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

Chapter:D Key Documents Provided to the Committee

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Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Summary Report on Open Meeting of PHS Committee on Opportunistic Infections in Patients with Hemophilia

  1. 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.

  2. Aspects of Discussion

    1. 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.

    2. 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.

    3. 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.

    4. 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. 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.

  2. 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.

  3. 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.

  1. Conclusions and Recommendations There was general agreement among all participants on the following:

    1. Conclusions

      1. 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.

      2. AIDS has characteristics which suggest an infectious etiology.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. 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.

  2. There is need to determine if certain blood products, particularly Factor VIII, are risk factors for AIDS.

  1. To this end, we make the following recommendations:

    1. 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.

    2. 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.).

    3. 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.

    4. There should continue to be broad input into these issues, including representatives from the gay community, hemophilia groups, etc.

    5. 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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:

  1. Copy of revision to plasma specification.

  2. Copy of screening history form to be included in donor record file.

  3. Copy of planned deviation to operating procedures.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. We have prepared the following information for distribution in the Alpha Therapeutic Donor Centers:

  1. Copy of memorandum we have prepared for donors.

  2. Copy of memorandum for donor center employees.

  3. 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

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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."

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

2DR #0669

Medical Reception will ask all potential donors the following questions in addition to the Medical screening questions currently used:

  1. Have you ever been to Haiti?

  2. Have you ever used illicit drugs intravenously?

  3. 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Summary Report on Workgroup to Identify Opportunities for Prevention of Acquired Immune Deficiency Syndrome January 4, 1983

  1. 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.

  2. Aspects of Discussion

    1. 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.

    2. 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.

    3. Guidelines for prevention of AIDS cases by person-to-person-transmission were generally accepted by the workgroup (proposed guidelines are in Attachment 2).

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. A consensus was reached that it would be desirable to exclude high risk donors to reduce the risk of AIDS transmission via blood and blood products. However, no consensus was reached as to the best method of doing this. The principal strategies are:

  1. voluntary restriction by potential donors within high risk groups;

  2. exclusion of donors on the basis of history and/or physical examination at the time of donation, e.g., a positive response to questions such as, "Have you had sexual contact with another man?", "Are you a past or present intravenous drug user?", ''Are you Haitian?" etc. On physical exam, patients with lymphadenopathy, etc. could be excluded.

  3. Use of a "surrogate" laboratory test; a test which when positive is associated with high risk groups for AIDS.

  4. A combination of these strategies.

    All these strategies will be difficult to evaluate for effectiveness.

  1. Voluntary restriction has the advantage of enabling high risk groups to play a major and responsible role in protecting others in society. It is independent of the blood supply system. It is inexpensive, and is relatively easy to initiate. The disadvantages are that it has the limitations of not being able to influence less responsible persons and being unlikely to reach and motivate some proportion of those for whom it is intended.

  2. Questioning donors for their nationality, sexual orientation or personal habits has the advantages of being an easy extension of the screening history already used in blood donation, is inexpensive, can be directed toward high risk groups and causes little disruption in the blood collection and processing routine. It has the disadvantage of being potentially intrusive into personal matters, may be viewed as unethical, might institutionalize a stigma on groups already prone to prejudice and persecution, and may be ineffective in identifying persons in these high risk groups. Concerns about record privacy have been raised. A considerable proportion of practicing homosexual males may not consider themselves high-risk for AIDS and others may be reluctant to disclose their sexual orientation. Similarly, recently emigrated Haitians and drug users may be reluctant to identify themselves. Some commercial plasmapheresis processors are already excluding by history some AIDS high risk groups.

  3. Surrogate laboratory tests have the advantages of being objective and can be done on specimens already being drawn for HBsAg. They respect donor privacy and may be most effective in eliminating potential transmitters of AIDS. They have the disadvantage of adding expense to the blood collection process, both through test cost, administrative overhead, and loss of blood units already collected. Further, they may stigmatize as unsatisfactory many "normal" donors for each potential AIDS transmitter that is rejected.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

For example, if the presence of hepatitis B core antibody is used as a laboratory surrogate screening test:

  1. In CDC's specimen file, 90 percent of known definite AIDS cases are positive for anti-Hbc and would be excluded as blood donors.

