Emergence Of HIV In US Blood Supply
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The emergence of HIV in the U.S. blood supply: Organizations, obligations, and the management of uncertainty
KIERAN HEALY
Princeton University
In the early 1980s, blood suppliers in most Western nations went
through at least a crisis, and often a scandal. Thousands of people
were infected with HIV after receiving a blood transfusion or some
other blood product. Blood-borne AIDS, like the AIDS epidemic as a
whole, was a human tragedy. It was also an organizational disaster. If
we want to understand what happened, the experience of the United
States provides a particularly important starting point. It has the
largest blood industry in the world. Unusually, a non-pro┬уt whole
blood sector that relies on voluntary donations coexists with a large,
for-pro┬уt plasma industry that buys its raw material from suppliers.
Almost the same volume of raw plasma is purchased as whole blood
is donated each year. In retrospect, the blood industry in the U.S.
between 1981 and 1983 provides a kind of natural experiment that
allows us to test and develop our ideas about the social embeddedness
of economic transactions, and the reactions of complex organizations
to uncertainty.
This article seeks to explain why blood banks and plasma companies
reacted di┬нerently to the same information about the spread of a new
disease through the blood supply in the United States. I draw on recent
work in economic sociology and the sociology of risk in order to give
an account of these events. Using the concept of a ``negotiated infor-
mation order'' to frame the analysis, I explain why blood banks and
plasma companies acted as they did.
1
The appearance of blood-borne AIDS was an instance of an awkward kind of uncertainty. Actors in the blood industry were not sure what was going on, and the available information was ambiguous. They constructed a set of standards, an information order, to evaluate information about the problem. Drawing
Theory and Society 28: 529^558, 1999. ├ѓ 1999 Kluwer Academic Publishers. Printed in the Netherlands.
Page 2
on statements made to a commission of inquiry, as well as internal
memos, minutes, and transcripts, I show that these standards were
in┬ъuenced by three factors: the external dependencies of these organ-
izations, the exchange relations that bound them in di┬нerent ways to
their suppliers and recipients, and the organizational ties that linked
them to other stakeholders in the blood industry.
Titmuss's argument was the main article of faith that the U.S. blood
supply rested on from 1974 to 1981. Understanding where Titmuss
erred provides a useful starting point for an empirical account of the
AIDS disaster of the 1980s, as well as an entre┬їe to the theoretical issues
at stake. The legacy of The Gift Relationship
Titmuss compared the social organization of the blood supply in England and the United States. He argued that the then largely commercial,
market-driven system of the United States was demonstrably inferior
to England's voluntary system. In the United States, hepatitis was a
chronic problem in the blood supply, whereas in England it was almost
entirely absent. Titmuss claimed that if blood is a commodity, indi-
viduals will have an incentive to lie about their health. Unsuitable
suppliers come forward and are paid for a bad product. The people
most likely to sell their blood are also those most likely to transmit
disease. (Titmuss referred to them as ``skid row'' suppliers.) In addition
to contaminating the supply, these commercial blood suppliers tend to
drive volunteer donors away. By contrast, in an altruistic system there
are no such incentives to lie; thus no one from ``skid row'' will donate
blood and the supply will stay clean. In addition ^ and ultimately most
important ^ altruism is morally better for society than the market.
Markets are both ine┬сcient and morally bankrupt. If blood remains a
gift, then the system will stay e┬сcient and the bonds of community will
remain strong.
2
It also had a remarkable influence
on blood policy. A few economists objected, but for once they were
ignored.
3
In 1973, the Assistant Secretary for Health announced the National Blood Policy, which recognized that reliance on ``commercial sources of blood and blood components for transfusion therapy has contributed to a signi┬уcantly disporportionate incidence of hepatitis, since such blood is often collected from sectors of society in which transmissible hepatitis is more prevalent.''
4
The National Blood Policy
aimed to eliminate pernicious commercialism in the blood supply by
instituting an all-volunteer system for the collection of whole blood.
There are many problems with Titmuss's argument. The book is a
strong mix of empirical facts and moral charges. From the perspective
531
of economic sociology, it is an exemplary case of what Zelizer calls the ``boundless model'' of markets.
5
The market is seen as a voracious entity liable to eat up whatever it can get its hands on. In a market society, everything becomes commodi┬уed and can be put up for sale. Important social relationships are destroyed. The only defense against the market is the ``legal preservation of selected items or activities outside of the cash nexus.''
6
Some things ^ blood, for instance ^ should be kept sacred. Zelizer notes that, although motivated by a deep disgust with the evils of the market, these critics nevertheless accept that markets really are laws unto themselves, unbeholden to any social or cultural dampers. They do not accept the possibility that, once set loose, the logic of the market might still be inhibited or de┬ъected by other institutions. By contrast, more recent writing has tended to stress that markets are related in complicated ways to other features of economic, cultural, and social structure. Markets are ``em- bedded'' in networks, subject to organizational and state interference, and a┬нected by culture.
