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7 An Approach to the Problems of Communication, Coordination, and Collaboration in Vaccine Policy Vaccine development and immunization efforts are dependent on an intricate public-private partnership in which many different "players" have traditional roles and responsibilities (Chapter 2~. These players include government funding agencies and researchers, uni- versity personnel, pharmaceutical firms, health professionals, and the public. Each responds to a wide variety of factors affecting the nature and extent of its involvement, and decisions are made on many different levels. The system is highly interactive, but it lacks any formal means to coordinate the establishment and attainment of public health goals. Few parts of the system communicate regularly and discussions involving a majority of the participants are very rare. Because no structure exists to promote such collaboration, participants may have an incomplete understanding of how their actions fit into the overall effort. The committee identified numerous problems that result from this situation and believes there is an urgent need for an organi- zation to develop and promote an effective and socially responsible national vaccine policy. HISTORICAL BACKGROUND The history of previous ad hoc groups convened to address problems related to vaccine availability and use has been discouraging and emphasizes the need for a continuing national body to monitor develop- ments in these areas. In November 1976, the Office of the Assistant Secretary for Health convened a National Immunization Conference, which was followed by workshops on specific policy issues. It was expected that the output of the conference and the work groups' recommendations would be used by the Office of the Assistant Secretary to develop an integrated national immunization policy for "departmental guidance and trans- mittal to Congress.n1 The principal recommendation arising from the endeavor was to establish a National Immunization Commission, but the report also contained comprehensive analyses of and recommendations on virtually all areas of vaccine development and use. The recommenda- tions from this exercise were not implemented, probably because of 123

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124 personnel changes in key positions within the then Department of Health, Education and Welfare. Three years later, the congressional Office of Technology Assess- ment (OTA) produced a study of federal vaccine and immunization policies relating to (1) vaccine research, development, and produc- tion, (2) vaccine safety and efficacy, (3) cost-effectiveness of vaccination and implications for reimbursement, and (4) liability and compensation for vaccine-related injuries. Policy options were identified in each of these areas.2 For the major issues discussed in the current report--ensuring sufficient levels of vaccine research, development, and production--the options were: 1. Establish a permanent interagency body within the Department of Health, Education and Welfare to · develop priorities for facilitating and coordinating vaccine research, development, and evaluation in the public sector; · monitor vaccine research, development, and production in the private sector; and · report to Congress periodically e 2. Establish either a small- or a large-scale federal vaccine production program. 3. Subsidize vaccine production by private industry. In regard to the first option, the OTA report noted: Such a body could be composed of representatives from the Government establishments primarily responsible for vaccine research, development, evaluation, purchase, distribution, and promotion. Consumers and representatives from the vaccine research communities in academe and the pharmaceutical industry also could be included. If given adequate resources and authority, an interagency body could help to establish comprehensive and unified Government policies regarding the allocation of public funds for vaccine research, development, evaluation, and use. Otherwise, it might merely add an unnecessary layer of bureaucracy.2 No action was taken on the second or third options, but an Inter- agency Group to Monitor Vaccine Development, Production, and Usage was formed in 1980 within the Public Health Service.3 The organization, composition, and purview of this body, are considerably more restric- ted than those outlined in the OTA study. All of the interagency group recommendations must be reviewed and approved by the Assistant Secretary of Health and/or the Secretary of the Department of Health and Human Services. Because participation is limited to the executive agencies of the federal government (and does not include industry, private health practitioners, or the public), the interagency group may not have the scope necessary to deal with some of the major issues affecting vaccine supply and use (e.g., liability).