  2. Approximately five percent of the general population of voluntary donors are positive for anti-HBc, though this figure may vary by blood center. These results would be determined after collection, and the collected units would have to be destroyed, unless they could be safely and practically processed into other blood products.

  3. The costs of the test might add to the cost of processing. The loss of each destroyed unit represents further expense and there might be additional overhead costs. The costs of preventing an unknown number of AIDS cases (and possibly non-A, non-B hepatitis cases) are unknown, but each such case is very costly in direct and indirect costs and the intangible costs of grief and suffering.

  4. Concern was expressed over availability of adequate anti-HBc test materials. However, information suggests that some companies are already planning production of large quantities of anti-HBc and that demand would provoke an adequate supply.

  5. As the epidemiology of AIDS changes, high risk groups may have lower rates of positivity for anti-Hbc.

  6. This additional laboratory test will require new training and procedures for many laboratories.

  1. Alterations in blood processing could also reduce the risk of AIDS transmission. The FDA expects an improved Factor VIII concentrate to be available within 12 months. This product would be heat treated sufficiently to inactivate hepatitis B virus and presumably eliminate other transmissible agents from the finished product. Although preliminary data on such treated Factor VIII materials suggest that there is little loss in activity, detailed information on increased costs, product availability and likelihood of reducing AIDS risk are not yet available.

  1. Conclusions and Recommendations

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. The workgroup participants represented various organizations, governmental agencies and constituent groups concerned with and affected by AIDS and the blood and plasma donation process. They have differing perceptions of:

    1. The likelihood that AIDS is caused by a transmissible agent;

    2. The risk of AIDS from blood donation (both whole blood and pooled plasma); and

    3. The best approach for establishing altered guidelines for blood donation, donor screening or testing and donor restriction.

  1. The workgroup meeting was successful in presenting the most recent data on AIDS and blood/blood products and as a forum for differing views to be expressed. This enabled all participants to gain further insight and appreciation of an extraordinarily complex health problem.

  2. I recommend that each Public Health Service Agency (CDC, FDA, NIH) provide candidate sets of recommendations for the prevention of AIDS in patients with hemophilia and for the other recipients of blood and blood products to Dr. Jeffrey P. Koplan, Assistant Director for Public Health Practice, CDC. The three agencies should then develop a uniform set of recommendations on AIDS for your office.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

January 13, 1983

JOINT STATEMENT ON ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) RELATED TO TRANSFUSION

American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers

Recent reports of abnormal immune function, Kaposi's sarcoma, and opportunistic infections in some gay males, Haitian entrants, and intravenous drug users and in others suggest that a new disease of unknown etiology has appeared in the United States. The disease has been called Acquired Immune Deficiency Syndrome (AIDS). Over 800 cases of AIDS have been reported with a very high mortality rate. While the major foci seem to be New York, San Francisco and Los Angeles, cases have been reported from other areas of the United States.

The predominant mode of transmission seems to be from person to person, probably involving intimate contact. The possibility of blood borne transmission, still unproven, has been raised. This latter impression is reinforced by eight confirmed cases in hemophiliacs treated with antihemophilic factor (AHF) concentrate, by a case in a newborn infant who received 19 units of blood components, one of which was from a donor who later died of AIDS, and by fewer than 10 unconfirmed case reports in other transfusion recipients. No agent has been isolated and there is no test for the disease or for potential carriers. Evidence of transmission by blood transfusion is inconclusive.

The finding of cases in hemophiliacs, especially those who use antihemophilic factor concentrate, coupled with the long incubation period and the continuing increase in reported cases is of sufficient concern to warrant the following suggestions for action on the part of blood banks and transfusion services. We realize that there is no absolute evidence that AIDS is transmitted by blood or blood products, and we understand the difficulty in making recommendations based on insufficient data. There is a need for additional information about this disease. Public health authorities should allocate resources to study the etiology of AIDS, its mode of transmission, and appropriate preventative measures and therapy. Blood centers and transfusion services should continue to assist public health agencies investigating AIDS. Given the possibility that AIDS may be spread by transfusion, we are obligated to respond with measures that seem reasonable at present. The lack of a specific test means that our major effort must revolve around two areas: 1) additional caution in the use of blood and blood products and 2) reasonable attempts to limit blood donation from individuals or groups that may have an unacceptably high risk of AIDS. Our specific suggestions follow:

  1. Blood banks and transfusion services should further extend educational campaigns to physicians to balance the decision to use each blood component against the risks of transfusion, be they well-established (e.g. hepatitis, cytomegalovirus, malaria) or under investigation (e.g. AIDS).

