7
Risk Communication to Physicians and Patients

INTRODUCTION

The introduction of HIV into the blood supply posed powerful dangers to those individuals with hemophilia and recipients of blood transfusions during the early years of the epidemic. During the period from 1982 to 1984, before the AIDS virus was finally identified and a test developed to determine its presence, there was considerable speculation about whether the blood supply could be a vector for this new, fatal infection. As evidence about risk developed, consumers of blood and blood products—as well as their physicians—found themselves in a complex dilemma. Continued use of blood and blood products might heighten the risk of acquiring a new disease. Reducing or discouraging the use of blood products might increase the morbidity and mortality associated with hemophilia. Approximately half of the 16,000 hemophiliacs and over 12,000 recipients of blood transfusions became infected with HIV during this period (CDC, MMWR, July 23, 1993). More effective communication of the risks associated with blood and blood products and the opportunity to choose from a wide spectrum of clinical options might have averted some of these infections.

To explore these questions, the Committee analyzed how the risks associated with using blood and blood products as well as clinical options were communicated to relevant physicians and patients by examining the content and process of the communications from 1982 through 1985. The Committee focused on the information available to decisionmakers and analyzed the institutional, social, and cultural obstacles to effective risk communication. The analysis includes an examination of the information about the risks associated with blood and blood products and possible risk reduction options that were available during this period of uncertainty. The chapter also considers the role



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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 7 Risk Communication to Physicians and Patients INTRODUCTION The introduction of HIV into the blood supply posed powerful dangers to those individuals with hemophilia and recipients of blood transfusions during the early years of the epidemic. During the period from 1982 to 1984, before the AIDS virus was finally identified and a test developed to determine its presence, there was considerable speculation about whether the blood supply could be a vector for this new, fatal infection. As evidence about risk developed, consumers of blood and blood products—as well as their physicians—found themselves in a complex dilemma. Continued use of blood and blood products might heighten the risk of acquiring a new disease. Reducing or discouraging the use of blood products might increase the morbidity and mortality associated with hemophilia. Approximately half of the 16,000 hemophiliacs and over 12,000 recipients of blood transfusions became infected with HIV during this period (CDC, MMWR, July 23, 1993). More effective communication of the risks associated with blood and blood products and the opportunity to choose from a wide spectrum of clinical options might have averted some of these infections. To explore these questions, the Committee analyzed how the risks associated with using blood and blood products as well as clinical options were communicated to relevant physicians and patients by examining the content and process of the communications from 1982 through 1985. The Committee focused on the information available to decisionmakers and analyzed the institutional, social, and cultural obstacles to effective risk communication. The analysis includes an examination of the information about the risks associated with blood and blood products and possible risk reduction options that were available during this period of uncertainty. The chapter also considers the role

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking of a voluntary health organization, the National Hemophilia Foundation (NHF), in the communication of information to physicians and individuals with hemophilia. FRAMEWORK FOR ANALYSIS Critical Questions The Committee addressed four fundamental questions about the content and process of risk communication: What clinical options for risk reduction, even if marginally effective, were available and could have been communicated? What information was actually communicated to patients? What were the institutional obstacles to risk communication? What were the social and cultural obstacles that influenced physician-patient relationships and risk communication? To better understand how information about the risks associated with blood and blood products was actually perceived and responded to at the clinical level, the Committee utilized a case study approach. This approach provided the means for the Committee to gain an in-depth familiarization with the context and culture of hemophilia treatment. It also helped illuminate the range of possible clinical options that existed during this period of uncertainty, and to assess their impact in these instances. Finally, the Committee evaluated the institutional, social, and cultural obstacles to communication about the risk of using blood and blood products. Critical Factors Three critical factors in the environment for individuals who are dependent on blood products help explain risk communication patterns: (1) progress in the treatment of hemophilia; (2) the development of a national network of hemophilia treatment centers; and (3) the medical community's consideration of hepatitis as an ''acceptable risk." These factors shaped the decisionmaking process as the AIDS epidemic emerged. The advent of antihemophilic factor (AHF) concentrate in the early 1970s brought a remarkably effective means to treat a disease characterized by spontaneous bleeding, pain, crippling, and early death (Jones and Ratnoff 1991). AHF concentrates significantly altered the morbidity and mortality associated with hemophilia, dramatically improving the quality of life of those affected. In

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 1972, the major cause of death for individuals with hemophilia was cerebral hemorrhage. The mean life expectancy was approximately 40 years between 1941 and 1960 and approximately 54 years between 1961 and 1970; it increased to 60 years between 1971 and 1980 (Jones and Ratnoff 1991). By the early 1980s, hemorrhage was no longer the major cause of death (Levine interview). To the extent that the pain and the visible signs of a crippling disease were reduced, the stigma of hemophilia was also significantly reduced (Jones and Ratnoff 1991; Resnik 1994). While the development of the AHF concentrate products revolutionized the treatment of hemophilia, the development of hemophilia treatment centers provided a nationwide system of care and treatment. In 1975, the federal government established funding for 20 regional centers, representing approximately 100 local treatment centers, to provide hemophilia care (Department of Health and Human Services 1994). The treatment centers ensured comprehensive medical care and early application of treatment as well as fostering a sense of community for individuals with hemophilia and their families (Smith and Levine 1984). In the setting of the treatment center both physicians and patients were able to see the advantages of treating bleeding episodes early. This observation translated into advocating home care therapy; hemophiliac patients and their families quickly became proficient in self-infusion (Smith and Levine 1984). The results were significant—home care therapy nearly eliminated the crippling associated with the disease and led to significant improvements in the health and quality of life for the individual with hemophilia (Eyster, et al. 1980; Brinkhous 1981; Smith and Levine 1984; Rosendaal, et al. 1991; Chorba, et al. 1994). In this context of progress in the treatment and care of hemophilia, the physicians treating hemophilia and their patients shared in a rather unique and close relationship. In part, this stemmed from the somewhat insular care network for individuals with hemophilia at the hemophilia treatment centers, and in part, it developed from sharing in the significant medical progress in hemophilia treatment. Hemophiliac patients and their families generally held their physicians in high regard and trusted them implicitly (Kasper interview). The third important factor in the treatment of the hemophilia patient in the years before the AIDS epidemic was the recognition that infection with hepatitis B as well as non-A, non-B hepatitis was a frequent risk associated with use of AHF concentrates (Aronson 1979; Johnson et al. 1985; Chorba et al. 1994; Hoyer 1994; Goldfinger, Kasper, Louvrein, Roberts interviews). This observation can be traced to the early 1970s when hepatitis emerged as a frequent complication in patients receiving blood and blood products (Seeff 1988). During this era, it came to be expected that most hemophiliac patients would develop hepatitis (Chorba, et al. 1994; Hoyer interview). Although hepatitis infections were occasionally severe, leading to liver failure and death (Aronson 1979; Johnson, et al. 1985), the benefits of treatment seemed to outweigh the risks from such