7
Titmuss's argument about blood and the market assumes two impor-
tant things. First, there must be a clear way to link an organization's
form to the quality of the blood it procures. We can isolate some
mechanism that ensures that the one will a┬нect the other. Second, this
link is unmediated by any other factors. Market logic or altruistic virtue
will always have their respective e┬нects. Thus, the market has a direct,
unequivocally negative e┬нect upon the quality of the blood supply.
Both of these assumptions are false. The link between organizational
form and clean supply exists, but it is contingent. Both market and
altruistic arrangements are embedded within social structure and cul-
ture. I now have to justify these assertions in turn. The ┬уrst point can
be argued for brie┬ъy. Defending the second will mean giving a positive
account of the empirical relationships involved, drawing on concepts
and theory from economic sociology and the sociology of risk.
Do good gifts mean clean blood?
Titmuss was right to argue that, in the United States, payment for
blood attracted people who contaminated the supply. But he was
wrong to suggest that contamination occurred because they were
paid. Titmuss was able to con┬ъate these claims because he was mainly
concerned with the hepatitis B virus (HBV). This was indeed prevalent
532
amongst the supply population in the United States at the time. But, as has been pointed out by several commentators, this does not mean that we can assume that the price mechanism will always attract dirty blood.
8
Whether it does or not will be contingent upon the overlap of
blood-selling and disease-bearing populations. These commentators
note that some countries (such as Sweden) or hospitals (like the Mayo
Clinic) pay their suppliers and still manage to have a clean supply, but
the underlying argument that makes these examples relevant has not
been clearly made.
9
Titmuss was lucky on both these counts. With one signi┬уcant risk and no reliable test for it, he was able to assess the e┬нectiveness of markets versus altruism as mechanisms for reducing that risk. The test of organizational e┬сciency was obvious: all one had to do was examine the prevalence of hepatitis amongst transfusion recipients. But this was an e┬нective performance index only because of the unusual circum- stances. Some of Titmuss's critics saw through this problem. They pointed out that the issue was not simply whether you paid for blood, but rather whether the person you paid had hepatitis.
10
If we had a di┬нerent way to get information about supply quality ^ through epidemi- ology, or accurate tests ^ then it wouldn't matter whether suppliers were paid or not, since we would not be relying on that mechanism to reduce the risk borne by the system. 533
Page 6Once we recognize that the relation between the social organization and the cleanliness of the supply is contingent, it is easy to see why neither voluntary nor price mechanisms can generally ensure anything about the quality of supply in cases where we do not know about a bloodborne pathogen. Titmuss's argument is then greatly weakened. It amounts to saying that when we know that a disease is chronic in the population we buy blood from, then our blood supply will be dirtier than if we relied on voluntary donors who do not have the disease. This is not saying very much. Sweden and the Mayo Clinic make the same point. If Sweden has a naturally low rate of hepatitis across its popula- tion, or if the Mayo Clinic carefully screens all its donors, then it doesn't matter if the suppliers are gift-givers or money-grubbers. In spite of these ┬ъaws, Titmuss had the kind of e┬нect on government policy that most social researchers only dream about. Both the United States and the European Union are presently committed to an altruis- tic supply system, and Titmuss is usually cited as the inspiration in both cases.
11
It is therefore surprising that so little has been written
about the e┬нects of this change. For the great irony of The Gift Rela-
tionship is that its success helped create the conditions that allowed
its argument to be turned upside down. In the case of AIDS, a pop-
ulation of responsible, voluntary donors happened to be co-extensive
with a large chunk of the disease-bearing population. The blood banks
knew homosexual men to be reliable givers and good volunteers. As it
turned out, they were also important vectors for HIV. The voluntary
system ended up attracting people who contaminated the supply. But,
as with commercial donors and hepatitis, they contaminated the sup-
ply not because they were donors, but because they had HIV. Titmuss's
system ended up selecting the wrong people in much the same way as
the previous market arrangement had selected the wrong people: by
accident.
ignore the potential for uncertainty. The U.S. blood supply managed to do so for about seven years. Then something new showed up and the system failed to deal with it. Titmuss's work remains a touchstone for those, like the blood bankers, who argue that the blood supply ought to rely exclusively on voluntary donation. It is therefore important to see clearly the ways in which it is limited or wrong. But if we want to understand what happened to the supply in the early 1980s, we need a better theory than Titmuss can provide. Zelizer urges that a course be charted to ``capture the complex interplay between economic, cultural and social factors'' in the study of economic institutions.
12
The events of 1981^1983 give us an oppor-
tunity to examine this interplay in the case of the blood banks and
plasma companies.
How the U.S. blood supply works
Getting blood or plasma out of one person and safely into another is a
complicated business, and at present the people of the United States
have two different kinds or organizations to do this job for them. First,
there are the blood banks (including the Red Cross). They obtain al-
most all of their supply from voluntary donors.
13
They process and then distribute freely donated blood. They charge hospitals for their services, but they are non-pro┬уt organizations. Every year in the United States about 14 million units of blood are donated to these organizations. The American Red Cross collects about 45 percent of the total, blood banks about 42 percent, hospitals 11 percent and the small remainder is imported.