  2. Autologous blood transfusions, as an alternative to allogeneic transfusion, should be considered more frequently, especially in elective surgery.

  3. Blood banks should plan to deal with increased requests for cryoprecipitate. Altered T lymphocyte function, a component of AIDS, has been reported to be less frequent in hemophilia patients who are treated with cryoprecipitate rather than AHF concentrate. Although this does not necessarily imply that cryoprecipitate is free of risks, this finding may lead to an increased demand for ryoprecipitate.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. Donor screening should include specific questions to detect possible AIDS or exposure to patients with AIDS. In particular, all donors should be asked questions designed to elicit a history of night sweats, unexplained fevers, unexpected weight loss, lymphadenopathy or Kaposi's sarcoma. All positive or suggestive answers should be evaluated before anyone donates.

  2. Persons with responsibility for donor recruitment should not target their efforts toward groups that may have a high incidence of AIDS.

  3. A major area of concern is whether attempts to limit voluntary blood donation by individuals from groups with a high prevalence of AIDS are appropriate at present. This question has medical, ethical and legal implications.

    1. The presently available medical and scientific evidence that AIDS can be spread by blood components remains incomplete. Fewer than 10 cases of AIDS with possible linkage to transfusion have been seen despite approximately 10 million transfusions per year. Ongoing epidemiologic studies of all cases of AIDS are being conducted at this time. Should evidence of a clearly implicated donor population become apparent, specific recommendations to the blood banking community will be made promptly.

    2. There is currently considerable pressure on the blood banking community to restrict blood donation by gay males. Direct or indirect questions about a donor's sexual preference are inappropriate. Such an invasion of privacy can be justified only if it demonstrates clear-cut benefit. In fact, there is reason to believe that such questions, no matter how well-intentioned, are ineffective in eliminating those donors who may carry AIDS. Blood banks should work with the leadership of groups which include some individuals at high risk of AIDS.

  1. While there is no specific test for AIDS, there are laboratory and clinical findings that are present in nearly all AIDS patients. The use of these non-specific markers, for example, lymphopenia, immune complexes, and anti-HBc, are being evaluated in those areas of the country where AIDS is prevalent. We do not advise routine implementation of any laboratory screening program for AIDS by blood banks at this time.

These recommendations are made with full realization that the cause of AIDS is unknown and that evidence for its transmission by blood is inconclusive. We believe, however, that we must respond to the possibility that a new and infectious illness has surfaced. Until more information is available, we believe that the measures outlined above are prudent and appropriate.

We will continue to monitor new developments and revise our position promptly should medical or scientific finding indicate that a different course of action is warranted.

This joint statement was developed by the American Association of Blood Banks, the American Red Cross, and the Council of Community Blood Centers, with 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Recommendations of the Medical and Scientific Advisory Council submitted to the NHF Board of Directors

THE NATIONAL HEMOPHILIA FOUNDATION

THE NATIONAL HEMOPHILIA FOUNDATION MEDICAL AND SCIENTIFIC ADVISORY COUNCIL

January 14, 1983

RECOMMENDATIONS TO PREVENT AIDS IN PATIENTS WITH HEMOPHILIA

  1. Recommendations for physicians treating patients with hemophilia.

    1. It is recommended that cryoprecipitate be used to treat patients in the following groups except when there is an overriding medical indication:

      • newborn infants and children under 4;

      • newly identified patients never treated with factor VIII concentrate;

      • patients with clinically mild hemophilia who require infrequent treatment.

        Similar guidelines should be applied to factor IX deficiency patients where fresh frozen plasma can be used instead of concentrate.

