HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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5 Donor Screening and Deferral
5 Donor Screening and Deferral
Pages 101-134
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From page 101... ...
By January 1983, the CDC had accumulated enough epidemiological evidence to suggest that the agent causing AIDS was being transmitted through blood and blood products, and also through sexual contact. The evidence also demonstrated that there were several groups in the United States with an increased risk for developing AIDS.
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From page 102... ...
At the meeting, the blood services community first heard preliminary data on the possibility of a transmissible agent within the blood supply. Scientists from the CDC recommended that blood banks implement specific donor screening measures such as questioning donors about their risk behaviors and rurming blood donations through a series of tests, among which the most important was for the hepatitis B core antibody insofar as it occurred in most individuals who had AIDS (Curran, Evatt, Foege, McAuley, Pindyck, Rodell interviews; Foege, 19831.
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From page 103... ...
This meeting is notable for being a second attempt to address the need to implement surrogate tests as a means to Secrete the safety of the blood supply and a second occasion when testing was proposed but not recommended. Explanatory Hypotheses The Committee identified three hypotheses to guide its analysis of the issues of donor screening and deferral: 1.
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From page 104... ...
In 1982 the American Association of Blood Banks (AABB) standards required that each donor meet the following criteria: the donor had to appear in good health, the skin at the venipuncture site had to be lesion-free, the donor should not have received blood or blood components (known to be a possible source of hepatitis)
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From page 105... ...
This meeting was widely publicized, and over 200 people attended, including representatives of the CDC, the FDA, NIH, the National Hemophilia Foundation, the National Gay Task Force, blood banks, and the plasma fractionation industry. While there was a consensus among most plasma and blood collection organizations and PHS agencies that steps should be taken to reduce the risk of AIDS transmission through the blood supply, members of the scientific and medical community disagreed on measures for detecting high-risk donors.
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From page 106... ...
Francis estimated that this deferral process would eliminate over 75 percent of AIDS-infected donors (Francis 1983~. The blood banks (American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers)
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From page 107... ...
Prior to the issuance of these recommendations, donor selection policies (AABB 1982 Standards for Transfusion Services) for both the collection of whole blood and plasma already sought to identify people in the following highrisk groups as being at increased risk of infectious diseases: drug abusers, persons with residence in or recent travel to Haiti, and those with a history of recent treatment with blood products.
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From page 108... ...
The PHS did not recommend directly questioning donors about high-risk sexual behavior nor did it recommend surrogate testing of donated blood (CDC, MMWR, March 4, 19831. Later in March 1983, the FDA notified all establishments collecting source plasma and whole blood for transfusion, and manufacturers of plasma derivatives, of the steps needed to decrease the risk of blood or plasma donation by persons who might be at increased risk of transmitting AIDS.
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From page 109... ...
On December 17, 1982, Alpha Therapeutics had required the exclusion of all donors who had been in Haiti, used IV drugs, or, if male, had had sexual contact with another man. The announcement of this action met with a great deal of opposition from many groups, including the volunteer blood banks and the gay community.
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From page 110... ...
(Confidential unit exclusion involves use of a bar code sticker to label a unit "do not transfuse" or "not for transfusion." See Afterword below.) Although blood banks did not implement direct questioning of donors about their sexual preferences at the same time plasma collectors did, they did comply with the FDA's recommendations issued on March 4, 1983.
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From page 111... ...
. In addition, the blood banks perceived that the gay community might not cooperate if gay donors were rejected on the basis of sexual orientation, and furthermore, that they might donate on purpose or out of spite (Evatt, Silvergleid interviews)
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From page 112... ...
The blood banks saw donor questioning as damaging to donor motivation and possibly counterproductive to risk reduction. Generally, decisionmakers who did not insist upon direct questioning of donors had several reasons: they were unsure of the propriety of asking donors about sexual activities; they did not believe that direct questions would obtain reliable answers from donors about a sensitive issue such as sexual behavior; and they were concerned about the legal and political ramifications of direct questioning (see for example, American Red Cross memo from Dr.
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From page 113... ...
, and a surrogate test for HIV infection was no longer needed. When it was important to know the effect of surrogate testing on AIDS transmission, however, the evidence was inadequate or unpublished.
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From page 114... ...
1991~. At the time, there thus appeared to be within the blood bank community both many who feared for the safety of the blood supply if surrogate testing were implemented, and some who did not view the possibility of an infectious agent in the blood supply as great enough to warrant such testing.
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From page 115... ...
In particular, as stated earlier, blood bank physicians questioned the validity of the CDC data on the correlation of anti-HBc to AIDS cases among a cohort of homosexual who attended an STD clinic. Risk Assessment Erroneous assumptions about the incubation period and the mortality rate for AIDS led to widely differing, inaccurate projections of the outcome of more vigorous donor screening.
