Albumin, PPF, or Globulin Only," or "CAUTION: For Use in Manufacturing Noninjectable Products Only". HBsAg positive plasma for use in manufacturing vaccine or in vitro diagnostic products is already subject to additional special labeling and shipping precautions. We request that you immediately institute procedures with your plasma suppliers to assure that they have adopted appropriate donor screening practices and procedures. Copies of notices that are being sent to all establishments collecting blood or source plasma concerning measures which should be taken, are enclosed for your information along with the recent Public Health Service Interagency Recommendations. Please advise the Office of Biologics, in writing, of the procedures you have instituted to comply with this notice. The restrictions applied by your establishment on source plasma received for manufacturing high risk plasma derivatives should be effective immediately. John C. Petricciani, M.D. Enclosures RETURN – RECEIPT REQUESTED *   Such intravenous drug abusers are already excluded by existing regulations.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking HEMOPHILIA NEWS NOTES May 11, 1983 MEDICAL BULLETIN #7 CHAPTER ADVISORY #8 NHF URGES CLOTTING FACTOR USE BE MAINTAINED Chapters—Please distribute this information to all chapter members. Physicians—Please distribute this information to all providers who treath patients with hemophilia in your area. NOTE: Any questions concerning the following information should be referred to your treating physician and/or NHF. The NHF has recently recognized, and is concerned about, the fact that public media coverage of AIDS is causing some patients to abandon appropriate use of blood products because they fear contracting AIDS. The NHF 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. The guidelines have been developed from the screening criteria recommended by The NHF's Medical and Scientific Advisory Council in January of 1983. A recent event emphasizes the need for careful screening of donors and the maintenance of careful medical records. You should be aware that Hyland Therapeutics Division of Travenol Laboratories, Inc. has judged it prudent for patient safety to recall a lot of AUTOPLEX. The need for such an action is not surprising, since a blood collection agency or plasma fractionation company may recognize the need to recall a product prepared from plasma of a high risk donoz who later developed symptoms of AIDS during the period of plasma fractionation and distribution.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking AIDS BULLETIN It is rot the role of The NHF to judge the appropriateness of corporate decisions made by individual pharmaceutical companies. 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 20,000) and that the life and health of hemophiliacs depends upon blood products. The NHF recommends that patients maintain the use of concentrates or cryoprecipitate as prescribed by their physicians. If you have any questions regarding this matter, they should be directed to your treating physician and/or The NHF.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking JOINT STATEMENT ON DIRECTED DONATIONS AND AIDS The current epidemic of acquired immune deficiency syndrome (AIDS) and attendant publicity has led to concerns that AIDS may be transmitted by blood transfusion to persons not in one of the recognized high risk groups. Of 1,601 cases of AIDS reported to the CDC, 94 percent have occurred in people belonging to four groups: homosexual or bisexual males with multiple sex-partners; intravenous drug abusers, recent entrants from Haiti, and persons with bemophilia. Only one newborn infant and 14 adult recipients of blood transfusions have been identified as cases of possible transfusion-associated. AIDS. More than 10 million persons were transfused in the United States during the three-year period that these cases were reported and, therefore, it appears at this time that the risk of possible transfusion-associated AIDS is on the order of one case per million patients transfused. On March 25, 1983, in response to the potential risk of transfusion-associated AIDS, we pledged compliance with the Recommendations on AIDS by the Office of Biologics, FDA, and jointly implemented a nationwide program to inform all blood donors of AIDS risk groups and provided means for individuals in high risk groups to be excluded as blood donors. We concur with Secretary of Health and Human Services Margaret M. Heckler's statement of June 14, 1983, that ''…all of us might also be confronted with an unnecessary and unjustified level of fear, if misunderstanding of AIDS is allowed to grow. Such a level of fear could actually impede us in our real tasks.…" One consequence of the understandable, but excessive, concern for transfusion-associated AIDS has been requests by patients and their physicians to have blood donors selected from family members, friends, coworkers, and even newly formed private donor clubs. There is no evidence to support this notion that these "directed donations" are safer than those available through the community blood bank. The concept that family members, friends, coworkers, church members or other selected groups are sure to provide safer blood is unrealistic. These same individuals are and have been the nation's volunteer blood donors who have, in the past, given freely for all patients rather than for a particular individual. There is no reason to think that segregating these individuals into selected donor panels will provide safety over and above the level provided by current arrangements. In addition, a system

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking of directed donation may create intense pressures on family and friends who may therefore be untruthful about their ability to meet donor requirements. It is possible that the administrative and operational complexity that will be part of any widespread application of directed donations may lead to a significant increase in clerical errors and, in this way, reduce the safety of transfusion. Finally, there is the risk that widespread attempts to direct donations, while not increasing the safety of transfusions, will seriously disrupt the nation's blood donor system. Voluntary donation is essential for meeting our nation's needs for blood and blood products. There is a real concern that donors may refrain from routine blood donations while awaiting requests to provide directed donations and, thereby, could disrupt the blood supply to the point that routine and even some emergency needs for transfusions may go unmet. Given these considerations, we strongly recommend that "directed donation" programs not be conducted. We reaffirm our commitment to a safe blood supply for all recipients, to maintaining the highest standards possible for selecting volunteer donors, and to strict compliance with pertinent recommendations by the United States Public Health Service and other federal regulatory bodies. American Red Cross American Association of Blood Banks Council of Community Blood Centers June 22, 1983