    1. The potential advantages and disadvantages of cryoprecipitate versus factor VIII concentrate therapy for severe hemophilia A are not clear at the present time and are controversial. The Medical and Scientific Advisory Council does not offer a specific recommendation at this time, but will continue to review the data.

    2. DDAVP should be used whenever possible in patients with mild or moderate hemophilia A.

    3. All elective surgical procedures should be evaluated with respect to the possible advantages or disadvantages of a delay.

  1. Recommendations to factor VIII concentrate manufacturers:

    1. Serious efforts should be made to exclude donors that might transmit AIDS. These should include:

      1. Identification, by direct questioning, individuals who belong to groups at high risk of transmitting AIDS, specifically male homosexuals; intravenous drug users; and those who have recently resided in Haiti.

      2. Evaluation and implementation (if verified) of surrogate laboratory tasts that would identify individuals at high risk of AIDS transmission.

      3. In addition, the manufacturers should cease using plasma obtained from donor centers that draw from population groups in which there is a significant AIDS incidence. It is clear from the epidemiologic data that the pool of individuals at risk for AIDS transmission is not uniform throughout the country and that a great deal could be achieved by excluding donors from the "hot spots".

    1. Efforts should be continued to expedite the development of processing methods that will inactivate viruses potentially present in factor VIII concentrates.

      over

      19 WEST 34th STREET · SUITE 1204 · NEW YORK. NEW YORK 10001 · (212) 563–0211

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. There should be an evaluation of the possibility that the yield of factor VIII in pheresis donors could be increased using DDAVP or exercise to maximize yield. This would permit a reduction in the size of the donor pool and would compensate for losses in plasma that might occur due to steps noted above.

  2. There should be an evaluation of the feasibility of fractionating and processing plasma so that lyophilized small pool products are available. While this will certainly be more costly, it may be the only way to break out of the present dilemma without going to an all-cryoprecipitate effort.

  3. Concentrate manufacturers should immediately cease purchase of recovered plasma for factor VIII concentrate from blood centers that do not meet the criteria listed in II A above. These criteria should also apply to the production of cryoprecipitate.

  4. Manufacturers should accelerate efforts towards the production of coagulation factor concentrates by recombinant DNA technology.

  1. Recommendations to regional and community blood centers:

    1. Those centers that are in regions in which there is a very low incidence of AIDS should increase capacity for cryoprecipitate production to be used locally and in other regions.

    2. These centers should evaluate the feasibility of preparing small pool lyophilized cryoprecipitate for hemophilia treatment.

    3. The production of cryoprecipitate should also adhere to criteria detailed in IIA, above.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Report to the Board Committee on Transfusion Transmitted Diseases

The major report of your Committee on Transfusion Transmitted Diseases has been issued as our recommendations to the Association. These few additional paragraphs are more my current views and concerns than a formal committee report. Nonetheless, because of my recent experiences I am anxious to share some thoughts with you.

The report that we have submitted to our members is, in my view, appropriate considering the data at hand. Since we met, however, an additional child with AIDS has been admitted to a Texas hospital. At birth the child had received seven transfusions, one of which came from a donor who now seems to have AIDS. This case increases the probability that AIDS may be spread by blood. Furthermore, the CDC continues to investigate the current cases aggressively and may even have a few more. While I believe our report reacts appropriately to the data at hand, I also believe that the most we can do in this situation is buy time. There is little doubt in my mind that additional transfusion related cases and additional cases in patients with hemophilia will surface. Should this happen, we will be obliged to review our current stance and probably to move in the same direction as the commercial fractionators. By that I mean it will be essential for us to take some active steps to screen out donor populations who are at high risk of AIDS. For practical purposes this means gay males.

The matter of arranging an appropriate screening program is delicate and difficult. We have had excellent cooperation from individuals in the gay community and our deliberations have been made easier by their knowledge and ability to help us. I have no doubt that they will continue to support us and, should we need to be more aggressive in this area, will help us do it in a way that is socially responsible.

Blood banks that wish to sell plasma for further fractionation already face the need to do something. Perhaps our Committee should prepare guidelines with suggested wording for them to use. We are reluctant to do this since we do not want anything that we do now to be interpreted by society (or by legal authorities) as agreeing with the concept - as yet unproven - that AIDS can be spread by blood.