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking infections (Hoyer interview). In the context of the dramatic improvements in the care and treatment of hemophilia offered by AHF concentrates, infection associated with the use of these blood products came to be deemed an "acceptable risk" (Aledort 1982; Aronson 1979; Hoyer 1994; Furie, Roberts interviews). It was against this background that the initial reports began to surface that individuals with hemophilia and transfusion recipients might be at risk for a new disease, called AIDS. There was considerable uncertainty and disagreement among medical, scientific, and public health decisionmakers about whether AIDS was a new disease, and if it could be transmitted via a blood-borne agent (Public Health Service 1982; FDA, BPAC 1983). If AIDS was a new, blood-borne disease, the implications for individuals with hemophilia—as well as other consumers of blood and blood products—could be dire. The Role of the National Hemophilia Foundation In the early 1980s, there was no organization that assumed specific responsibility for communicating directly with physicians and patients about the risks associated with blood and blood products. Although the hemophilia treatment centers received federal funding, the basis of information about the nature of the risk of AIDS associated with blood and blood products came from the National Hemophilia Foundation (NHF) and its Medical and Scientific Advisory Council (MASAC), whose membership included medical directors of hemophilia treatment centers. Immediately upon hearing directly from the CDC about three cases of AIDS in individuals with hemophilia (CDC, MMWR, July 1982), the NHF took on the responsibility of communicating to physicians and patients about the epidemic and the risks associated with use of blood products. In this role, NHF served a crucial function as an intermediary between the sources of scientific and medical information (i.e., CDC, FDA, plasma fractionation industry) and the consumers of that information—the physicians and users of blood products who had to make daily decisions about hemophilia treatment. Founded in 1948, the NHF was committed to advancing the care and treatment of persons with hemophilia and strengthening the community. During the mid-1970s, NHF helped to successfully lobby for major changes in the care and treatment of hemophilia (Aledort, McPherson interviews; Brownstein 1994). But in 1982, it stepped into a new role for which it had little preparation and experience and limited resources. First, in the early 1980s, the NHF was recovering from bankruptcy and had a small staff (Brownstein 1994; Bias, Carman interviews). In addition, it had limited funding and expertise for developing a system for communicating information until it obtained additional support from Human Resources and Services Administration's Office of Maternal

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking and Child Health (HRSA/OMCH) in October 1983 (NHF 1983). The decisions about what to communicate and the process for communication, however, remained the primary responsibility of the NHF. The leadership of NHF was comprised of individuals who were committed to the advancement of medical care and services for individuals with hemophilia. The NHF had established close relationships with the plasma fractionation industry (pharmaceutical companies) which provided badly needed financial support for some of the NHF's activities, including its communication programs (Aledort interview; Hammes pers. com. 1995; Brownstein, 1994). NHF, with the help of its newly reconstituted Medical and Scientific Advisory Council (MASAC), established itself as the primary source of information for the consumers of blood products (Brownstein 1994). Given the heated tenor of the discussions of the AIDS crisis, and the complex scientific, medical, and social questions that it would raise, the NHF's assumption of responsibility for communicating expert advice was without precedent in its history. The NHF utilized two modes of communication, medical bulletins and chapter advisories, for educating and advising physicians and patients concerning what was and was not known at the time. (Appendix C summarizes these communications.) Medical bulletins formulated by members of the NHF AIDS Task Force and some of the members from MASAC (referred to as Hemophilia Newsnotes) were sent directly to treating physicians (primarily at the hemophilia treatment centers); chapter advisories were sent to the local chapters of the NHF. From July 1982 through December 1985, the NHF issued 32 medical bulletins and 37 chapter advisories. Both forms of communication came from the leadership of the NHF rather than directly from MASAC (Aledort, Carman interviews). The information developed for the recommendations came from the interactions of the NHF AIDS Task Force with government and private organizations. The communications were written by the members of the NHF AIDS Task Force, with review and approval of MASAC members. The AIDS Task Force was an ad hoc group comprised of the MASAC chair (Dr. Leon Hoyer), the NHF officers including the executive director (Mr. Alan Brownstein), the medical director (Dr. Louis Aledort), and the president (Dr. Charles Carman). The NHF AIDS Task Force had the primary role of collecting information, interacting with the various federal and private organizations about the risks associated with blood products, and developing recommendations and advising the NHF leadership about the HIV risks. The NHF executive director and board had the final authority over the AIDS Task Force and MASAC recommendations (Aledort, Carman interviews). The process of developing recommendations and providing information also included a review by CDC scientist Bruce Evatt to ensure accuracy (Aledort, Carman, Evatt interviews).