14
These donations are processed into di┬нerent blood products: whole blood, plasma, clotting factors, and 535
Page 8
others. About 3.6 million people receive transfusions of these products
every year. Blood banks generally enjoy local (geographical) monopo-
lies. They do not compete with one another.
15
There are four U.S. based compa-
nies. These organizations process plasma and sell it to those people ^
mainly hemophiliacs ^ who need it. There is a competitive market for
plasma products.
16
It would be highly impractical for an individual to negotiate a blood
transfusion for herself. Individuals do not have the time, money or
expertise to obtain blood and monitor its quality. Instead, they rely on
these organizations to do it for them. By doing so, they hope that the
organization involved will minimize the risks involved in the trans-
action on their behalf. When there is good information about risks,
this process is reasonably straightforward. Most blood is processed
and delivered safely.
17
Despite this, the blood organizations were nevertheless 536
Page 9
obliged to make decisions, and act on the basis of the information they
had. I o┬нer an explanation for why, when they were faced with the
same uncertainties and armed with the same information, the blood
banks and the plasma companies reacted in di┬нerent ways.
At ┬уrst blush, it seems that the blood banks reacted very badly: they
played down the extent of the risk, they claimed that the evidence did
not show conclusively that HIV was a blood-borne disease, and they
refused to screen out potentially infected donors. By contrast, the
plasma companies accepted that there was a good chance that HIV
was being transmitted by their products, they moved very quickly to
switch the source of their supply, and introduced new methods to
inactivate viruses in plasma derivatives. But these positive moves were
mitigated by decisions to keep older product batches on the market,
and commercial plasma ended up infecting more people than did
donated blood. Both the banks and the companies fell, but at di┬нerent
hurdles.
Organizations, risks, and disasters
There is a huge literature on the AIDS epidemic, but almost none of
it deals with the blood industry. Relevant commentaries tend to fall
into one of two categories: either they ignore the distinction between
the commercial and non-commercial parts of the system or, with the
bene┬уt of hindsight, they tell the story in a whiggish way, with those
who were in the right cast as heroes from the beginning.
18
Sapolksy and Boswell's brief characterization of the structural di┬нerences be- tween the banks and the companies stands out as a rare attempt to explain their di┬нerent reactions.
19
They argue that the plasma compa-
nies reacted better because they were market-driven organizations with
a competitive interest in selling a demonstrably safer product, whereas
the blood banks wished merely to protect their quiet monopolies. This
goes some of the way toward a satisfactory explanation. But Sapolsky
and Boswell tend to argue for the general superiority of markets, much
as Titmuss supported the opposite view.
industry can help us sharpen our general theories of organizational responses to uncertainty. The literature in this ┬уeld can roughly be divided into three varieties.
20
The ┬уrst kind focuses on individual risk assessment and the social construction of risk objects. Experimental work by Kahneman and Tversky (and others) shows that individuals are not good judges of risk. If given choices between outcomes, with probabilities attached, people do not calculate expected values as decision theory says they should. Instead of doing a straightforward calculation, they draw on rules of thumb (``heuristics'') that systematically bias their choices.
21
This experimental work shows how individuals can be made to mis- perceive risks in di┬нerent ways. Sociologists taking up this perspective became interested in what happened outside of laboratory settings. In particular, they were interested in why some risks were perceived as such and others were not.
22
The question here is why particular ``risk
objects'' ^ seat belts on school buses, drunk drivers, tamper-proof
medicine bottles ^ emerge from an ocean of potential candidates to be
socially constructed as real dangers. In general, the risks studied are
small. Often, the research question is precisely why people bother to
worry about them at all.
23
The AIDS disaster re┬ъects aspects of both these problems, but falls
somewhere in between them. The blood industry had to decide whether
the data they had meant a real ``risk object'' existed, and they had to
react to a disaster as it happened. But the data were not good, and the
catastrophe occurred silently and in slow-motion. The blood industry
was not so much constructing a risk object or reacting to an accident,
as deciding whether a disaster was happening around them.
planned for. When outcomes are known to be possible but there is little or no information about the probabilities involved, an organization is simply uncertain about the the future. Research and theory suggest that organizations (and institutions more generally) are important to questions of risk and uncertainty for three reasons. First, the public does not construct the risk objects they worry about, organizations do. Organized interests ``devote sustained attention to constructing facts and machines, laws and regulations, organizations and management systems, risk objects and networks for controlling them.''
24
Second, as well as dealing with risk, organizations are complex systems that pro- duce their own risks and uncertainties in the course of their day-to-day operations.
25
Third, the most common reason o┬нered for organiza- tional failure or inadequate response ^ human error ^ is hopelessly inadequate when it comes to explaining the way an organization be- haved before and after a disaster.
26
The sociology of risk and uncertainty, then, focuses on discovering ``how organizational interests in┬ъuence information classi┬уcation and interpretation, how information is used by responsible organizational elites and by contending elites within organizations, the degree to which technical elites and managerial elites are autonomous or inter- dependent and the symbolic roles of technical information.''