All in all this is a knotty problem and one that we will not solve easily.

I want to make a few comments about the process by which our joint document developed. We spent a great deal of time and energy and did the best we could in attempting to reach a consensus. The difficulty was to get AABB, ARC, CCBC and all the other groups to adopt a position which was acceptable to each other. It was impossible to have a small meeting; everybody wanted to attend. When we got the group together we were able to hammer out a statement that pleased the attendees. Unfortunately, the statement had to go through several iterations with our own Board and the Boards of the other involved organizations. In

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

all probability these modifications resulted in a better statement, but the process of getting these changes incorporated and run back and forth through the three organizations was difficult. We have had a good start at working together on this and we hope to keep it up. The mechanism was a little less smooth when it came to releasing the statements and the public relations that went with it.

I hope that we are equipped psychologically to continue to act together. I have been in contact with ARC (Dr. Katz) and CCBC (Dr. Menitove) and believe that the three of us can, together, work out whatever new problems may arise. We plan frequent conference calls to keep each other informed.

I want to comment about the Committee. They worked well together and I was particularly pleased with the input of advisory members. Having individuals who are not associated with the blood banks nor a traditional part of the blood banking community proved most useful to us. Their comments and suggestions were excellent. In a like manner, we were helped by participants from the National Gay Task Force. As we continue to react to the various challenges before us, I am sure that their help will be essential. Finally, let me acknowledge the help from the Central Office and, in particular from Lorry Rose.

No immediate end to the publicity is in sight and we will get continued calls for us to act more aggressively. We need to do whatever is medically correct. In addition, we may have to do a little more, since we are accused of burying our heads in the sand. We are not being helped by the spate of publicity about this illness, but will continue to react responsibility to whatever scientific and medical information we have.

Joseph R. Bove, M.D., Chairman

Committee on Transfusion Transmitted Diseases

American Association of Blood Banks

JRB: tmf

1/24/83

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

ABRA American Blood Resources Association P.O. Box 3346 • Annapolis, MD. 21403

January 28, 1983

ABRA RECOMMENDATIONS ON AIDS AND PLASMA DONOR DEFERRAL

The American Blood Resources Association (ABRA) recommends that its member firms who are involved in the collection of plasma for the manufacture of certain products used in 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).

In the past two years, over 800 cases of AIDS have been reported in the United States. The disease is of unknown etiology, resulting in abnormal immune function, Kaposi's sarcoma and opportunistic infections with a high mortality rate. It appears most frequently in homosexuals, Haitians, and intravenous drug abusers. Several recent cases of AIDS in hemophiliacs and in recipients of various blood products, suggest that AIDS may be of infectious etiology.

The American Blood Resources Association represents the United States commercial plasmapheresis industry who performs 10 million plasmapheresis procedures each year, representing one-half of all donor collections in the United States. ABRA is concerned that steps be taken as soon as possible to screen plasma donors to minimize the possibility of transmitting AIDS. After extensive discussions with various organizations representing the Public Health Services, national blood banking groups and the National Hemophilia Foundation, the leadership of ABRA believes that the most significant action which can be taken, at this time, to reduce the potential risk of AIDS in certain plasma products, is to seek either voluntary donor exclusion or to modify the donor screening procedures to eliminate individuals from the plasma donor population who are in those groups identified as having a high risk to AIDS.

ABRA recommendations focus on three areas: 1) donor education, 2) donor screening, and 3) surrogate laboratory testing.

In the area of education, the Association recommends the preparation of an information document describing AIDS, including statements on how individuals in high risk groups may reduce their risk of exposure, and statements intended to discourage high risk individuals from donating plasma. In addition, the Association recommends that plasmapheresis center management initiate staff education programs on AIDS and its symptomatology.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

For donor screening, the Association recommends that donors be required to read the information about AIDS and acknowledge that they are not members of the high risk groups identified; and that individuals in high risk groups be excluded from donating plasma. Further, on a continuing basis, expand the medical history and examination to include the question, ''Have you had AIDS or close contact with someone with AIDS?" All donors should be asked questions designed to elicit history of night sweats, unexpected weight loss, unexplained fevers, lymphadenopathy, or Kaposi's sarcoma. Anyone found to exhibit any of these symptoms should not be allowed to donate plasma without further medical studies.