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking The October 22, 1983, meeting of MASAC was the occasion to learn that the Office of Maternal and Child Health (OMCH), the source of federal funding for the hemophilia treatment centers, would provide practical support for the establishment of a hemophilia information exchange network. Dr. Jeanne Lusher, a member of MASAC, was designated to be the project director for the hemophilia information exchange (HIE) (NHF 1982a). OMCH worked with MASAC and the NHF to set up a process for information exchange. The NHF, however, took the primary responsibility for developing the information and disseminating it to the treatment centers and chapters (McPherson interview). The purpose of the information exchange network was to provide paid subscribers with "preprints" (manuscripts not yet published in scientific journals) concerning various aspects of hemophilia, including, orthopedic management, genetic analysis, inhibitors, and infectious complications such as AIDS. A bibliography of articles of interest to the hemophilia community was included in each distribution. Although MASAC had committed itself in October 1982 to provide the same information to patients that was provided to physicians, the primary recipients of NHF communications were the physicians and chapter leaders (NHF 1982b). Indeed, a cover letter, dated July 19, 1982, from Charles Carman to NHF chapter presidents, accompanying Chapter Advisory #2, explicitly recommended that the Advisory be kept in the chapter files to answer questions about Pneumocystis carinii pneumonia (PCP) and that mass mailings were not necessary. Although some specific messages changed over time, the recommendation to continue to use AHF concentrate for severe hemophiliacs remained constant from January 1983 to October 1984, when the NHF first recommended using heat-treated concentrates. The communication issued on July 14, 1982 (Patient Alert No. 1), was the first of many NHF communications that stressed that "the CDC was not advising a change in treatment regimen at this time." Although some specific recommendations changed over time, one message remained constant throughout the entire period: "Patients [should] maintain the use of concentrate or cryoprecipitate as prescribed by their physicians. The life and health of hemophiliacs depends on the appropriate use of blood products." The NHF reaffirmed this message in medical bulletins and chapter advisories on many occasions, six of which, between May 11, 1983, and October 5, 1984, were within days of recalls (i.e., industry's voluntary withdrawal) of AHF concentrate due to the diagnosis of AIDS in individuals donors. Many of the communications contained messages to encourage patients to maintain current treatments and to reassure them that the risk was remote despite the possibility that the patients may be using vials of AHF concentrate from lots recalled by industry's voluntary withdrawal of the product [Medical Bulletin #7, May 1983; Chapter Advisory #8, May 1983; Chapter Advisory #9, September 1983; Chapter Advisory #11, November 1983; Chapter Advisory #13, January 1984; Chapter

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Advisory #19, October 1984; Chapter Advisory #24, December 1984; Medical Bulletin #20, December 1984]. RISK REDUCTION OPTIONS Many of the debates and discussions that occurred during the MASAC and NHF meetings concerned clinical options to reduce the risk of AIDS transmission for individuals who were using blood products or were in need of receiving blood transfusion. Although these options to reduce the risk of AIDS transmission through blood products were not appropriate to every patient's circumstances, there was a range of clinical approaches for physicians and their patients to consider. The full list of these options is shown in Table 7.1. The Committee found that, for the most part, there was little systematic communication and assessment of the full range of these options for reducing the risk of infection. Specific Options The primary clinical option for mild, moderate, and previously untreated hemophiliacs was to use cryoprecipitate rather than AHF concentrate. Because cryoprecipitate is derived from single donors or small pools of 10–15 donors, some physicians believed that it was less likely to be infected with AIDS (Roberts interview; Ratnoff 1994). There were several rationales for not recommending cryoprecipitate, including issues of adequate supply, requirements for storage, and unfavorable attitudes (Aledort, Dietrich, Kasper, Levine, Lusher interviews). In addition, blood bank officials were concerned about the burden of extra work for the blood banks (Barker, Sandler interviews). A minority of MASAC members advocated cryoprecipitate for treating mild, moderate, and severe hemophilia, but it was never an official recommendation of MASAC or the NHF. The Committee is not aware of any systematic studies of cryoprecipitate, and it seems that this option was discarded as infeasible without a thorough analysis. The NHF communications reflected inconsistency, or at least some degree of ambivalence, in the presentation of information about this option. Communications as early as December 21, 1982, and again on January 14, 1983, cautioned against introduction of AHF concentrates to individuals who had never used them before and recommended the use of cryoprecipitate instead [Chapter Advisory #5 and Medical Bulletin #4, December 1982]. Chapter Advisory #12 (December 21, 1983) said that the potential advantages of cryoprecipitate over AHF concentrates were unknown. Most of the adult hemophiliacs had used cryoprecipitate or fresh frozen plasma to treat their

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Table 7.1 Summary of Clinical Options, Status and Sources of Recommendations, and Recommended Clinical Options and Date Recommended Status and Sources of Recommendations Date Recommended Use of Cryoprecipitate Newborn infants and children under four; newly diagnosed and previously untreated hemophiliacs Provided as "advice" to physicians and NHF chapters by NHF AIDS Task Force December 21, 1982 Mild hemophiliacs who require infrequent treatment Provided as recommendations to physicians and patients by NHF/MASAC January 14, 1983 For severe hemophilia A, or patients who require frequent treatment Not recommended   Patients under treatment with AHF concentrate should be reevaluated to see if it would be possible to switch to directed donor cryo program Minority opinion of several MASAC members; option recommended by small number of individual physicians and adopted by some hemophiliac patients and physicians Not officially recommended by NHF/MASAC Discourage prophylactic treatment Not an official recommendation of MASAC; several treatment center physicians implement and some patients reduce their use Not officially recommended by NHF/MASAC DDAVP (desmopressin acetate) Should be used for mild and moderate hemophilia A whenever possible MASAC; some physicians implement this early and encourage FDA to expedite licensing January 14, 1983 (DDAVP licensed by FDA in April 1984)