27
The blood industry's information order It is easy to say that interests are important, or that the relationships between organizational elites matter.We need to be more speci┬уc, both theoretially and empirically. In explaining the decisions of the blood banks and plasma companies, I draw on Carol Heimer's concept of a ``negotiated information order'' to show how structural interests, exchange relationships, and organizational ties shaped the decisions that the blood industry made about AIDS.
28
Heimer studied how oil rigs in the Norwegian re┬уning industry get insured. Drilling for oil in the North Sea is dangerous. As a relatively new enterprise, ``experience-based information, usually the basis for decision making in marine insurance, was unavailable ... there were no data about what the losses were likely to be.''
29
To turn these uncer- tainties into insurable risks, the insurers and drillers developed a set of standards and routines for evaluating the information they had. Following Feldman and March, Heimer points out that the standards 539
Page 12for knowing something to be true vary by institutional setting: ``[W]hen several actors are required to carry out [a] decision, then the problem is not so much to get evidence to answer the question, but to get information that everyone concerned will agree is evidence. That is, the information needs to be socially su┬сcient as well as technically su┬сcient.''
30
The ``negotiated information order'' is the set of criteria for the social su┬сciency of information. It is partly determined by the interests and bargaining power of the participating organizations. Heimer's re┬уners and insurers had a well-worked-out set of rules, a stable information order. This was partly because they were oriented toward solving the problem of insurance from the beginning. In the case of the blood supply, the blood banks and plasma companies had to negotiate an information order on the ┬ъy, as they gradually became aware of the uncertainties they faced. The result was open con┬ъict over the social su┬сciency of the data they had. As we shall see, some players could look at the available information about transfusion AIDS and say ``How many more cases did they need?'' whereas others just saw ``i┬нy'' cases and ``soft and squiggly data.''
31
The decision process ^ and
the resulting information order ^ was shaped by the interests of those
involved. It is not obvious what those interests were. What led the
blood banks and plasma companies to act as they did? I argue that
three factors were decisive: the external dependencies of the major
players, the exchange relations that these dependencies were embedded
in, and the organizational ties that linked the industry to other inter-
ested groups.
External dependencies
As I have said, we can think of the blood banks and the plasma
companies as organizations that mediate between suppliers and re-
cipients of blood and blood products, calculating risks and dealing
with uncertainty as they go. When a problem like AIDS comes along,
the organization needs criteria to evaluate it. One option is to under-
stand it in terms of its possible e┬нects on suppliers and recipients. If
there is a con┬ъict of interest between these groups, an organization will
move to protect the constituency it is externally dependent upon.
32
540
Page 13
The blood banks and plasma companies had di┬нerent dependencies.
For the banks, suppliers were relatively more valuable than recipients.
Given a choice, blood bankers would much rather have a new supplier
than a new transfusion recipient. Suppliers are relatively rare. Recipients
are all too common. Given the same choice, plasma companies would
much rather have a new recipient than a new supplier. In cases where
the organization is caught in a con┬ъict of interest between suppliers
and recipients, it will tend to side with the constituency most valuable
to it. The blood banks had a hard time ┬уnding and keeping donors, but
they had plenty of recipients for these gifts at the other end. The plasma
companies had a more or less stable population of recipients ^ deter-
mined in part by largely uncontrollable factors like the prevalence of
hemophilia ^ that was much smaller than the population of potential
suppliers. Their interests pointed to di┬нerent constituencies.
Exchange relations
Interests are generally understood as forces that striaghtforwardly in-
form decisions. The concept of external dependence is a useful way to
grasp the structural basis of organizational interests. But I argue that,
in this case, the exchange relationships that linked organizations to
their suppliers and recipients in┬ъuenced their actions independently of
their interests. The external dependencies were embedded in a set of
norms and expectations of exchange that either dampened or exacer-
bated them. In our case, the organization structurally dependent upon
suppliers obtained units of blood as voluntary gifts. By contrast, the
organization structurally dependent upon recipients contracted with
its suppliers and sold its products in a competitive market. The social
obligation of the blood banks to their suppliers reinforced their de-
pendency. If nothing else, Titmuss showed that making blood a gift
tends to sacralize it, placing the receiver in a debt of gratitude to the
supplier. The Red Cross had drawn on this powerful cultural notion of
gift-giving for years, in an e┬нort to create a moral community of
dedicated givers. The blood banks joined them after 1974. Having a
gift relationship with their suppliers made it very di┬сcult for the blood
banks to treat them in certain ways, including rejecting their gift or
directly questioning its provenance. No such bonds existed between the
plasma companies and their suppliers or recipients. In the case of
plasmapheresis, contract and payment de┬уne and discharge the obli-
gations of the transaction, leaving all parties free of any further re-
sponsibilities.
541
I argue that the consequences of each organization's structural de- pendencies were channeled through the exchange relations it had with those it dealt with. This is an important part of what it means to say economic interests and actions are socially embedded.