For additional laboratory testing, the Association recommends that no large scale testing be initiated at this time. Assessment of issues such as the adequate availability of testing reagents and equipment of any of the several possible tests under consideration, their economic and logistical impact upon the plasma supply network, the efficacy of the test to exclude high risk individuals, and other potential consequences to plasma products resulting from the imposition of additional testing requirements is currently under study.

These ABRA recommendations are intended to apply to all plasma donors collected by plasmapheresis for use in the production of antihemophilic factor concentrate. The Association is forwarding these recommendations to other national and international organizations concerned with donor standards and blood and blood product quality. Each year, the blood banking community recovers plasma from several million voluntary blood donor units which are then used in the production of antihemophilic factor concentrate products used in the treatment of hemophiliacs. Therefore, it is the view of the ABRA leadership that all donors, whether they are participating on plasmapheresis programs or on voluntary blood donor programs, should be screened to eliminate individuals identified in the AIDS high risk groups.

ABRA will consider changing and updating these recommendations as more medical and scientific information becomes available. For more information, call the Association's National Office at (301) 263-8296.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

American Red Cross

To Hr. de Beaufort

Date February 5, 1983

From Dr. Cumming

Subject Dr. Katz's 1/26/83 AIDS Memo

  1. "Is AIDS transmissible by blood?"

  • The available evidence strongly suggests that AIDS is transmissable.

  • The available evidence strongly suggests that AIDS is transmissable via AHF concentrate to hemophiliacs.

  • There is not enough evidence to draw any other scientific conclusions.

  1. "Will elimination of donor groups that are at high risks of contacting AIDS decrease incidents of AIDS? (Note discrepency in approach to Haitian entrants and to gays.)"

    Scientifically, we don't know since the transmission mechanism is unknown at present. In the future, however, it is likely to be shown that such, will be the case. In the interim it will be largely an ethical/political/marketing/legal issue. From the standpoint of product marketing we will be better off making direct and visible attempts at elimination of such groups. Ethically, I don't think sexual preference is the proper business of anyone (or any institution) other than the individuals involved in the sexual act. Legally it would seem that we are open to suit in any event i.e. by the gays if we attempt to exclude them, by patients who might contacts AIDS if we don't make every attempt to exclude gays. Haitians and any other group associated with AIDS. Setting aside the ethical issue, politically and on balance, it would seem we should make every attempt to eliminate as donors all groups associated with AIDS. However, this position leaves us vulverable from a standpoint of scientific leadership and it ignors the question of whether or not attempts to eliminate gays and other groups associated with AIDS will be successful.

  1. "Should ARC pursue (b) above?"

  • The answer to this question lies in staying focused on "the facts."

  • Relevant facts are: (1) the focal group of concern is the gays, we are not likely to incur much resistance with respect to elimination of any other group; (2) as a proportion of the donor population only the gays are significant (greater than 1%); (3) homosexuals and bisexuals constitute up to 25% of the donor population; (4) it is

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

only male gays that are associated with AIDS. thus they probably equal 15% or less of the donor population; (5) the whole blood needs of the total country could be met by 9% of the population between 18 and 65 years old donating once per year (or 6% donor, 1.5 times per year); (6) eliminating all gay males (homosexuals bisexuals) would only increase the population of the population (18 to 65) required to donate once per year from about 9% to [Text incomplete in source] 11% (or 6% donating less than 2 times per year); (7) only a [Text incomplete in source] reportedly "small" subset of days are those associated with AIDS the so called "fast lane" or "bath house'' gays (♀ ≈ 70 different partners and 1100 contacts per year); (8) elimination of only the "fast lane" gays from the donor pool probably would not notice increase the 9% requirement; (9) direct questioning as a means of eliminating gays could be counterproductive; (10) the scientific basis for elimination of gays does not exist at present; (11) [Text incomplete in source] incidence of AIDS is highly concentrated at present

roughly 75% of the cases involve male homosexuals

roughly 95% of the cases involve males

cases have occurred in only 32 of the 50 states

669 of 800 cases (84%) were from just 4 states (New York 51%. California 20%. Florida 7%, and New Jersey 6%)

In each state one or two cities account for the bulk of all cases reported

  • New York City = 97% of cases in New York State

  • San Francisco = 60% of cases in California

  • Los Angeles = 28% of cases in California

  • Miami = 63% of cases in Florida

  • Newark = 40% of cases in New Jersey

(12) historically the incidence of AIDS has been doubling about every six months but this trend is not reflected in figures for November and December 1982.