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125 Two other actions resulted from the OTA study. First, reimburse- ment for pneumococcal vaccine was authorized under Medicare.4 (This remains the only preventive vaccine for general use that is reimbursed by federal medical systems [tetanus toxoid is reimbursed for use in wound management].) Second, early in 1980, the Interstate and Foreign Commerce Committee of the House of Representatives asked OTA to deline- ate the specific elements and principles necessary for inclusion in a legislative proposal to implement a compensation system for vaccine- related injury. The OTA technical memorandum Compensation for Vaccine- Related Injuries was completed in November 1980. To date, no action l has been taken to resolve problems in this area. In general, the specific actions envisaged by previous ad hoc groups have not been implemented, for reasons unrelated to their potential utility. When these groups dissolved, attention focused on their activities waned. Unfortunately, the problems with which they dealt remained and, in some areas, worsened. THE EXI STING STRUCTURE The effort to make vaccine innovation activities more responsive to public health needs depends on an understanding of problems inherent in the existing structure. Federal Agency Interactions The traditional roles and responsibilities of the National Institute of Allergy and Infectious Diseases (NIAID), the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the Department of the Army are described in Chapter 2. Despite the existence of the Interagency Group to Monitor Vaccine Development, Production, and Usage, these agencies still act largely independently, without the benefit of an overall policy framework or set of objectives. One consequence of this lack of coordination is that infectious disease problems are often approached in a compartmentalized or sequential fashion. For example, problems with potential under- utilization of a vaccine (arising from public or provider misper- ceptions) often are ignored until laboratory studies have been completed. Addressing these problems earlier could save valuable time and improve the public health returns on vaccine investments. Lack of an overall immunization and vaccine development policy does not appear to have greatly affected vaccine regulation. Concern has been expressed, however, that no specific mechanism or forum exists for the systematic review or revision of FDA regulations on vaccines.6 Molecular biology and immunology offer many powerful new research tools and production techniques for biologics. The committee found that no mechanisms exist for the systematic dissemination of knowledge about these advances and their applicability to vaccine development.

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126 Also, no procedures are available to encourage their use in cases in which commercial incentives might be inadequate, e.g., for vaccines of interest to developing countries. Public-Private Sector Interactions In the background papers prepared for this committee, and at the conference sponsored by the committee in November 1983, a variety of concerns were raised about interactions between federal agencies and the vaccine industry. Some of these concerns related to reluctance on the part of industry scientists to discuss current activities, pre- sumably for fear of losing a commercial competitive advantage. This fear may be grounded partly on a belief that it is difficult for the federal government to ensure confidentiality in its dealings with industry. Industry also may refrain from interactions with federal agencies in the research and development phases because of the complexity of federal contracting and reporting procedures. These factors may have played a role in the lack of a commercial response to a NIAID request for proposals to develop an improved pertussis vaccine.7 Concerns about the effectiveness of public-private sector communi- cations also were raised during recent congressional hearings on the events preceding and following recommendations made by the Interagency Group to Monitor Vaccine Development, Supply, and Usage in response to the anticipated DTP vaccine shortage.8~9 Provider and Recipient Perceptions Chapter 3 describes the tendency in the current health care system to emphasize the use of diagnostic and therapeutic technologies rather than preventive technologies, even when the latter have been docu- mented to be highly beneficial and cost effective. This tendency serves as a commercial disincentive for vaccine innovation and pro- duction, and also deprives the public of appropriate health protection measures. Health care providers, with the exception of pediatricians, often are not adequately informed about the benefits of prevention generally, and of immunizations in particular. Also, their percep- tions of the risks of certain diseases and of the relative risks and benefits of vaccines may be inaccurate. These problems have been recognized by various groups concerned with the public's health. Numerous efforts have been made to promote increased awareness, including the development of guidelines on adult immunization by the American College of Physicians.1O These efforts also could lead to more accurate perceptions among the general public of the benefits and risks of immunizations. The committee believes that all potential vaccine recipients (or their parents) should receive (from a health care provider or another appropriate source) accurate information about the risks of vaccine preventable diseases and the benefits and risks of specific