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Clinical Options Status and Sources of Recommendations Date Recommended Surgical Procedures Elective surgical procedures should be evaluated for possible delay MASAC January 14, 1983 Physicians should strictly adhere to medical implications for transfusions, and autologous blood transfusions are encouraged PHS March 4, 1983 Heat-Treated Products Expedite the development of processing methods to inactivate viruses potentially present in AHF concentrate MASAC December 2, 1983 Physicians should strongly consider changing to heat-treated AHF concentrate MASAC October 13, 1984 (FDA licensed first heat-treated product March 1983; all four companies licensed by October 1984) Secondary Transmission Warnings     Use condoms or practice safe sex Not recommended   Open discussion between sexual partners and advice from physicians NHF no recommendation by MASAC February 3, 1984 disease before AHF concentrate became the standard treatment in the mid- to late 1970s. It is more difficult to treat adults who have severe hemophilia with the cryoprecipitate or fresh frozen plasma because of the large amount that is

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking required. To go back to cryoprecipitate or fresh frozen plasma presented several obstacles in terms of logistics, amount needed, and the time involved in this type of infusion. That the NHF and MASAC did not recommend some clinical options to prevent AIDS in hemophiliac patients did not discourage some patients and their physicians from improvising. The Committee found several instances of physicians implementing risk-reduction strategies such as discouraging prophylactic treatment and reevaluating the frequency of using AHF concentrate. Physicians who implemented these options instructed their patients about what types of bleeds to treat, when, and how often. Personal circumstances and fears about not treating serious bleeds made some physicians apprehensive about instructing patients to not treat bleeding episodes (Aledort, Dietrich, Levine interviews). The NHF recommended the use of DDAVP (desmopressin acetate) to treat mild and moderate cases of hemophilia A, an option implemented by several physicians, initially for mild cases and later for moderate individuals (Dietrich, Kasper interviews). The availability of this experimental product came at the urging of the medical community, both to plasma fractionators for development and to FDA expeditious licensing of the product, which occurred by April 1984 [Medical Bulletin #5, January 1983; Chapter Advisory #15, April 1984]. In many cases, physicians treating individuals with hemophilia decided to delay elective surgical procedures on their patients (Dietrich, Kasper interviews), only to abandon this strategy after none of their patients developed symptoms of AIDS and individual patients insisted upon having the corrective surgery without delay (Dietrich interview; see also Case Study Two below). Neither the NHF and MASAC nor individual physicians appear to have devoted much effort to communicating the possibility of the risk of secondary transmission of HIV to their sexually active, and possibly HIV-infected, hemophilia patients. The NHF did not communicate information about the risk of secondary transmission until it issued Chapter Advisory #14 on February 3, 1984. The communication discussed the risk of secondary transmission through sexual activity or other forms of intimate contact, but characterized the risk as remote. The NHF bulletin encouraged open communication between patients and physicians (NHF 1984). The MASAC never issued official recommendations about sexual transmission of AIDS. The February 4, 1984, NHF medical bulletin communication about secondary transmission of AIDS provided information on the death of a 70-year-old hemophiliac who had died from AIDS in May 1983. The NHF communication stated that the wife was not known to be a member of a high-risk group, but it was still possible that she developed AIDS first and spread it to her husband, and that the patient's vulnerability may have been a function of age, rather than sexual contact. The communication stated there was still controversy about whether secondary transmission of AIDS could occur but that

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking all agreed that if sexual partners of hemophiliacs were at increased risk of contracting AIDS, the risk was small: "Individual patients and their treaters need to consider whether or not they wish to employ prophylactic methods (e.g., condoms) in continuing their sexual relations as a strictly precautionary and temporary measure until more is learned about AIDS." The Committee learned that some physicians were frightened by the possibility of secondary transmission of AIDS (Hoyer interview). MASAC acknowledged its limitations in dealing with AIDS transmission. According to Brownstein (1994), MASAC members were hematologists and did not have expertise in the area of sexual disease transmission. The NHF transmitted information about sexual transmission of AIDS from the CDC to treating physicians as they were informed. The NHF did not always fully communicate information. The NHF and MASAC did not communicate information about the availability of heat-treated products until October 1984, when it recommended using them after all four companies had received FDA license approval for their heat-treated products. The rationale for not prescribing heat-treated products included the absence of clinical trials to prove their effectiveness for viral inactivation, a belief that use of these products could lead to the development of inhibitors, their higher costs to the patient, and that these products were developed for eliminating hepatitis and therefore not necessary for those who were known to be infected with hepatitis (Aledort, Dietrich, Lusher interviews) (see Chapters 4 and 6). The NHF communications did not include information to help patients better understand product treatment methods, such as heat treatment, and other possible risk-reduction options. The Process for Developing NHF Guidelines After reviewing specific clinical options, the Committee examined the process by which the NHF developed its recommendations. While information about potential consequences for large-scale infection within the hemophilia community alerted members of the NHF to recommend several alternative treatment options, the NHF did not provide full information about potential risk reduction options. The NHF also did not say that there were debates within MASAC regarding some of the potential treatment options (Carman, Roberts interviews). Although the evidence that AIDS could be blood-borne was not conclusive in the earliest stages of the epidemic, the sense of urgency with which meetings were called and conducted, the early discussions of the potential needs for increased production of cryoprecipitate, and the explicit consideration of other possible changes in the treatment and management of hemophilia provide evidence that the NHF leadership was aware of a range of clinical