We are currently pursing elimination of groups at risk of contact AIDS by means which are likely to eliminate all groups with the possible exception of gays (e.g. checks for IV drug use. travel questions, symptom questions, prohibitions on hemophiliacs). And we are working with gays groups on voluntary exclusion. Of those actions which have been suggested, the only things we are not [Text incomplete in source] are:

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

(1) asking direct questions of gays; and (2) laboratory testing of blood samples. As time goes on we are liable to get more and more pressure to utilize these means also. If AIDS continues to double every 6 months, the concentration in gay males continues, and absent evidence to the centrary, this pressure is likely to be overwhelming in 6 to 12 months. Even if the evolving evidence of an epidemic wanes CDC is likely to continue to play up AIDS-- ----it has long been noted that CDC increasingly needs 2 major epidemic to justify its existence. This is especially true in light of Federal funding cuts and fact that AIDS probably played some positive role in CDC's successful battle with OMB to fund a new $15,000.000 viralogy lab. This CDC perspective is also obvious from the general "marketing nature" of the January 4, 1983 Atlanta meeting e.g. abundent press at a "scientific" meeting, presentation without hard copy, hard selling SBA and HBC testing, etc. In short, we can not depend on CDC to provide scientific, objective, unbias leadership on the topic. However because CDC will continue to push for more action from the blood banking community, the public will believe there is a scientific basis and means for eliminating gays.

As I understand it, additional scientific pressure to eliminate gays can be brought to bear from our experience with hepatitus.

In the absence of scientific evidence to the contrary and given the continuing use of direct questioning by the plasma sector, marketing pressure will build for us to use direct questioning.

The bottom line----in the absence of scientific evidence to the contrary, within 6 to 12 months we won't have any choice but to use at least direct questioning and probably laboratory tests to "attempt" to eliminate gay males. I say attempt because the efficacy of both direct questions and laboratory tests are disputable. I personally believe that direct questioning will be counterproductive in most ARC regions, given the public nature of the blood donation process. How many men in Buffalo, New York are going to step forward, out of their closet, in front of their peers and admit they are "queers"? Or even call in later to have their donation discarded?

To the extent the industry (ARC/CCBC/AABB) sticks together against CDC, it will appear to some segments of the public at least that we have a self interest which is in conflict with the public interest, unless we can clearly demonstrate that CDC is wrong. A January 1983 incidence figure which is consistent with November and December 1982 and inconsistent with CDC's hypothesis of doubling every 6 months would be helpful in this regard.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

In the short run our position has all the ear marks of a lossless one. The question would seem to be how do we minimize the short run loss and hopefully gain in the long run?

  1. &

  2. "If ARC pursues (c), how?"

Since (c) refers to (b), this question really means elimination of donor groups at high risk which means gays and methods we are not currently employing viz. direct questions and lab tests. Furthermore (e) can be viewed as providing additional criteria for (d), which is the way I have treated the question below.

In the long term I believe the interests of the ARC and the American public are best served if the ARC Blood Services follows pathways based on science, logic and ethics. Stated another way, we should attempt to be the voice of reason where less than rationality frequently prevails. In the short run (6 to 12 months) there is little time to develop the science surrounding AIDS. We can, however, take steps in this direction. Logically we must prepare to implement more steps designed to eliminate high risk groups. Ethically we don't belong in anyones bedroom.