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127 immunizations, including contraindications to vaccination. Accomplish- ing this task will require concerted and coordinated efforts by public health agencies and those individuals and organizations involved in the dissemination of information to health professionals and the public. The role of responsible and well-informed media coverage should not be overlooked. In the past, news reports concerning vaccines have focused extensively on risks perhaps leading to confusion about relative risks and benefits. 1 The media should be encouraged to provide complete, accurate information about all aspects of vaccine development, production, and use in this country. PROBLEMS WITH THE PRESENT SITUATION The problems that arise from the absence of a body to coordinate the attainment of public health goals through vaccine development and use generally are those of omission rather than commission. They include delay or inefficiency in achieving a socially beneficial outcome, and failure to identify or tackle problems in a timely fashion for which no existing group has direct responsibility. The government invests heavily in R&D associated with vaccines and in the promotion of their use; a body charged with general oversight of these processes would help ensure that taxpayers' funds are used in the most effective way possible. Over the past two decades, several situations have arisen that demonstrate the need for such a coordinating body. In all cases, existing agencies or organizations have performed adequately, but the overall results have been less than satisfactory. The first involves the response to public concern over pertussis vaccine. In the mid-1970s, injuries related to the administration of DTP vaccine became a major public health issue in Japan, Sweden, and the United Kingdom. Vaccination policies or acceptance changed in these countries, resulting in resurgence of pertussis. Concern also emerged in the United States; by the end of the decade, the potential importance of an improved pertussis vaccine was clear. Such a vaccine has not been developed, however, in part because no existing organization has the responsibility or the power to set priorities for vaccine improvement. One consequence of this arrangement is that the resources necessary to obtain new knowledge for vaccine improvement are often diverted to tackle other problems (e.g., the control of diseases for which no vaccines exist). Commercial efforts to develop an improved pertussis vaccine have been impeded largely by lack of understanding of the organism and the pathogenesis of the disease. A recent study by another Institute of Medicine group--the Committee on Issues and Priorities for New Vaccine Development--concluded that while the health benefits of an improved pertussis vaccine would be small compared with those of new vaccines for certain other diseases, a pertussis improvement project deserves immediate attention for humanitarian and public policy reasons.12 The second situation pertains to the coordinated development of

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128 vaccines and immunization policies specifically to protect adults from infectious diseases. Although some medical specialty organizations have taken the lead in establishing immunization recommendations for adults, the development of new vaccines for older individuals still may be impeded by the perception that the utilization of such vaccines would be low. The history of the pneumococcal vaccine illustrates one aspect of this problem. The development of a vaccine against this common cause of lobar pneumonia was undertaken during the 1970s as a priority of the NIAID. The anticipated principal target population consisted of high-risk adults, particularly the elderly.13 At that time, substantial evidence (including reports on the use of influenza vaccines) indicated that adults and the physicians serving them were not attuned to the risk of pneumococcal disease (Chapter 3~. Early, coordinated efforts to correct public and physician misperceptions of this matter could have resulted in utilization rates considerably higher than the estimated 10 to 25 percent achieved in the target population once the vaccine's efficacy had been scienti- fically verified.l2'14 (The committee recognizes that, initially, low utilization of the pneumococcal vaccine also may have been due to the scientific controversy surrounding its efficacy.) Concerted immunization and/or vaccine development efforts for adolescents and young adults who may have missed school immunization programs and for health care providers have not yet been undertaken but are highly desirable. The third situation in which the existence of a coordinating body might have allowed more efficient resolution of a serious problem was the development of an improved rabies vaccine to replace one with unacceptably high levels of adverse reactions. Although a vaccine was produced eventually, it appears that inconsistency in support for the project lengthened the development time.l5 Finally, the lack of informed public debate on the relative risks and benefits of U.S. vaccine development and immunization policies suggests the need for a national forum. Public concerns have a legitimate role to play in policy decisions about the relative risks and benefits of vaccines and immunization strategies. Also, the scientists who make decisions in highly technical areas should have access to information about the goals and concerns of those who support and will eventually benefit from their work. The ongoing debate on the optimal vaccination strategy for combating poliomyelitis (while minimizing risks is an example of an area in which a mechanism for broad policy comment could be useful. RECOMMENDATION FOR A VACCINE COMMISSION At the Institute of Medicine Conference on Barriers to Vaccine Innovation in November 1983, several of the working groups recommended that the committee consider a national advisory body. The committee accepted this recommendation for reasons outlined in the foregoing

