HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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6 Regulations and Recall
6 Regulations and Recall
Pages 135-168
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From page 135... ...
In an industry in which company and product reputation is critical to market success, the FDA's collegial and informed approach is usually effective. This chapter presents an analysis of the FDA regulation of blood and blood products during the study period 1982-1986, when the HIV virus began to threaten the integrity of the blood supply and before tests and procedures were established and disseminated sufficiently to control, if not virtually eliminate, that threat.
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From page 136... ...
The section immediately below introduces the framework of analysis: critical events, related regulatory policy questions, and explanatory hypotheses. FRAMEWORK OF ANALYSIS Critical Events The history of the threat that HIV infection posed to the safety of blood and blood products, and the eventual suppression of that threat through the combination of private and public actions, can be told from numerous perspectives.
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From page 137... ...
Critical Event 4 By 1985, there was wide consensus that transfusion of HIV-infected blood products led to HIV infection in the transfusion recipient (Goedert and Gallo 1985; Curran, et al.
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From page 138... ...
In 1988, a presidential directive to the Department of Health and Human Services was issued on blood safety based on the report of the Presidential Commission on the Human Immunodeficiency Virus. The Department was instructed to formulate a policy for tracing recipients of possibly infected blood products ("lookback")
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From page 139... ...
Just as the establishment of most scientific fact is based on the development of a consensus view, so the appropriateness of regulatory action in relation to blood and blood products often operates by consensus. To the extent that the FDA can establish a collegial consensus on the state of scientific knowledge and on the appropriate actions to be taken to protect the public health given that knowledge, it can be assured both that its regulatory actions will be perceived to be well-considered and that they will be largely self enforcing.
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From page 140... ...
Many of the questions that have been raised about the FDA's activities concerning the protection of the blood supply and blood products from contamination by HIV relate to the informality and tardiness of the FDA's regulatory actions (Donohue, Evatt, Feldman, Lipton, Rodell interviews)
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From page 141... ...
Explanatory Hypotheses Me Committee developed operating hypotheses that attempt to take account of the legal authority of relevant actors, the information available in particular time periods, the countervailing public health considerations that bore on particular decisions, the resource limitations that constrained particular actors, the institutional culture and structure within which decisions were made, and the economic and political incentives that bore on decisionmaking. Our general working hypotheses are captured in the following five explanatory propositions that at least in theory can be "applied to" or "tested against" particular regulatory actions or inactions: 1.
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From page 142... ...
The letters recommend slightly different requirements. The requirements recognize the differing positions of whole blood collection centers, plasma collection centers and plasma fractionators in the collection and distribution of blood and blood products.
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From page 143... ...
Because these letters asserted that they were based upon a consensus of the collection centers and the plasma fractionators, the Committee believes that the letters suggested that these practices were ongoing at most, if not all, blood collection centers and blood products manufacturers at the time that the letters were issued. Analysis The Committee has not been able to determine definitively what the intended legal effect of these letters was or precisely how the letters were understood by their recipients.
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From page 144... ...
There was grave concern in the whole blood collection and plasma fractionation industry, as well as in the medical profession and among patient groups, that sufficient blood and blood products remain available for necessary treatment. A recall of existing stocks could have seriously disrupted the availability of necessary therapeutic agents.
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From page 145... ...
The action was in the public health tradition of teamwork among multiple actors, both public and private. Moreover, because there was no consensus at this time, an appropriate trade-off between risk of infection and product availability with respect to blood and blood products that might possibly be contaminated with the AIDS virus, a recall may have seemed self-evidently premature.
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From page 146... ...
Plasma fractionators and collection centers might thus easily have responded to them in quite different ways. Second, there is no indication that donor screening triggered serious analysis of what to do about a possible recall or withdrawal of already collected plasma or manufactured AHF concentrate.
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From page 147... ...
was devoted to the question of what was known about AIDS and its transmission through the blood supply, and what BPAC should recommend to the FDA concerning recalls (FDA, BPAC 1983; see also Chapter 3~. The National Hemophilia Foundation seems to have been the only participant at the BPAC meeting that supported the automatic recall of any product that was found to have been manufactured with plasma taken from a person subsequently determined to have AIDS or to have had characteristics strongly suggestive of AIDS.
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From page 148... ...
Moreover, these scientific disputes were in evidence elsewhere on the public record. For example, in testimony before the House Intergovernmental Relations Subcommittee in early August 1983, Assistant Secretary for Health Edward Brandt stated that AIDS was believed to be transmitted through blood and blood products (U.S.
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From page 149... ...
Moreover, this policy would have been adopted in a situation in which the disease that it would prevent had not been firmly established to exist, the etiology of the disease was unknown, its transmissibility through blood and blood products was not established, and, if established, it suggested a risk of one infection in one million transfusions. Looked at in that light, public health clearly did not demand the adoption of an automatic recall policy.
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From page 150... ...
Nor was there serious consideration of how collection and pooling might be managed to avoid the realization of this doomsday scenario in the future. Moreover, while there was still disagreement in the scientific community about the existence, etiology, and transmissibility of AIDS, those who disagreed with Assistant Secretary Brandt's testimony to the Intergovernmental Relations Subcommittee were in a distinct minority (Bove 1983; Osborn interview)
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From page 151... ...