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking DEPARTMENT OF HEALTH & HUMAN SERVICES Memorandum Date July 21, 1983 From Dennis M. Donohue, M.D. Director, D35P Subject Results of the Blood Product Advisory Committee Meeting Related to the Safety of Plasma Derivatives To John C. Petriceiani, M.D. Director, OOB, HFN-800 My interpretation of the Advisory Committee review of the Safety of Factor VIII in relation to Acquired Immunodeficiency Syndrome (AIDS) is as follows: The risk of transmitting AIDS to an individual hemophiliac from a specific lot of Factor VIII is very, very small if it exists. Therefore, disposition of Factor VIII from a pool which contains plasma collected from a donor who may have the acquired immunodeficiency syndrome should be considered as a discrete incident. A conclusion as to the distribution or destruction of the final product should consider such variables as: the degree of specificity of the diagnosis, the time of onset of symptoms in relation to the time of donation, the potential effect upon immediate supply of factor VIII and the long-term production of this essential plasma derivative. It is emphasized that all aspects of AIDS including the cause, method of transmission, predisposing factors and definition of the syndrome itself, are incompletely understood inspite of the extensive and intensive research activity focused upon these issues and the benefit from life-threatening or disabling hemorrhage far exceeds the risk of acquiring AIDS. Dennts M. Donohue, M.D.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking AMERICAN BLOOD RESOURCES ASSOCIATION P.O. Box 3346 Annapolis, Maryland 21403 (301) 263-8296 July 27, 1983 Reference No. A1901 John C. Petricciani, M.D. Department of Health and He Public Health Service Food and Drug Administration 8800 Rockville Pike Bethesda, MD 20205 Dear Doctor Petricciani: The American Blood Resources Association (ABRA) is the trade association for the collectors of source plasma (human). ABRA represents approximately 80 companies which own or operate more than one-half of all the source plasma facilities in the United States. ABRA has worked very closely with members of your staff, members of the Centers for Disease Control staff, and others in attempting to develop a responsible policy aimed at reducing the risk of transmitting acquired immune deficiency syndrome (AIDS) through blood and blood products. We recognize that the etiology of AIDS is far from clear, that blood and blood products are merely suspect as a source of transmission of AIDS, and that even if blood and blood products were directly linked to AIDS, the mechanism for the causative factor is now unknown. On the whole, we believe that the recommendations promulgated by you on March 24, 1983 to deal with donor screening for AIDS are sound and, in general, workable. In our opinion, however, the March 24, 1983 recommendations contain one serious flaw. The problem arises out of the differences between the requirements applicable to establishments collecting human blood for transfusion and those applicable to source plasma facilities. We note that the last sentence of paragraph one of each of the memoranda is different. It seems to impose a higher standard of donor education on source plasma collectors that upon establishments collecting human blood for transfusion. We do not understand the basis for this difference. A more significant difference is in the omission of paragraphs four and five of the source plasma recommendations from the whole blood collectors. These two paragraphs impose specific medical requirements aimed at ascertaining the health status of particular donors. As explained below, if the recommendations are based on the theory that AIDS is transmissible by blood and blood products, they should be equally applicable to whole blood facilities. It is troublesome to the source plasma collectors that whole blood facilities are not required to perform the same screening. Indeed, the argument can be made that since plasma donors are more closely monitored over time than whole blood donors, whole blood donors should be more carefully screened, rather than the other way around.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Because of the number of apparent AIDS cases among hemophiliacs, AHF concentrate is suspected to be a source of transmission of AIDS. This is consistent with an assumption that a still unknown and unidentified virus causes AIDS. As you know, the fractionation process for AHF cannot assure that any viral matter will be inactivated, as the proteins which induce or support clotting are heat labile. (A new manufacturing process may solve this problem, but full data are not yet available.) AFH concentrates have two principal sources—source plasma and recovered plasma (frozen plasma derived from whole blood collections). Some recovered plasma is derived from hospitals which transfuse red cells or platelets and retain the plasma for sale to a fractionator. Other recovered plasma is custom fractionated for the Red Cross. (Recovered plasma constitutes more than 1,000,000 liters of plasma for fractionation or more than 20Z of the total plasma supply.) As the fractionation process uses "pools" of plasma, a batch of AHF concentrate may be fractionated from a pool containing both source and recovered plasma. Red Cross recovered plasma is also pooled for fractionation. Thus, the safety of AHF concentrate will depend on the quality of both source and recovered plasma. Since it is known that persons who may be at-risk AIDS may donate to plasma and whole blood facilities alike, it is difficult to say with any certainty that recovered plasma is of different or better quality than source plasma. Moreover, a whole blood collection facility cannot and does not know at the time it collects a unit of whole blood whether the plasma therefrom will be put into the fractionation pipeline. There may be justification for regarding the risk of AIDS transmission from whole blood as less than the risk from AHF concentrate because of the difficulty of documenting transfusion-related AIDS. The difference may justify requiring different screening standards for whole blood facilities and source plasma facilities but only if the products derived from whole blood facilities are used solely for transfusion. Since this is not in fact the case, we believe that establishments collecting human blood for transfusion and source plasma establishments should be subject to the same rules. Otherwise, it will be difficult for FDA to assure the public that products being furnished to the American people are safe. We would be happy to discuss this matter with you at your convenience. Plasma call me if you have any questions or if you wish to have a meeting with us. Sincerely yours, Robert W. Reilly Executive Director RWR/cei

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