I suggest that we work with CCBC and the AABB to design a comprehensive research program focused on the four hot spots of New York, San Francisco. Los Angeles and Miami. Research Program assumptions are: (1) AIDS will continue to grow as a national epicemic; (2) AIDS will be shown to be transmitted by all blood products; (3) it will not be possible to demonstrate the AIDS safety of any blood product for at least 2 years (The incubation period for AIDS is variously estimated at 7 months to 7 years); and (4) the association of AIDS with homosexuals will continue but delate. Program purposes should be to develop specific techniques (e.g. laboratory tests, direct/indirect questions, education) to eliminate groups at risk of transmitting AIDS and determine the relative effectiveness and efficiency of alternative techniques (e.g. demonstrate whether or not direct questions eliminate gays). This is essentially Kelner's "hot spot" approach except that it has a substantially broader scope i.e. the techniques won't be limited to HBc testing. The program should be initiated with baseline data collection within one month while design and negotiation is ongoing regarding other aspects. Also, the faster and more visibly we move, the more of a leadership position we can capture. The program should be designed to begin to yeild results in six months e.g. 3 months of baseline data collection followed by three months of technique application, with results immediately feed into previously developed computer analytic routines.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

The six month time frame is critical in that I believe our current position as announced in the BSD's is a good one, but we won't be able to hold out for more than 6 to 12 conths (as discussed above) unless we have objective evidence to prove that recommended direct questions and 1ab tests don't work. This poses an interesting question on the precise statement of the null hypothesis.

The long term impact should be to enhance our scientific credibility. If we base our policies on scientific/objective information, we should not have to change frequently which I think would be disasterous to our public image (unless the weight of scientific evidence shifts accordingly).

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration Bethesda. MD 20205

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 Blood Donors

TO: All Establishments Collecting Human Blood for Transfusion

The Acquired Immune Deficiency (AIDS) Syndrome has caused serious concern among members of the blood banking community because of the implications for transfusion recipients if this disease is proven to be transmissible by blood or blood products. The major organizations engaged in blood collection have recently reached a consensus as to steps which should be taken to decrease the risk of transmitting AIDS by blood transfusion. Consistent with the recommendations of 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 Biologics is advising all establishments collecting blood for transfusion to institute additional measures designed to decrease blood collection from individual donors and donor groups known to be at increased risk for transmitting AIDS. The following steps should be included:

  1. 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 blood donation because of the potential risk to recipients of their blood. As presently defined this group includes: 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 individuals at increased risk of AIDS. Educational programs should include the individual donor as part of the donor screening procedure.

  2. Re-education of personnel responsible for donor screening should be conducted with special attention to recognition of the early signs and symptoms of AIDS. 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.

*  

Such intravenous drug abusers are already excluded by existing regulations.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. The SOP should specifically inform ataff that all blood or blood products inadvertently collected, or collected for therapeutic purposes, from a donor known or suspected of having AIDS should be considered potentially highly infectious and must be immediately quarantined and disposed of expeditiously 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 Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers and the American Blood Resources Association may be referenced in the licensed establishments' SOP without individual submission to the Office of Biologics. Alternatively, licensed establishments which develop their own procedures should submit them directly to the Office of Biologics for approval concurrent with implementation.

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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):

  1. 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.

  2. 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×
Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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.

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

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

Suggested Citation:"D Key Documents Provided to the Committee." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Get This Book
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During the early years of the AIDS epidemic, thousands of Americans became infected with HIV through the nation's blood supply. Because little reliable information existed at the time AIDS first began showing up in hemophiliacs and in others who had received transfusions, experts disagreed about whether blood and blood products could transmit the disease.

During this period of great uncertainty, decision-making regarding the blood supply became increasingly difficult and fraught with risk. This volume provides a balanced inquiry into the blood safety controversy, which involves private sexual practices, personal tragedy for the victims of HIV/AIDS, and public confidence in America's blood services system.

The book focuses on critical decisions as information about the danger to the blood supply emerged. The committee draws conclusions about what was done—and recommends what should be done to produce better outcomes in the face of future threats to blood safety.

The committee frames its analysis around four critical area:

  • Product treatment—Could effective methods for inactivating HIV in blood have been introduced sooner?
  • Donor screening and referral—including a review of screening to exlude high-risk individuals.
  • Regulations and recall of contaminated blood—analyzing decisions by federal agencies and the private sector.
  • Risk communication—examining whether infections could have been averted by better communication of the risks.
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