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129 sections. Its proposal resembles that presented in the National Immunization Work Groups' report, but includes several new elements to reflect the committee's analysis of present needs. Rationale for Establishment A successful immunization program must be based on a consensus among research scientists, developers, producers, program administra- tors, and recipients that the program is needed, that benefits exceed the risks, and that it is practical and feasible. currently, no formal mechanism exists to bring the interested parties together or to provide a forum for debate. Mechanisms for gaining public and professional acceptance of immunization recommendations, especially for adults, also need improvement. One way to accomplish this would be to provide more opportunities for those who administer and receive vaccines to participate in the decision-making process. The commission, as envisioned by the committee, would provide these opportunities. The Secretary of the Department of Health and Human Services, as the individual responsible for policy and legislative initiatives in the health field, also would benefit from such a commission. No existing advisory body has a membership that allows it to present the viewpoints of all participants in the vaccine enterprise. The commission would work to conserve the effective components of the present system; thus, society would continue to benefit from the expertise concentrated in the relevant government agencies, the pharma- ceutical industry, and the advisory bodies described in Chapter 2. These groups would be encouraged to assist in the development of new approaches to sustaining and stimulating commercial interest in production and innovation, ensuring improvement of vaccines, designing clinical and epidemiological research, restructuring liability and A , commission or similar body also would provide an appropriate forum in which to explore applications of new scientific technologies to vaccine development. compensation, and increasing Public and Professional awareness. Purpose and Functions The objectives of the proposed commission would be (1) to advance the control of infectious diseases by promoting the continued innovation, production, and use of vaccines and (2) to ensure that this goal is achieved in a socially responsible and just manner. The commission would monitor all aspects of immunization efforts in the United States, acting in a consultative and advisory capacity; one of its primary responsibilities would be early identification of problems. It also would help to educate and inform the public, physicians, and government decision makers about appropriate immuni- zation actions and policies. AS necessary, the commission would

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130 become an impartial broker to promote production and supply of needed vaccines and to coordinate collaborative activities. Reporting The commission would report at least annually to the Congress and the President, and on other occasions if immediate action is required to avert threats to the public health. Location, Establishment, Membership The base from which the commission operates could have a signifi- cant effect on its ability to fulfill its purpose, which is to identify national needs for vaccine development, production, and utilization and to promote programs to meet the needs. Furthermore, optimal functioning of the commission will require certain attributes that would be achieved more readily under some auspices than others. These attributes include: · Stature and credibility sufficient to command acceptance of commission recommendations. Important factors in this will include: --participation of all relevant parties--government, industry, health professionals, and the public; --the capacity to pursue public health goals in a responsible and just manner, independent of political considerations and commercial interests; --members with outstanding knowledge and experience, appointed without regard to political views; --the capacity to identify solutions to immunization problems independent of the activities and responsibilities of a parent organization. · The capacity to ensure that necessary programs are instituted. This will probably require: --the ability to sustain commission efforts irrespective of fluctuations in the level of political interest in its mission; --the ability to make direct representation to the federal legislature on budgetary matters related to its mission; --the ability to call upon existing federal agencies in the collaborative pursuit of objectives; --the ability to elicit greater industry interest in collaborative efforts than is presently forthcoming, possibly through the use of direct contracts; --the ability to receive funds from any source (e.g., private foundations, industry) and direct them to achieving the commission's objectives. A variety of possible modes of operation for the commission were

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131 identified, some of which have been the subject of previous proposals. It could be established within either the executive or legislative branches, be affiliated with an independent entity such as the National Academy of Sciences, or be created as a federally chartered, nonprofit corporation. Options identified by the committee, and their advantages and disadvantages are listed below: · Creation as a presidential commission. Although such a location would confer high visibility on the enterprise, presidential commissions are often short-lived and can become overly influenced by partisan concerns. This option therefore fails to confer many of the attributes described above. · Establishment within the Department of Health and Human Services (DHHS). This location would give the commission the most immediate influence on existing agencies in the implementation of its recom- mendations. However, interactions between federal agencies and the private sector generally have not exhibited the level of coordination and collaboration that would be required for successful operation of the commission, perhaps because of the complexity of federal admini- strative rules. Additionally, location within DHHS might result in pressure on the commission to modify evolving recommendations in light of other departmental priorities (see the discussion in Chapter 3 of funding requests for a vaccine stockpile). The analysis conducted by the National Immunization Work Groups for the Assistant Secretary of the then Department of Health, Education, and Welfare (DHEW) led to the suggestion that a vaccine commission be appointed by the Secretary (National Immunization Work Groups, 1977~. To date, however, the executive branch has not acted to establish such a commission. Nor has action been taken to create within DHEW/DHHS the broad-based interagency body envisaged by the Office of Technology Assessment (Office of Technology Assessment, 1979~. If a broad-based body were established within DHSS with the appropriate safeguards for its independence and with mechanisms to facilitate interaction with the private sector, it could perform many of the functions the committee envisages for the commission. Its independence from political influence might be still subject to question or misperception because of its location within the executive branch. · Affiliation with the Congressional Office of Technology Assessment (OTA). Such a location would confer the benefits of close association with national policy makers. However, the policy recommending and opera- tional activities of the commission would depart significantly from OTA's traditional role, namely, the identification of policy options.