33
Suppliers can
merely be suppliers, or they can be donors. Recipients can be patients
or customers, and so on. When it comes to understanding why
particular decisions were made, the structural dependencies and the
exchange relations are analytically separable from one another, and
have independent effects.
34
The blood banks and plasma companies were externally dependent
on their respective suppliers and recipients. This dependency mainly
de┬уned their interests, but was itself embedded in a social relationship,
in this case either gift-giving or market pricing. The structural and the
social relationship were closely related, and variation in the one would
most likely a┬нect the other. But they remain separable, and need not
push in the same direction. Embeddedness is the further shaping of
structurally-driven interests and goals by social relations and expect-
ations.
Organizational ties
Finally, the blood banks and plasma companies were themselves
situated in important relationships with other organizations. These
542
include government agencies, health authorities, the medical profes- sion and groups representing suppliers and recipients. In each case, the kind of relationship that exists will a┬нect how the organization interprets new information. I focus on two organizations that signi┬у- cantly a┬нected responses in each case. The blood banks' decisions were in┬ъuenced by their relationship with gay rights groups and the Centers for Disease Control (CDC).
35
Links to the medical profession and the
National Hemophilia Foundation (NHF) were both important in the
case of the plasma companies. In the former case, the blood banks'
attitude toward gay rights groups and the CDC tended to encourage
the conservative and defensive stance they were already inclined to take.
In the latter, the initially positive response of the plasma companies
tended to be signi┬уcantly watered down by the mediating in┬ъuence of
physicians and the NHF.
Data sources
The data for this article come mainly from an archive held at the
library of the National Research Council (NRC) in Washington, D.C.
In the wake of the HIV disaster, activists and critics of the blood and
plasma industry campaigned for a full Senate investigation of the HIV
diaster. This demand was denied. Instead, in 1994 the Government
directed the Institute of Medicine to investigate the matter. They held
some public hearings and invited interested parties to submit argu-
ments and information to them. However, they conducted all their
interviews with blood industry executives in private. In addition to
interviews, they obtained access to internal memos, the minutes or
transcripts of meetings, and other previously con┬уdential documents.
The committee published its report in 1995.
The archive at the NRC contains copies of all of the documents
received by the committee, as well as the notes made during face-to-
face or telephone interviews with the principal players. These notes are
not transcripts, though they often contain verbatim statements from
interviewees along with summaries, paraphrases, and observations by
the interviewer. Apart from the committee's own report, these data
have not been analyzed before now. It is the best available window into
the events of the period.
36
The bulk of the information in the NRC archives concerns the internal workings of the Red Cross, the blood banks, plasma companies, and 543
Page 16the National Hemophilia foundation. In addition to these data, I also draw on the o┬сcial transcript of the public hearings held by the committee in September of 1994. This meeting heard evidence from the victims of the disaster, mainly hemophiliacs and their families.
37
The blood banks: Defending suppliers
This was how things stood in 1981. In the case of non-profit blood
banks with voluntary donors, the recipient bore the risk of receiving
dirty blood. The recipient trusted the bank to minimize that risk, but
the bank bore no liability for passing contaminated products to the
recipient. The law said blood was a service, not a product, and the
banks could not be sued for supplying bad blood. Strictly speaking, the
supplier bore no risk either. Blood is a gift that is safe to donate, and
donors are not culpable for any poisoned gifts they may hand over.
Of course, the blood banks had no interest in actually killing their
recipients, so they tried to ensure a safe supply. There was a problem
with transfusion hepatitis that was controllable but could not be
eliminated. The banks were both externally dependent upon their donors
and obliged to them for their gift. Only about eight percent of
eligible donors give blood in any one year, and the number of regular
donors is a much smaller number again.
38
The gay community was known to supply good donors, having been drawn into the system in the 1970s during the e┬нort to develop a vaccine for hepatitis B.
39
This
meant that, in the case of the blood banks, the risk-bearers (recipients
of transfusions) were different from the people the blood banks were
obliged to and reliant upon (blood donors). This imbalance had serious
consequences for recipients.
40
Evidence of blood-borne AIDS transmission began to appear in De- cember 1981.
41
A small number of hemophiliacs were found to have the 544
Page 17same sort of immune-suppressive disorder that had been seen in homosexuals and recent Haitian immigrants. By August or Septem- ber of 1982, epidemiologists at the Centers for Disease Control were su┬сciently convinced that people were being infected by transfusions to suggest the blood banks not accept high-risk donors. In December 1982, the ┬уrst fully documented case of AIDS by transfusion was reported. Bruce Evatt, an epidemiologist with the CDC, began to present the data he had collected to various interested parties, includ- ing the Blood Products Advisory Committee (BPAC) of the Food and Drug Administration (FDA). On January 4th 1983, the CDC held a public meeting at their headquarters in Atlanta. Representatives at- tended from the FDA, NHF, the National Institutes of Health, the National Gay Task Force, plasma fractionators, and blood suppliers. At the meeting, Bruce Evatt and James Curran presented their data and conclusions about the new disease and made a number of recom- mendations. Evatt had data on seven cases of transfusion AIDS, cases where it seemed that the victims (for example, small children) could only have contracted the disease through blood transfusions they had received. On the basis of these cases, the CDC recommended that blood banks and plasma fractionators screen out homosexual donors and implement a surrogate test for the virus they believed must be the cause of AIDS.