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking hemophilia (see Case Study One; Bias, Dietrich interviews). In addition, physicians downplayed the size of the risk, saying, for example, "that the patient need to be concerned because only one percent of hemophiliacs were contracting the disease" (see Case Study Two). Information from the NHF and the treatment centers repeated these messages. For example, in a February 1983 newsletter one hemophilia treatment center [Regional Comprehensive Hemophilia Center of Central and Northern Illinois] told patients that "out of some 20,000 hemophiliacs in the U.S., about 10,000 with severe hemophilia A, who have been transfusing some 500 million units of factor VIII each year, only eight or ten have developed AIDS." Similar estimates appeared in information sent to individuals with hemophilia by the plasma fractionation industry. In assessing the risks associated with using blood and blood products, physicians emphasized the known benefits of AHF concentrate and underweighted the risks of AIDS, which were still uncertain. The NHF and MASAC assessment weighed the benefits of AHF concentrates against what it perceived as "small numbers of AIDS cases in hemophiliacs," and recommended a firm policy to adhere to AHF concentrate therapy rather than cryoprecipitate. Some physicians believed that any change in treatment would endanger the lives of their patients and that the good quality of life with AHF concentrate outweighed the uncertainties of AIDS risk and prognosis (Aledort, Dietrich interviews). In their risk-benefit analysis, physicians believed that the probability of getting AIDS was lower than the probability of morbidity from nontreatment (Aledort interview). Whereas many in the hemophilia treatment community knew the morbidity and mortality attributable to decreased use of AHF concentrate, the morbidity and mortality from AIDS was unknown (Aledort, Carman, Dietrich, Kasper, Levine, Lusher interviews). Individuals with hemophilia had similar perspectives (Bias, Wadleigh, Dubin, Botelho interviews). According to Bias, "One theory was that hemophiliacs would develop antibodies, like hepatitis, and would not be infected. This was coupled with the desire to lead a normal life" (Bias interview). In one case study (Case Study Four), the father of two sons with hemophilia believed that if he stopped using the AHF concentrate treatment prescribed by his son's physician, the boy would bleed to death. Some of the attitudes of the patients and their physicians originated in the 1970s when hepatitis emerged as an infectious complication in patients receiving blood and blood products (see Chapter 4). In the context of hemophilia treatment, hepatitis became a medically acceptable risk. In the beginning, HIV engendered analogous attitudes (Lusher interview). Although hepatitis infections were occasionally severe, leading to liver failure and death, it was clear to many physicians that the benefits of the AHF concentrate treatment or the blood transfusion outweighed the disability from the hepatitis (Aledort, Alter, Goldfinger, Hoyer, Johnson, Levine, Lusher interviews). Hepatitis was seen as well understood and manageable: "We used to deal with hepatitis, you get it

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking from blood, it was well established. No one got sick right away … and it was not life-threatening" (Alter interview). Individuals with hemophilia knew that hepatitis was a problem associated with using AHF concentrate derived from pooled plasma from thousands of individuals (see Case Study Four; Aledort interview). Hepatitis was "acceptable," and individuals with hemophilia were told not to be concerned about it (case study four; Bias interview). When AIDS appeared in the early 1980s, the first reaction of both physicians and individuals was that this new problem would also be manageable (Case Study Three; Bias, Botelho, Louvrein interviews; Pierce 1983). "The response of the patients was not one of fear, and the parents of hemophiliacs were getting used to the risks involved with hemophilia" (Louvrein interview). As late as the end of 1984, the number of hemophiliacs with AIDS was small compared to the number of patients who received AHF concentrate, and some MASAC members doubted that the infection would become widespread among hemophiliacs (Aledort, Carman, Lusher interviews). Their judgment was due to the then widespread misunderstanding of the length of the latency period in HIV infection and thus what was assessed as the small number of patients with AIDS relative to the number with HIV infection. As the recognition of the risks of infection with AIDS grew during the period between early 1983 and mid-1984, physicians and other providers of hemophilia care began to assume that most of their patients might already be infected. This assumption also contributed to the rationale to maintain treatment regimens with AHF concentrate. If patients were already infected, changing to cryoprecipitate would only lead to suboptimal treatment for the symptoms of hemophilia; it would no longer reduce the risk of infection. Therefore, many physicians decided not to change their approaches to treatment. The Committee believes that these explanations do not provide sufficient justification for the NHF's decision to communicate only its conclusions rather than provide patients and physicians with the information needed for them to reach their own conclusions. The doctrine of informed consent—communication of information and discussion of treatment alternatives and risks by physicians to their patients—has long been recognized as a central moral and legal tenet of medical practice in the United States (Katz 1986; Faden and Beauchamp 1985). While it had entered clinical practice by the early 1920s, by the late 1950s, the legal duty to obtain consent had evolved to include an explicit duty of physicians to disclose to patients medical information relevant to making a decision about treatment [Salgo et al. v Leland Stanford, Jr., 1957]. However, in some special medical practices, such as hemophilia and transfusion medicine, it was not fully adhered to until the early 1980s. However, court opinions during this era qualified the duty of disclosure by permitting physicians to exercise discretion when full disclosure was deemed medically inappropriate. As Jay Katz has observed, both law and society more generally reflected a fundamental ambivalence between a