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From page 116... ...
Thus, the known costs associated with donor screening interventions seemed to outweigh their benefits, which were unknown but depended on what were still incomplete scientific data. If decisionmakers had known that AIDS had a long asymptomatic period during which people were infectious, they would have had to admit that the risk of AIDS transmission by transfusion was much higher than "one case per million patients transfused" (estimate of the American Association of Blood Banks, the American Red Cross, and the Council of Community Blood Centers, June 22, 1983; see Chapter 3~.
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From page 117... ...
Foege expressed his belief that the meeting had been successful in presenting the most recent data on AIDS and had served as a "forum" for different views to be expressed (Foege 19831. Conclusions Blood banks, government agencies, and manufacturers were unable to reach a consensus on how extensively to screen for high-risk donors in order to substantially reduce the risk of HIV transmission through the blood supply.
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From page 118... ...
In general, anti-core testing showed a 6 percent positive rate in blood donors, a 12 percent positive rate in blood donors who self-excluded, a 70 percent positive rate in gay men, and a 95 percent rate in AIDS patients in STD clinics (Pindyck interview)
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From page 119... ...
The task force reviewed several pilot tests performed at blood banks in high-risk areas. The pilot tests comprised four studies on anti-HBc; two studies
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From page 120... ...
; the test could help reduce the incidence of non-A, non-B hepatitis in recipients of blood products; and blood and plasma collectors had an obligation to do all that was possible to increase the safety of the blood supply. Opposition to Surrogate Testing.
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From page 121... ...
, said that there was not enough evidence that the blood supply could transmit AIDS to restrict donations from male homosexuals. However, in a contemporaneous report of the American Association of Blood Banks, Dr.
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From page 122... ...
became available in 1985 leads to several conclusions, the first of which follows: · When confronted with a range of options for using donor screening and deferral to reduce the probability of spreading HIV through the blood supply, blood bank officials and federal authorities consistently chose the least aggressive option that was justifiable. In adopting this limited approach, responsible officials rejected options that may have slowed the spread of HIV to individuals with hemophilia and other recipients of blood and blood products.
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From page 123... ...
There was, for example, uncertainty about the sensitivity and specificity of anti-HBc antibody screening as a method for identifying high-risk donors, and about the consequences of such screening for the safety of the blood supply. Some observers believed that the test was insensitive and would reduce the availability of naturally occurring antibody against hepatitis B infection.
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From page 124... ...
Interest group politics were also at work in the opposition of the blood products industry to screening for anti-HBc antibody. For the blood banks, and plasma fractionators, this was a matter of dollars and cents, and they used their access to FDA and to the BPAC to make their case.
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From page 125... ...
This lack of confidence seems to have reduced the credibility of CDC's early warnings and led FDA regulators, blood banks, and plasma fractionators to discount warnings presented at the January 4, 1983, meeting. The history of the CDC's handling of the swine flu episode less than a decade
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From page 126... ...
It is hard to imagine an instance in which such interagency disagreement could have contributed to a more unfortunate outcome. The Committee drew another conclusion about organizational influences: · The structure and process of the FDA's Blood Products Advisory Committee (BPAC)
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From page 127... ...
Although participants at the January 4, 1983, CDC meeting did not come to an agreement on actions regarding donor screening, there were several plasma fractionators and blood centers that initiated donor selection and screening interventions that surpassed the recommendations of the blood bank community and federal agencies. The decisionmakers could have defended wide-scale execution of these strategies in two ways: by obtaining information from a broader base of constituents, and by obtaining more information about possible consequences of action or nonaction from representatives of different theoretical premises regarding the epidemiology of AIDS.
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From page 128... ...
, who in turn are tested for HIV. Donor deferral lists have been used in the blood banks since the 1970s regarding donors positive for hepatitis B surface antigen (HBsAg)
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From page 129... ...
Without any evidence that the causative agent would soon be elucidated, surrogate tests were suggested. Based on previous studies and new evidence, the surrogate testing for non-A, non-B hepatitis was instituted during 1986-1987 by using both the ALT and Anti-HBc tests.
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From page 130... ...
This is the fourth opportunity to selfdefer. Any unit of blood found positive for any of the tests is destroyed and the donor is permanently deferred by being placed in a computer database (American Red Cross Blood Services 19941.
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From page 131... ...
323; 1990. American Association of Blood Banks, American Red Cross and Council of Community Blood Centers.
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From page 132... ...
American Association of Blood Banks; 1994. Dodd, Roger.
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From page 133... ...
Seroprevalence and Epidemiological Correlate= of HTLV-1 Infection in U.S. Blood Donors.
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