42
The organizations involved now had to decide what to do with this information.When asked about it during the 1994 investigations, those who attended turned out to have widely di┬нering recollections of the conduct of the meeting, the e┬нectiveness of Evatt's presentation, and the strength of his data. Evatt himself remembers being ``stunned and depressed'' by the response he received.
43
Blood bank representatives reacted by denying that the evidence
was conclusive. Dr Aaron Kellner, President of the New York Blood
Center, said ``There are at most three cases of AIDS from blood
44
A program of donor screening would cost money, and false positives would mean that a lot of good blood would be thrown away. Dr Joseph Bove, director of the blood bank at Yale University Hospitals and chair of the FDA committee on blood safety, said, ``We are contemplating all these wide-ranging measures because one baby got AIDS after a transfusion from someone who later came down with AIDS and there may be a few other cases.''
45
Later, blood bankers admitted that there 545
Page 18was a risk, but claimed that it was less than one-in-a-million trans- fusions. Note that claims of this sort, about the likelihood of contracting AIDS through transfusion, were not based on statistical risk assessment in any formal sense. There weren't enough data to do this kind of analy- sis. In an interview in 1994, Jay Epstein of the FDA noted in retrospect that those who thought the objective risk was low had ``no scienti┬уc basis for that belief.... Instead of operating under the assumption of an unknown risk, they operated under a low risk assumption.'' Dr. June Osborn attended the January 4th meeting. She noted in her inter- view that she did not believe a formal model of cost versus risk was formulated until after 1985, when the ELISA test for HIV came into use.
46
Although the vocabulary was the same, the language of risk was socially rather than technically grounded. Mary Douglas has made this argument in her work on risk and culture. As she suggests, phrases like ``bene┬уts and risks'' were used by the blood industry ``in an antique mode ... to legitimate policy or discredit it.'' Douglas argues that ``[t]he neutral vocabulary of risk is all we have for making a bridge between the known facts of the world and the construction of a moral com- munity.''
47
In January of 1983, the blood banks issued a statement saying they did not want to ask people about high-risk sexual practices. They had ethical objections to limiting voluntary donation from high-risk groups, saying that ``direct or indirect questions about a donor's sexual preference are inappropriate.''
48
They did encourage autologous dona- tions, especially in elective surgery.
49
The overriding reaction, as we would expect, was to deny that there was a problem with the supply. The January statement stressed that ``the possibility of blood born transmission [was] still unproven.''
50
In private, the banks were more forthright in their opposition. The banks later added questions about AIDS symptoms to their standard list of questions before donation. However, they were against directly questioning donors about their sexual behavior, and neither did they recommend surrogate testing. An internal American Red Cross memo circulated in February of 1983 shows how the o┬сcials in the voluntary sector were thinking at this time: 546
Page 19Relevant 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; ... (3) homosexuals and bisexuals constitute up to 25% of the donor population ... [male homosexuals] probably equal 15% or less of the donor population; ... the scienti┬уc basis for elimination of gays [from the donor pool] does not exist at present.
51
Their refusal to test for co-indicators of AIDS indicates that the banks were reluctant to take the time and money to question the quality of the gift that was being given them. External dependence on their suppliers meant that they were particularly aware of the implications of screening out homosexuals. The well-organized gay rights lobby saw the question as one of personal autonomy. They argued that the evi- dence did not warrant what would amount to outright discrimination against homosexuals. The blood banks tended to agree. The author of the same memo says ``[e]thically, I don't think sexual preference is the proper business of anyone (or any institution).''
52
This kind of concern from the blood banks was con┬уned to homosexuals, however. Groups with no representative organizations were more easily removed from the donor pool, although even this took some time. Prisoners and Haitians were excluded on the grounds that they had a high rate of hepatitis, which was the most reliable surrogate marker for AIDS at the time. Male homosexuals had a higher rate of HBV than both these groups, but were not excluded.
The blood banks began with the view that a volunteer blood donor is an altruistic person who, despite the inconvenience, takes the time to donate blood. The idea of confronting such a donor with a prying and personal question about his sexual behavior seemed reprehensible and potentially very damaging to donor movivation.... In addition, the blood banks per- ceived that the gay community might not co-operate if gay donors were rejected on the basis of sexual orientation and, furthermore, that they might donate on purpose out of spite.
53
Beyond their relationship with donors, the way the banks evaluated the available evidence was further in┬ъuenced by their relationship to other organizations in their environment. These groups had their own inter- ests, which might be to the detriment of the banks and their donors. The ARC's own analysis (in an internal memo from January 1983) of the motives of the CDC is particularly striking:
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 a major epidemic to justify its existence. This is especially true in the light of
547
Page 20Federal funding cuts.... In short, we can not depend on CDC to provide scienti┬уc, objective, unbias [sic] leadership on the topic. However, because CDC will continue to push for more action from the blood banking com- munity, the public will believe there is a scienti┬уc basis and means for elimininating gays.