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking commitment to patient self-determination and traditional practices of medical paternalism (Katz 1986). By the early 1970s, however, the ambivalence was replaced by a more stringent conception of the duty of physicians to disclose all relevant information to patients. In Canterbury v. Spence, the first and most influential of a series of court cases in the 1970s, the court held: "[T]he patient's right of self-determination shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice" [464 F. 2d 772, 786 (D.C. Cir 1972)]. Faden and Beauchamp, in their authoritative treatise A History and Theory of Informed Consent, summarize the impact of Canterbury and other cases from this period as follows: "[These cases] recognized that although professional expertise is necessary in identifying the nature and consequences of the procedure, the feasibility of alternatives, and the severity of risks, once the physician has exercised medical judgment in developing and presenting this information to the patient, further deference to the physician's judgment is unnecessarily in derogation of the patient's decisionmaking right" (Faden and Beauchamp 1985). An influential 1980 California Supreme Court case, Truman v. Thomas, represented the logical culmination of the changes in judicial attitude about matters requiring disclosure. The Truman decision made it clear that a physician's duty of disclosure encompasses discussions of all relevant treatment options, including the option of nontreatment and its attendant risks and benefits [165 Cal. Rpter, 308, 611 P 2d902 (Cal. 1980)]. The decade of the 1970s thus closed with a legacy of litigation that fundamentally changed the common law of informed consent in most states, and in half of the states newly enacted legislation replaced the remnants of the common law with explicit requirements for adequate disclosures (President's Commission for the Study of Ethical Problems in Medicine and Behavioral Research, 1983). These changes in the law reflected an emerging social consensus on the importance of full disclosure of information to patients for the exercise of the patient's right of self-determination. This new consensus also rested on grounds other than the rationale embodied in the law. Medical ethicists such as Robert Veatch (1982) of the Hastings Institute argued that informing patients of treatment alternatives so that they can participate in or control the decisionmaking process increases the likelihood that benefits to individual patients will be maximized and other social objectives such as improved medical decisionmaking would be achieved [DHEW Publication No. 78-0014, 1982]. Indeed, a substantial body of empirical literature demonstrates that enhanced communication and discussion of treatment alternatives and risks improves patient satisfaction, understanding and deliberation, adherence to treatment, and medical outcomes (Levine, et al. 1979; Eraker, et al. 1988; Hall, et al. 1988).

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking The norms of full disclosure of the benefits and risks of alternative treatment options had become deeply entrenched in clinical practice by the early 1980s. The best evidence of how pervasive these norms had become can be found in a 1981 statement of the Judicial Council of the American Medical Association: The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted: (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when the risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physicians may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment [emphasis added] [Judicial Council of the American Medical Association, 1984]. This review of the history of informed consent illuminates how the practice of hemophilia and transfusion medicine was somewhat removed from recognized medical norms. The Committee also found that some physicians were reluctant to discuss bad news, including a prognosis with dire implications, once symptoms of AIDS began to occur in their patients. Even when confronted with initial symptoms of AIDS, the physician's message to his patient sometimes was to not worry (see Case Study Four). The appearance of AIDS in a previously healthy individual with hemophilia became a frightening experience for physicians (Hoyer interview). Once physicians realized that the majority of individuals with severe hemophilia were infected with HIV, they became uncomfortable with discussing the implications of the widespread infection with their patients (Dietrich, Dubin, Levine, Kasper, Lusher, Wadleigh interviews). In addition, medical uncertainty about the incidence of the infection caused difficulties in communications between physicians and their patients (Aledort, Carman, Crispen, Dietrich, Kasper, Louvrein, Lusher, Silvergleid interviews). According to one physician, "somehow there were enough different things being conveyed, different theories, and a lot of opposition to the idea that all of the clotting factor was contaminated. And, [there was] a lot of unknown[s] about whether or not we did have any alternative; whether or not heat treatment would kill the virus or whatever was causing AIDS, so that really nothing was done" (Lusher interview). Under the uncertainty posed by the risk of blood-borne transmission of AIDS, many physicians attempted to communicate risks to their patients using

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking strategies to present information gently [The Hemophilia Bulletin, Orthopedic Hospital, January 1983; Regional Comprehensive Hemophilia Center of Central and Northern Illinois, February 1983] as if to counter the effect of information that patients had heard from more alarmist sources, such as the public media (Levine interview). The public media played an important role in raising the consciousness of hemophilia patients about their risk of AIDS. Physicians became concerned because many of the patients were reducing their use of AHF concentrate (Dietrich, Levine interviews). In some instances, physicians believed that one of the reasons patients were reducing their use was because of the public media: ''You couldn't open a newspaper or magazine without seeing an AIDS patient along with language linking it to hemophilia. So we went through late 1983 and early 1984 seeing many patients withholding treatment. You had people come in with horrible lesions that you had gotten used to not seeing anymore" (Levine interview). Counteracting media attention was one reason for the NHF policy of urging treatment physicians to reassure patients that the risk of AIDS was low and to maintain their use of AHF treatment (Carman interview). In the early days of AIDS in hemophilia patients, there were many examples of ill effects of reducing use of AHF concentrate and few patients with symptoms and signs of AIDS. By the end of 1983, one of the largest hemophilia treatment hospitals had not yet seen a case of AIDS in their patients but they did have a young child die from intracranial bleeding because the person was afraid of the treatment (Dietrich interview). The death of the young hemophiliac from an intracranial bleed reinforced physicians' fears and beliefs of how important it was to maintain treatment. Soon, AIDS would appear in hemophilia patients, and there would be second thoughts about the balance of risk and benefit from AHF concentrate treatment. The uncertainty of the AIDS epidemic bred difficulty in communication between physicians and their patients. In response to the medical uncertainty, physicians had difficulty deciding to change, especially when the experience of both the physicians and patients was based on the success of AHF concentrate (Aledort, Dietrich, Levine, Lusher interviews). For example, several physicians reported that patients and families resisted MASAC's cryoprecipitate option if they had experience with AHF concentrate. But some individuals with hemophilia believed that single donor cryoprecipitate was a way to buy time (see Case Study Two). In several instances, physicians or patients who contacted the American Red Cross to obtain cryoprecipitate were told that it was not available (see Case Study Two; Dietrich, Louvrein interviews). But even when cryoprecipitate was available, patients were resistant to using it (Dietrich, Lusher interviews). Patients and their families seemed unwilling to "go back" to the previous era of dependence on cryoprecipitate (Aledort, Dietrich, Kasper, Levine, Lusher interviews). Patients and physicians both seemed to want to