Indeed, no latency period had been established for AIDS and it is not obvious how anyone could rapidly determine how much AHF concentrate from a particular donor was still in stock or what proportion of existing stocks it represented. Because there was no established system of tracking the health of blood donors, the Committee is puzzled by how plasma fractionators were to learn that a donor had AIDS.
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From page 152... ...
The hypothesis that the FDA lacked the resources to engage in stronger regulatory action cannot be rejected. On the one hand, the policy that the agency adopted was more resource-intensive from the agency's perspective than either an automatic recall policy or a blanket ban on further production and distribution of AHF concentrate.
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From page 153... ...
It seems important to stress once again that these conclusions are being offered with the benefit of 20/20 hindsight focused on an incomplete record of -the events. Had AIDS turned out not to be a viral disease capable of transmission through blood products, an FDA that had eliminated the availability of AHF concentrate in midsummer 1983 would have been at least as politically vulnerable as the FDA that had banned saccharin on the basis of good scientific evidence and a mandatory legal requirement only a few years earlier, or that had moved rapidly to develop a swine flu vaccine.
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From page 154... ...
In October 1984, the CDC announced that preliminary evidence concerning the effects of heat treatment on the viability of the AIDS virus was strongly supportive of the usefulness of heat treatment in reducing the potential for transmission of the AIDS virus in AHF concentrate and suggested that the use of non-heat-treated AHF concentrate should be limited (CDC, MMWR, October 1984~. Most people accepted the model virus studies on
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From page 155... ...
1985~. The CDC, in cooperation with Cutter Biological, conducted a study in which the AIDS virus was added to Factor VIII concentrate and was subsequently heat treated.
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From page 156... ...
It is not clear, for example, exactly how great the economic or political costs would have been to plasma fractionators and to the FDA to remove untreated AHF concentrate from the market more rapidly. The Committee has only fragmentary information about how rapidly untreated AHF concentrate was removed through manufacturer's voluntary efforts or about what FDA action would have added to the rapidity of its removal.
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From page 157... ...
The plasma fractionation industry seems to have perceived clear advantages to developing a workable heat treatment process and to have rapidly secured approval for different processes (Hammes pers.
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From page 158... ...
However, despite a 1988 presidential directive to the Department of Health and Human Services to formulate a lookback and notification policy for tracing the recipients of possibly infected blood products, the FDA did not issue recommendations until September 1991 (FDA, BPAC l991a,b)
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From page 159... ...
In 1988, the Department of Health and Human Services received a presidential directive to implement actions in response to blood safety issues raised by the report of the Presidential Commission on the Human Immunodeficiency Virus Epidemic. One issue was prompt notification of individuals who are at increased risk of HIV infection but are unaware of their increased risk (Presidential Commission on the Human Immunodeficiency Virus Epidemic 1988~.
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From page 160... ...
The Committee has found no evidence to suggest that resource constraints prevented action. A lookback and notification policy would primarily burden local blood centers, which would have responsibility for tracing recipients of blood or blood products that had been transfused any time within five years of the donor becoming aware of his or her HIV infection.
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From page 161... ...
In connection with the AIDS contamination of the blood supply, there was little basic biomedical knowledge on HIV and AIDS and the rapid development of new knowledge was extremely valuable. Once the AIDS virus had been isolated, events moved very rapidly toward effective screening and treatment of blood and blood products.
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From page 162... ...
. Ironically and tragically, plasma fractionators were not encouraged by government to aggressively produce and market heat-treated AHF concentrate a year before scientific proof that heat treatment killed HIV, but they moved rapidly to provide that product once it became plausible to believe that heat treatment was effective against HIV.
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From page 163... ...
Achieving this sort of balance in the system motivates the Committee's recommendations for restructuring the blood regulatory process (see Chapter 8~. TO ADVANTAGES OF MARGINAL THINKING The FDA had several opportunities to take actions that appear to have had little or no risk for causing net harm and some possibility of reducing the number of people who contracted HIV infection through blood or blood products.
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From page 164... ...
Destruction of Potentially Contaminated Cryoprecipitate Blood banks freeze cryoprecipitate from single donors and store it until the time of use. The FDA could have required blood banks to check their stores of frozen cryoprecipitate and destroy units obtained from donors subsequently found to have AIDS.
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From page 165... ...
, they began to face the problem of having two classes of blood and plasma: tested, which was presumably "safe," and untested, which had a higher risk of containing HIV. The FDA could have required blood and plasma collection centers as well as plasma fractionators to test each unused unit for HIV and discard positive units.
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From page 166... ...
Blood Products Advisory Committee, July 19, 1983. Food and Drug Administration.
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From page 167... ...
Presidential Commission on the Human Immunodeficiency Virus Epidemic. Report of the Presidential Commission on the Human Immunodeficiency Virus Epidemic.
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From page 168... ...
168 ~ ~ ~- Sag O.S. Governmcnl Printing Ounce.
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