54
Similarly, at a meeting of the Blood Products Advisory Committee (BPAC) in February 1983, the participants heard a summary of the cases of transfusion AIDS that the CDC had identi┬уed. This evidence was given by Dennis Donohue, the Director of the FDA's Division of Blood and Blood Products. Donohue described the case reports as ``very soft and squiggly data.''
55
When asked whether the cases were accepted as valid evidence by the CDC, Joseph Bove (the Chairperson) responded, ``Yes. Oh, my goodness, they are hanging everybody on the basis of it ... [these cases] are all, you know, very i┬нy.''
56
The banks'
assessment of risk was strongly conditioned by existing, institutional-
ized relationships with suppliers and other organizations. Their atti-
tude was that if you looked a gift horse in the mouth, not only were you
being churlish, you risked having your nose bitten as well. The blood
banks chose to play down the problem and defend their suppliers'
interests as their own. Unwilling to violate or question the gift relation-
ship that gave them their blood, they acted as if rea┬сrming their trust
in donors was the same thing as reducing the risk borne by recipients.
The plasma companies: Defending recipients
As was the case with blood, plasma recipients bore the risk of exchange
and trusted the company to minimize it. The same liability laws ap-
plied. But in this case, the risk bearers were the more valuable group
from the organization's point of view. The market for plasma was
competitive, and consumers might easily have bought a competitor's
alternative. The plasma companies also had an interest in keeping their
suppliers, of course, but this was largely solved by paying them for
their time and effort.
supply population. The memo said, ``While we recognize the potential for the rejection of long term donors, we strongly believe that the loss of these donors is more than o┬нset by the protection of our patients.''
57
This move was strongly opposed by the blood banks and the gay community. Nevertheless, the plasma companies ignored this opposi- tion.
58
They had no moral commitment to their suppliers.
After the January 1983 meeting in Atlanta, the American Blood
Resources Organization (the representative body of the plasma com-
panies) issued recommendations about donor screening and deferral
to reduce the risk of AIDS. In addition, news of AIDS in the blood
supply caused research into viral inactivation methods to be acceler-
ated. All of the U.S. plasma fractionators applied to the FDA to license
treatment methods between June 1982 and December 1983. All were
producing heat- or detergent-treated antihemophilic factor (AHF)
concentrate by February 1984.
Hepatitis was viewed as an acceptable risk for individuals with hemophilia because it was considered a medically manageable complication of a very e┬нective treatment for hemophilia.
59
In this case, the plasma fractionators fail on the same grounds as the blood banks. They had a set of known costs and bene┬уts that they used to guide the marketing and further development of their products. But they assumed that HBV was the only virus in the plasma supply and that, seeing as most of their customers had it, there was no need to develop a process to eliminate it from AHF concentrate supplies. They contrasted the large bene┬уts brought by their products to the manage- 549
Page 22able cost of hepatitis, with the emphasis strongly on the bene┬уts. When evidence about AIDS began to mount, the feeling in the industry was that, whatever it was, the costs brought by this new problem could not outweigh the bene┬уts of Factor VIII and related products. At a BPAC meeting in December of 1982, a representative of Cutter Biologics argued that ``we need to keep the life-sustaining signi┬уcance of this product to the patient, and the lack of clear-cut risk based on currently available information, foremost in our collective minds.''
60
The anticipated arrival of a HBV vaccine added to this reluctance
(the ┬уrst one became available in 1982), because uninfected people
would be protected against it in that way, rather than by some new
manufacturing process. There were no market incentives to pursue the
research. No one seemed to countenance the possibility that other
serious pathogens or latent agents (like Creutzfeld^Jakob disease or
HIV) might also be present in untreated AHF concentrate. Once
AIDS appeared, the plasma companies were able to move quickly and
in the right direction to defend their market, but by then most of the
hemophiliacs were infected anyway.
61
The plasma companies had reacted to the information by developing a new product, but doctors tended to play down the dangers. They were happy with the therapeutic e┬нects of AHF, which outweighed any other worries:
[P]hysicians tended to avoid, downplay, or deny the possible risk associated with the use of blood and blood products, one of the case studies revealed that physicians often responded to the initial questions of the patients with reassurances that the risk was not serious, that the patient was overreacting, that there are always risks, and that patients and doctors should wait and see what happens ... physicians emphasized the known bene┬уts of AHF concen- trate and underweighed the risks of AIDS, which were still uncertain.
62
The role of the plasma companies was further complicated by their relationship with the National Hemophilia Foundation (NHF). The 550
Page 23NHF ``served a crucial function as and intermediary between the sources of scienti┬уc and medical information i.e., CDC, FDA, plasma fractionation industry), and the consumers of that information.''