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking maintain the status quo, perhaps believing that in the face of uncertainty, the best option was inaction. CONCLUSIONS In its analysis of risk communication, the Committee sought to identify the clinical options that would have reduced the risk of AIDS and to understand what information was actually communicated to patients. In those instances in which information seems not to have been communicated, the Committee explored the institutional, social, and cultural obstacles to communication. The Committee drew the following conclusions: Individuals who were dependent on blood and blood products during the AIDS epidemic faced difficult decisions and desperately needed information. Physicians and patients who had become accustomed to making few decisions suddenly found themselves in complex clinical situations in which the risks and benefits of treatment were now uncertain. Restricting or abandoning the use of blood and blood products could lead to increased mortality and morbidity. On the other hand, continued use of these products apparently increased the risk of AIDS. The NHF stepped into a critical communication role. As often happens in times of intense scientific and medical uncertainty, communication to individuals with hemophilia and to transfusion recipients about the use of blood and blood products was limited in the early years of the epidemic. The NHF acted during these years as an intermediary between federal agencies and the hemophilia community. There was no single government agency responsible for providing information about the risks associated with blood products directly to the consumers of those services. The NHF was able to do this because it was the only national organization with the expertise (through MASAC) in treating individuals with bleeding disorders. In contrast to the situation for hemophiliacs, no organization stepped forward to communicate the risks of blood transfusions to potential recipients. Many blood bank officials during this period publicly denied that there were any significant risks of AIDS to blood recipients. In this context, because many transfusions occurred on an emergency basis, patients were often not apprised of the growing concerns about the contamination of the blood supply. For both individuals with hemophilia and transfusion recipients, concern that they might refuse care deemed a "medical necessity" further contributed to failures to apprise them fully of the risks.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking There were many clinical options for responding to the potential risk, but patients did not actively consider many of them. The Committee documented that a range of clinical options might, in some instances, have reduced or eliminated dependence on AHF concentrate, thereby reducing the risks of HIV infection in the early years of the AIDS epidemic. While it listed some of these options, the NHF never encouraged thorough discussion of these options by patients with severe hemophilia. Rather, the NHF advocated continued use of AHF concentrates for these patients. While members of MASAC were concerned that alternative treatments were unproven, nonetheless, discussion of full range of options with patients should have occurred. The dramatic successes in the 1970s of treatment with AHF concentrate provided a context in which it was very difficult to abandon, or radically restrict, use of these products for severe hemophiliacs. In their effort to find the right balance between the risks and benefits of AHF concentrate, the NHF, MASAC, and physicians tended to overweight the known risks (i.e., bleeding due to inadequate treatment) and underweight the risks that were still uncertain (i.e., infection with a new, unidentified infectious agent). Given that so few hemophiliacs had actually manifested symptoms of AIDS, and with no intuition that AIDS has a long asymptomatic incubation period, many concluded that it would be inappropriate to "overreact" to reports of possible blood-borne transmission of the disease. Concerns that patients would respond irrationally to reports of the epidemic led to attempts to "reassure" the hemophiliac community about the use of blood products. The NHF had serious institutional shortcomings as it tried to assume its self-designated role as the source of information about AIDS and its treatment options. These included inadequate resources and experience; possible conflicts of interest problems; and a generally paternalistic communication style that did not accommodate itself to the uncertainties and complexities attendant upon the emergence of AIDS. Institutional barriers to patient-physician communications and complex relationships between relevant organizations impeded the flow of information. If the NHF had received input from a wider group of experts and consumers, it might have communicated a more explicit and systematic list of clinical options. In addition, in the Committee's opinion, financial and other relationships between the NHF and the blood products industry presented a conflict of interest that ultimately compromised the perceived independence and credibility of NHF's recommendations. The NHF undertook a mission that now clearly corresponds to the task of advising patients and physicians about the benefits and risks associated with