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132 · Affiliation with the National Academy of Sciences, e.g., association with the Institute of Medicine. Such a location or association would confer the advantages of good access to expertise in pertinent scientific and health related areas, established structure and procedures resulting in recognized indepen- dence of judgment, and an existing federal advisory responsibility/ role on matters of science and health. However, the envisaged policy formulation and promotion, and possible operational activities of the commission are not roles taken up by an advisory organization such as the National Academy of Sciences or the Institute of Medicine. · Establishment as a congressionally chartered, nonprofit corporation. This option would enable the commission to establish an intermediary role between federal agencies, industry, and health professionals without the perception of control by any of these groups. The commission would be in a position to accept funds from federal and other sources and disperse them in an efficient manner. It could maintain an impartial, independent focus on vaccine development and immunization problems and, through reports submitted directly to Congress and the President, draw their attention to issues of concern. It is recognized, however, that some existing quasi- independent corporations serving general public needs have not operated in financially successful fashion due to difficulty in raising funds from private sector sources or revenues. Funding of the commission is discussed further below; but these types of problem, if encountered, could result in overreliance on public appropriations. If created as a nonprofit corporation, the commission's influence on the activities of existing federal agencies and others would derive solely from the persuasiveness of the arguments behind its recommenda- tions. Such a situation could be helpful in ensuring broad and thorough discussion of the issues that the commission identified as needing attention. Public accountability of such a body would be ensured by its creation under congressional charter and the manner of appointment of its members. Based on its analysis of the potential options and its knowledge of the fate of previous recommendations, the committee favors establish- ment of the commission as a congressionally chartered, nonprofit corporation. However, certain other loci for its operations are not altogether incompatible with the purposes of the commission. (It is understood that public and elected officials must consider recommenda- tions in light of the pros and cons of the alternatives as seen from the perspectives derived from their responsibilities.) As envisioned by the committee, the commission would have a relatively small board of directors with members drawn from the fields of biotechnology, immunology, infectious diseases, public health, public representation, health care policy, health care economics, health care delivery, bioethics, behavioral science, law, or medicine.

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133 The manner of appointment should be designed to ensure that the commission attains the attributes of authority and credibility discussed above. In developing a slate of candidates for possible membership on the commission's board of directors, recommendations should be sought from all relevant groups (see Appendix J). Representatives of the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control, the Office of Biologics of the Food and Drug Administration, the Department of Defense, the Health Care Financing Administration, the Veterans Administration, and the Agency for International Development should be appointed as liaison members. Funding Preliminary projections indicate that a budget of about 81 million per year would be required for a minimum level of effective activity by the commission. A federal appropriation would be the simplest mechanism for ensuring rapid establishment of the commission. In the long term, it would be desirable for funding to be obtained from a variety of public and private sources to ensure the body's independence and credibility. Possible Areas of Activity The mode of operation of the commission and its initial activities should be determined by the commission itself. Efforts that might be initiated include (not in order of priority): · monitoring the availability of existing vaccines to anticipate problems resulting from production difficulties or commercial decisions affecting supply · monitoring the need for improvement of existing vaccines and setting priorities in this area · monitoring vaccine innovation activities in the public and private sectors to determine whether they accurately reflect U.S. public health needs and the special needs of the military · monitoring the vaccine needs of developing countries and promoting efforts to meet those needs · evaluating the potential applications of advances in basic biotechnology to vaccine development · evaluating the application of knowledge from the behavioral sciences in the design of campaigns to promote vaccines · reviewing the effectiveness of promotional campaigns · monitoring and evaluating patterns of infectious disease as an aid to determining priorities · monitoring the training of personnel needed to ensure continued vaccine innovation · monitoring and evaluating legal issues related to vaccine development and use