63
The NHF was funded in part by the plasma companies. The Institute of Medicine reports that ``the NHF's credibility ... was eventually seriously compromised by its ┬уnancial connections to the plasma frac- tionation industry.''
64
In a series of newsletters, the NHF reassured both doctors and patients that they could safely continue treatment with older batches of AHF concentrate, and other plasma derivatives that later turned out to have been infected. In July of 1982 ``Hemo- philia Newsnotes'' stressed that ``it is important to note that at this time the risk of contracting this immuno-suppressive agent [AIDS] is minimal.''
65
As with the blood banks, technically su┬сcient data to make this sort of statement about risk were not available. The NHF took a conservative line throughout 1982 and 1983. Its Medical and Scienti┬уc Advisory Council (MASAC) did eventually recommend, at a meeting in October of 1983, that blood products not be collected from homosexuals and other at-risk groups. But (like the plasma companies) they continued to use the good risk-bene┬уt data they had about Hepatitis as though it took care of uncertainty about AIDS. The NHF took the same stance as the plasma companies: the bene┬уts that plasma concentrates brought to hemophiliacs were just too large to be outweighed by information about a new disease. At worst, AIDS would probably be like Hepatitis ^ endemic, but manageable. At their October 1983 meeting, the MASAC noted with approval that data from a CDC/ NHF study showed the average life expectancy of hemophiliacs to have risen from 11 years in 1968 to 20 years in 1983. ``These ┬уndings,'' they commented, ``put into good perspective the importance of the use of [plasma] concentrates vs the small risk of AIDS.''
66
The newsletter
was still urging a conservative approach as late as January of 1984. As
a result of this reassurance, a variety of plasma products were kept on
the market for longer than they should have been, and many more
hemophiliacs contracted HIV than might otherwise have been the
case.
their recipeints were also closely interwoven, in this case with negative e┬нects. Conclusion With hindsight, there is no doubt that there was a right way and a wrong way to react to the information about AIDS that began to appear from June 1981. Decisions about donor screening, risk assess- ment and patient treatment all seem obvious. But the reactions of the blood banks and plasma companies cannot be rightly understood from this point of view. What hindsight grants us is accurate risk assessment, precisely what those involved did not have. What we can now see as risks were then simply uncertainties. To take a risk means to place a bet, and in order to place a bet you must know the odds. From the point of view of the organizations involved at the time, bets had to be placed, but the odds were not obvious. Had AIDS turned out to be a non-disaster like Swine Flu, the blood banks would have appeared prudent and the companies foolish.
67
Given this state of a┬нairs, the forces pushing on the decision-making
process are sociologically interesting. In this article I have o┬нered an
explanation for why one set of organizations rather than another
tended to do (what in retrospect turned out to be) the right thing, and
why neither was ultimately successful. I have argued that in 1982 the
blood banks and plasma companies found themselves living in an
unusually uncertain world. The result was a con┬ъict over the quality of
data, the credibility of sources, and the standards for evaluation, as
the organizations involved tried to construct a viable information
order. Unusually, in this case the standards of evidence had to be
su┬сcient not to judge the riskiness of future projects, but to establish
the existence of an ongoing disaster.
external dependencies been di┬нerent, the plasma companies might
have moved to defend the wrong group. Had their ties to other organ-
izations been di┬нerent, the blood banks might have found it easier to
get important information from their donors. Had their donors been
paid suppliers, the banks might have found it easier to eliminate some
of them from the supply pool.
were an important part of their identity. These in turn were set in the
context of both wider organizational environments and cultural ideas
about gift giving and social obligations. These factors strongly in┬ъu-
enced how organizational actors negotiated standards of proof, despite
a generally shared commitment to objectivity and scienti┬уc integrity.
The continuous danger of new uncertainties and the persistence of
these institutional arrangements makes it very unlikely that any single
aspect of organizational form or culture can reliably ensure something
like the safe and e┬сcient supply of blood.
Acknowledgments
I thank Paul DiMaggio, Paul Starr, Viviana Zelizer, Miguel Centeno,
and Laurie Paul for their comments and suggestions on earlier ver-
sions of theis article. Thanks also to anonymous Theory and Society
reviewers for a number of decisive suggestions.
Notes
1. Carol Heimer, ``Allocating Information Costs in a Negotiated Information Order:
Interorganizational Constraints on Decision Making in Norwegian Oil Insurance,''
Administrative Science Quarterly 30 (1985): 395^417.
554
Page 27
Research, 1976), 29^58; Rueben Kessel, ``Transfused Blood, Serum Hepatitis and
the Coase Theorem,'' in Johnson, Blood Policy, 183^207.
555
Page 28
from the perspective of the sociology of organizations. Shilts's book is the standard
history of the period, but his focus is not on the blood suppliers as such.
556
Page 29
37. Committee to study HIV transmission through blood products. Proceedings of a
public meeting held on September 12, 1994 in Washington D.C., U.S. Department of
Commerce, National Technical Information Service Record Locator, No. PB95^
142345.
557
Page 30
59. IOMR, 93.
558
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