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking alternative treatment options. The NHF mission was to give treatment advice, but the advice was conclusory. It was offered without discussion of the range of options, the benefits and risks associated with each option, the medical or scientific rationales for its conclusions, or the areas in which uncertainty or scientific disagreement existed. Given the level of uncertainty engendered by the early years of the epidemic, the NHF should have more fully appraised its constituents of the process and logic of its recommendations, and should have done more at an earlier date to publish information patients and physicians might have used in only their assessments and decisions. There were serious social and cultural obstacles to communicating clinical options to reduce the risk of HIV infection for users of blood and blood products. These include the inability of some physicians to accept the implications and their preference for the status quo; misplaced confidence in AHF concentrate; a context in which some severe risks were medically acceptable; and the difficulty of talking about a dire prognosis and communicating uncertainty. Physicians tended to not discuss all clinical options since their relative merits were so difficult to evaluate in the context of the powerful uncertainties of the AIDS epidemic. During this period, the knowledge base of AIDS was changing rapidly. Buffeted by news and rumor, with no consistent sources of information, many physicians opted to maintain the status quo in their treatment recommendations. In the Committee's view, once the NHF and physicians embarked on a course in which disclosure was constrained, it became much more difficult to move toward disclosure of risk. As physicians began to recognize that many hemophiliacs were infected, the difficulty of discussing the dire implications of the epidemic also compromised candid discussion between patients and physicians. In addition, the Committee found that the NHF did not perceive the need to let the patients themselves decide matters that were far too complex for simple recommendations. The prevailing assumptions in the hemophilia community about the medically acceptable risks of hepatitis virus infection led to complacency and failure to react to reports of a new infectious risk with sufficient concern. Paternalistic assumptions about medical decisionmaking led to failures to adequately disclose the risks of continuing to use AHF concentrate and enable individuals to make informed decisions for themselves. Failures to develop opportunities for communicating the possibility of widespread infection in the hemophiliac community led to ancillary failures to warn possibly infected individuals of the risks they might pose to others through sexual contact. These obstacles resulted in poor communication of information.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking The Committee believes that the need for communication of information actually increased as the dimensions of the epidemic became more apparent. Medical uncertainty increases the need for communication of information about risks associated with blood and blood products and risk reduction options. Better recognition of obstacles to communication of options and a deeper commitment to present patients with a range of possible clinical options might have reduced the powerful sense of betrayal and guilt experienced by many hemophilia patients and their families. In instances of great uncertainty, it becomes more important for patients to become active participants in the evaluation of the risks and benefits of alternative treatments. Active participation requires knowledge of options. The failure to adequately and fully communicate these options led to a powerful sense of betrayal that exacerbated the tragedy of the epidemic for many patients and their families. The Committee concluded that there were serious shortcomings in effective communication of risks associated with the use of blood and blood products. Uncertain circumstances warrant increased communication of information about risks associated with blood and blood products and risk-reduction options. As often happens in times of intense scientific and medical uncertainty, communication about risks, benefits, and clinical options was limited. REFERENCES Aledort, Louis. Current Concepts in Diagnosis and Management of Hemophilia. Hospital Practice; October, 1982. Aronson, David. Factor VIII (Antihemophilic Globulin). Seminars in Thrombosis and Hemostasis, Vol. VI, No. 1; 1979. Brinkhous, Kenneth. "Hemophilia and Hemostasis: An Overview." In Progress in Clinical and Biological Research, Vol. 72: Hemophilia and Hemostasis, Menache, et al. editors, New York: Alan R. Liss, Inc., 1981. Brownstein, Alan. U.S. District Court Northern District of Illinois, Eastern Division, Wadleigh, et al. vs Rhone Poulenc-Rorer, et al. Case No. 93C 5969; June 20, 1994. Brownstein, Alan. Presentation to the World Federation of Hemophilia; June 28, 1983. Carman, Charles and Aledort, Louis. The National Hemophilia Foundation. Letter to Cutter Laboratories, Inc., November 2, 1982. Centers for Disease Control, Morbidity and Mortality Weekly Report , July 16, 1982. Centers for Disease Control, Morbidity and Mortality Weekly Report , March 4, 1983.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Centers for Disease Control, Morbidity and Mortality Weekly Report , July 23, 1993. Centers for Disease Control, Morbidity and Mortality Weekly Report , January 1984. Chorba, et al. Changes in Longevity and Causes of Death among Persons with Hemophilia A. American Journal of Hematology, Vol. 45; 1994. Department of Health and Human Services Public Health Service, Maternal and Child Health Bureau Fact Sheet; January 1994. Eraker, S. et al. "Understanding and Improving Patient Compliance," Annals of Internal Medicine, Vol. 100; 1988. Evatt, Bruce. Personal communication to the IOM, 1995. Eyster et al. The Pennsylvania Hemophilia Program 1973 to 1978. American Journal of Hematology, Vol. 9; 1980. Faden, Ruth R., Beauchamp, Tom L., A History and Theory of Informed Consent, (New York: Oxford University Press; 1985. Food and Drug Administration, Blood Products Advisory Committee Meeting; February 7, 1983. Glaser, Elizabeth and Palmer, L. In the Absence of Angels: A Hollywood Family's Courageous Story. G.P. Putnam's Sons, New York, New York; 1991. Hall, J., et al. "Meta-analysis of Correlates of Provider Behavior in Medical Encounters," Medical Care, vol. 26; 1988. Hammes, William J., Associate Counsel, Miles, Inc. Letter to Institute of Medicine. February 13, 1995. Hoyer, Leon. Medical Progress: Hemophilia A. New England Journal of Medicine; January 6, 1994. Johnson, et al. Acquired Immune Deficiency Syndrome Among Patients Attending Hemophilia Treatment Centers and Mortality Experience of Hemophiliacs in the United States. American Journal of Epidemiology , Vol. 121; 1985. Jones, Paul and Ratnoff, Oscar. The Changing Prognosis of Classic Hemophilia (Factor VIII deficient). Annals of Internal Medicine, Vol. 114; 1991. Judicial Council of the American Medical Association, Current Opinions of the Judicial Council of the American Medical Association (Chicago, IL: American Medical Association, 1984), 29–30 (the opinion quoted was first published in 1981). Katz, Jay, "Informed consent: a fairy tale? Law's Vision," University of Pittsburgh Law Review 39 (1977); 1986. Levine, D. et al., "Health Education for Hypertensive Patients," Journal of the American Medical Association, vol. 241; 1979. McCormick, Patricia. Living with AIDS. Parents' Magazine, vol. 68; November 1993. National Hemophilia Foundation. Hemophilia Information Exchange: AIDS Update; February 3, 1984. National Hemophilia Foundation. Medical and Scientific Advisory Council Minutes; January 14, 1982a. National Hemophilia Foundation. Medical and Scientific Advisory Council Minutes; October 2, 1982b. National Hemophilia Foundation. Medical and Scientific Advisory Council Minutes; October 22, 1983. Public Health Service. Summary Minutes "Opportunistic Infections in Hemophiliacs." July 27, 1982.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Ratnoff, Oscar. Testimony Provided to Committee. September 12, 1994. Resnik, Susan. The Social History of Hemophilia in the United States (1948–1988): The emergence and empowerment of a community. Columbia University, School of Public Health; 1994. Rosendaal, F.R., Smit, C., and Briet, E. Hemophilia Treatment in Historical Perspective: A Review of Medical and Social Developments. Annals of Hematology, Vol. 62; 1991. Seeff, Leonard. Transfusion Associated Hepatitis: Past and Present. Transfusion Medicine Reviews; December 1988. Smith, Peter and Levine, Peter. The Benefits of Comprehensive Care of Hemophilia: A Five Year Study of Outcomes. American Journal of Public Health, Vol. 74; June 1984. Veatch, Robert, "Three Theories of Informed Consent: Philosophical Foundations and Policy Implications," The Belmont Report (DHEW Publication No. 78–0014, 1982).