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134 CONCLUS IONS The lack of a formal mechanism to promote cooperation in the innovation, production, and use of vaccines limits the benefits obtainable from existing immunization programs and hampers the development of new programs. The-problems associated with the absence of such a mechanism are primarily those of omission rather than commission: They include delay or inefficiency in achieving desired outcomes and failure to tackle problems for which no existing group has direct responsibility. The history of earlier ad hoc groups convened to address problems related to vaccine availability and use has been discouraging. Specific actions envisaged by such groups have not been implemented for reasons unrelated to their potential utility. When these groups disbanded, attention focused on their activities waned. To overcome these difficulties, the committee recommends the establishment of a national vaccine commission. This commission would monitor all aspects of immunization efforts in the United States. One of its primary responsibilities would be early identification of potential problems affecting vaccine supply. It also would help to educate and inform the public, physicians, and government decision makers about the effects of various immunization actions and policies. When necessary, the commission would become an impartial broker to promote the availability of needed vaccines and to coordinate collaborative activities for which no suitable mechanism exists. Based on its analysis of the options and its knowledge of the fate of previous recommendations, the committee favors establishment of the commission as a congressionally chartered, nonprofit corporation. However, certain other loci for its operations are not altogether incompatible with the purpose of the commission. it should report at least annually to the Congress and the President, and on other occasions if immediate action is required to avert threats to the public health. The committee recognizes that the creation of a vaccine commission should not be undertaken without due consideration; however, it stresses the need for rapid action. Failure to act on earlier proposals has contributed to the growing severity of problems of vaccine supply and innovation. REFERENCES AND NOTE S 1. National Immunization Work Groups. 1977. Reports and Recommendations of the National Immunization Work Groups. McLean, Va.: JRB Associates. 2. U.S. Congress, Office of Technology Assessment. 1979. A Review of Selected Federal Vaccine and Immunization Policies. Washington, D.C.: U.S. Government Printing Office. _ _ __

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135 13. Mason, J. 1984. Testimony on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 4. The Social Security Act Amendment of 1980, P.L. 96-611, December 28, 1980. 5. U.S. Congress, Office of Technology Assessment. 1980. Compensation for Vaccine-Related Injuries: A Technical Memorandum. Washington, D.C.: U.S. Government Printing Office. 6. Cohen, P. 1983. An Overview of the Factors Which May Impede Public-Private Sector Relationships Affecting Vaccine Development and Use. Paper prepared for the Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28-29, 1983, Washington, D.C. 7. Jordan, W.S., and Galasso, G.J. 1983. The Interaction of Federal Agencies and Pharmaceutical Companies in Vaccine Development. Paper prepared for the Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28-29, 1983, Washington, D.C. 8. U.S. House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment. Hearings held December 19, 1984 on H.R. 5810, Washington, D.C. 9. Centers for Disease Control. 1984. Diphtheria-tetanus-pertussis vaccine shortage--United States. Morbid. Mortal. Weekly Rept. 33:695-696. 10. American College of Physicians, Committee on Health and Public Policy. 1985. Guide for Adult Immunization, 1st ed. Philadelphia: American College of Physicians. 11. Collins, C., and Hanchette, J. December 1984. The Vaccine Machine, A Special Report. Washington, D.C.: Gannett News Service. Institute of Medicine. 1985. New Vaccine Development: Establishing Priorities, Volume 1. Diseases of Importance in the United States. Washington, D.C.: National Academy Press. Austrian, R. 1983. The Development of Pneumococcal Vaccine. Paper prepared for the Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28-29, 1983, Washington, D.C. 14. U.S. Congress, Office of Technology Assessment. 1984. update of Federal Activities Regarding the Use of Pneumococcal Vaccine. Washington, D.C.: U.S. Government Printing Office. Mitchell, J.R. 1983. Vaccine Development Incentives and Disincentives. Paper prepared for the Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28-29, 1983, Washington, D.C. 16. Institute of Medicine. 1977. Evaluation of Poliomyelitis Vaccines. Washington, D.C.: National Academy Press.