HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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7 Risk Communication to Physicians and Patients
7 Risk Communication to Physicians and Patients
Pages 169-206
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From page 169... ...
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.
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From page 170... ...
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.
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From page 171... ...
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)
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From page 172... ...
The Role of the National Hemophilia Foundation In the early 1 980s, 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)
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From page 173... ...
were sent directly to treating physicians (primarily at the hemophilia treatment centers) ; chapter advisories were sent to the local chapters of the NHF.
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From page 174... ...
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 1 1, 1983, and October 5, 1984, were within days of recalls (i.e., industry's voluntary withdrawal)
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From page 175... ...
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 19821. Chapter Advisory #12 (December 21, 1983)
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From page 176... ...
176 HIV AND THE BLOOD SUPPLY Table 7.1 Summary of Clinical Options, Status and Sources of Recommendations, and Date Recommended Clinical Options Status and Sources of Recommendations Date Recommended Use of Cryoprecipitate Newborn infants and children under four; newly diagnosed and previously untreated hemophiliacs Mild hemophiliacs who require infrequent treatment For severe hemophilia A, or patients who require frequent treatment Patients under treatment with AHF concentrate should be reevaluated to see if it would be possible to switch to directed donor cryo program Discourage prophylactic treatment DDAVP (desmopress~n acetate) Should be used for mild and moderate hemophilia A whenever possible Provided as "advice" to physicians and NHF chapters by NHF AIDS Task Force Provided as recoInmendations to physicians and patients by NHF/MASAC Not recommended Minority opinion of several MASAC members; option recommended by small number of individual physicians and adopted by some hemophiliac patients and physicians December 21, 1982 January 14, 1983 Not officially recommended by NHF/MASAC Not an official recom mendation of MASAC; Not officially several treatment center physicians implement and some patients reduce their use MASAC; some physicians implement this early and encourage FDA to expedite licensing recommended by NHF/MASAC January 14, 1983 (DDAVP licensed by FDA in April 1984)
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From page 177... ...
Not recommended NHF no recommendation February 3, 1984 by MASAC 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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From page 178... ...
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.
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From page 179... ...
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.
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From page 180... ...
When plasma fractionators began to withdraw suspected lots of AHF concentrate found to be associated with a donor known to have or suspected of having AIDS (see Chapter 6) , physicians had to intensify their efforts to communicate the risks associated with blood and blood products to patients and to notify patients who may have been using, or have in their possession, contaminated lots of AHF concentrate.
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From page 181... ...
Further, blood bank leaders have often viewed discussions of the risks of the blood supply as having a detrimental effect on donation and availability (see Chapter 51. CASE STUDIES The following case studies are presented to illuminate what was communicated about the risks associated with the use of blood and blood products from the perspective of specific patients and physicians.
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From page 182... ...
were futile, as they were not receptive to the idea of such a program. He also tried to work with two universities' hemophilia treatment centers, however, both universities told him they only used donations for research projects and blood for clinical use was obtained from the Red Cross.
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From page 183... ...
In the fall of 1981, he began graduate school. He first became aware of a possible risk of AIDS from using blood products in the spring of 1982, when he read a scientific article that described an immune disorder diagnosed in a severe hemophiliac.
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From page 184... ...
. He queried his physician about the possibility that AHF concentrates were infected with the AIDS virus.
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From page 185... ...
Case Study Three: Continue AHF Concentrate Treatment This case study illuminates the influence of situational factors, or personal experience, on the perception of risk and changes in behavior. It is from the perspective of a physician of one of the larger hemophilia treatment centers where 400-500 active patients are seen at least once per year.
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From page 186... ...
Clinical care continued as usual, although a bulletin describing what was known about AIDS was issued by the treatment center to patients following the January 4, 1983, meeting. In the latter half of 1983, the treatment center held another meeting with patients and their families.
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From page 187... ...
One theory was that because that area had a high prevalence of AIDS in homosexual men, who had been donating to the blood supply, it was likely that HIV was in the donor pool and that cryoprecipitate would transmit AIDS as well. Logistically, the treatment center could not possibly have switched everyone to cryoprecipitate; but patients were given the option.
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From page 188... ...
In 1981, Mr. Thomas decided to join his local chapter of the National Hemophilia Foundation, and he became its president.
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From page 189... ...
Mr. Thomas first became aware of a possible risk of AIDS from using blood products in July 1982, when he received the first patient alert from the NHF (July 14, 19821.
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From page 190... ...
Mrs. Glaser's physicians determined that she had received contaminated blood and had unknowingly passed on the HIV infection to her daughter Ariel through breastfeeding and in utero to her son Jake.
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From page 191... ...
The case studies provide a window into the risk/benefit calculus as physicians and patients confronted the increasing risks of blood and blood products. The case studies help demonstrate how individuals pursued, or failed to pursue, various clinical options.
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From page 192... ...
in treating individuals with bleeding disorders, the confidence of hemophiliac patients and their physicians, and a reputation among government and industry leaders as representing the interests of individuals with hemophilia. While the federally funded hemophilia treatment centers disseminated information to their patients, the NHF communications provided the basis for assessment of the risk and the development of treatment options.
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From page 193... ...
Local chapters owned their own mailing lists, as did the treatment centers, and the NHF left to individual chapters and treatment centers any decision to mail or otherwise distribute information received from the NHF to members (Brownstein 1994; Bias, Carman interviews)
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From page 194... ...
Although the NHF, and MASAC in particular, may have lacked expertise in the critical areas, it did include among its membership some of the nation's most respected physicians involved with treatment of hemophiliac patients. In this respect, at least, the NHF arguably was in a unique position to give careful and informed consideration to the range of possible clinical options that patients and their physicians should consider.
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From page 195... ...
These included the tendency of physicians to not discuss, or to downplay and deny, the risk of AIDS; the confidence of physicians and patients in the benefits of AHF concentrate; the context of hepatitis as a medically acceptable risk; the difficulties of communicating dire news to patients; and the problems associated with communicating uncertainty. With reports of the Committee's finding that physicians 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 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 (see Case Study One)
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From page 196... ...
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.
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From page 197... ...
While it had entered clinical practice by the early 1920s, by the late l950s, 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., 19571.
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From page 198... ...
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.
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From page 199... ...
[Judicial Council of the American Medical Association, 19841. This review of the history of informed consent illuminates how the practice of hemophilia and transfusion medicine was somewhat removed from recognized medical norms.
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From page 200... ...
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.
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From page 201... ...
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.
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From page 202... ...
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.
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From page 203... ...
· 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.
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From page 204... ...
· 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.
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From page 205... ...
Acquired Immune Deficiency Syndrome Among Patients Attending Hemophilia Treatment Centers and Mortality Experience of Hemophiliacs in the United States.AmericanJournalofEpidemiology,Vol.
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From page 206... ...
Rosendaal, F.R., Smit, C., and Briet, E Hemophilia Treatment in Historical Perspective: A Review of Medical and Social Developments.
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