Subject: A Time for Change Date: Feb 1993 (416 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Project Inform P E R S P E C T I V E &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Permission granted for non-commercial use. A Time for Change AIDS research, now entering its second decade, is at a crossroads. Despite substantial advances which have extended survival times, no treatment is uniformly or dramatically effective. Some argue that this should have been expected in a major disease like AIDS, as decades of work have yet to conquer cancer or many other serious illnesses. Yet there is little doubt that the fight against AIDS could be better managed. With a new administration taking the reins in Washington, there has never been a better opportunity to implement reforms and initiate new programs. Three key initiatives, one already underway, may light the way to a more hopeful future: 1. Strengthening the Office of AIDS Research (OAR); 2. A Call for an Independent Assessment of AIDS Research; 3. Opening a 'second front' in the war on AIDS. Initiative #1: OAR Reform If one word characterizes the last several years of AIDS research, it would be "unmanaged." It is fair to argue that no one has really been in charge of the overall effort, and thus no one is truly accountable for anything. One of the most obvious problems has been a lack of coordination and strategic planning. It is no one's job to systematically follow-up on the new leads and insights generated each year. No one is responsible for finding the common threads which might link the work of hundreds of scientists working in isolation. Because no one is in charge, no one is responsible for making sure the right experiments are done to answer key questions and test new theories. To a large degree, each of the hundreds or thousands of researchers working in AIDS is simply doing his or her own thing, pursuing self-selected paths and often competing, rather than collaborating, with each other. This is not due to malice or lack of concern -- it is simply the tradition of medical research. Major institutions like the National Institutes of Health have long operated on the principle of investigator- initiated research, a process in which individual researchers apply for grants to do the work they believe is necessary. The only real direction-setting occurs when the leadership invites applications for study in particular subject areas. While this is helpful, it is a very imprecise tool, one which at best only gives gentle direction. There is no strategic plan to coordinate or guide research efforts toward common goals. Currently, US AIDS research is directed by the Office of AIDS Research of the National Institutes of Health. This office has the power to influence, but not control, research throughout the many Institutes. In a sweeping series of reforms proposed by New York's Treatment Action Croup (TAG), this office may be greatly strengthened in future years. If the legislation passes as planned, the newly invigorated Office of AIDS Research will: * work with the Institutes to establish an overall strategic plan and objectives for all AIDS research funded by the federal government; * work with the Institutes to create an annual bud get which implements the strategic plan; * distribute funding according to the plan and negotiate any necessary changes with the Institutes, in keeping with the strategic plan; * evaluate the overall performance of the federally funded groups working on AIDS; * manage a "discretionary fund" for special needs and new opportunities as they occur. Together, these reforms should go a long way toward creating a greater sense of focus and unity of purpose in AIDS research. Moreover, it should give the public greater confidence that the effort will be well-planned and well-managed. While the reform package was not yet fully approved by the Congress as of publication date, differences of opinion were rapidly narrowing and were limited mostly to the question of funds disbursement after bud gets are approved. In effect, this says that the notions of stronger management, centralized strategic planning, and meaningful program evaluation are already agreed to. This is no small matter, as the research community is unaccustomed to many of these concepts. Once passed, these reforms should help optimize the federal research bureaucracy and at least create the opportunity for stronger leadership. Initiative #2: An Independent Assessment The Office of AIDS Research reform package lays the framework for improvement in the fight against AIDS. Once new processes are in place, however, the second challenge is the substance of reform. In this regard, there is no shortage of opinions. Researchers, physicians, patients, politicians, and activists alike have their views on what has been wrong with past efforts, and what to do next. While some of these views are complimentary, some others are quite contradictory. While everyone has opinions and biases, no one has a lock on the truth. One of the reasons for this lack of clarity about where we stand is that the AIDS research program has been essentially unevaluated for the last 8 years. No serious assessment has occurred, despite the overall size and importance of the program. Thus, before the next major step is taken, Project Inform is calling for a high level, independent assessment of AIDS research, an assessment which would address both scientific and management issues. To be effective, it must be done by a "blue- ribbon" panel of scientists and management experts, and practical thinkers. The panel should be appointed by the President, not from within the National Institutes of Health, nor even within the Department of Health and Human Services. What would the 'assessment' process do?? * Constructively assess the strengths and weaknesses, successes and failures of the first decade of AIDS research, not to blame or laud anyone, but to provide a basis upon which to build new initiatives. * Define the state of our knowledge of AIDS, across several broad scientific fronts. * Define key unanswered questions which lie ahead, as well as suggest general priorities. * Identify the principle bureaucratic, management, legal, and economic obstacles which might be hindering progress. * Make recommendations for the second decade of AIDS research, including giving direction to any special new research program which might be initiated. Properly managed and given sufficient priority within the government, the committee process and recommendations could be completed in six months or less. Once completed, presidential authority would be required to implement the Committee's recommendations. This proposal is not a call for just "another committee" or "another commission." For the first time, the fight against AIDS has the support of the President. It is not unreasonable to expect that this could be a committee with genuine teeth. Previous well-intended efforts, like the two prior National Commissions on AIDS, were paper tigers because the administration which created them never had any intention of acting on their recommendations. They were essentially public relations exercises by the Administration, no matter how hard the Commission members tried to make them otherwise. Moreover, the prior Commissions did not focus on questions of AIDS research, nor were they qualified to do so. Despite concerns over the possible time an assessmellt might require, and despite fear that its recommendation might not be followed up, such an assessment is an essential step for future progress on AIDS. Before any bold new initiatives can take place, it is critical to build a consensus about what has taken place previously and what should happen next. New directions neither can nor should be dictated, no matter what their source. Even though many groups have their own visions for the future, and most sincerely believe their own plan to be the best, there are far too many lives at stake here to gamble on anyone's individual view. Scientists, politicians, physicians, activists and patients alike are aU individually capable of being wrong. It is only by working together through a process of assessment and consensus building that we can go forward with reasonable assurance we're on the right track. Without it, the risk of error is high, and the risk of crippling disunity is near certain. Initiative #3: Open A Second Front Some researchers argue that science cannot be managed like a military operation, that creative minds must be given freedom to explore without excessive direction. They point out that a powerful centralized program could go off on the wrong track and waste aU its resources and authority. Perhaps, perhaps not. The same challenge is faced in any kind of a major project working in unknown territory. But this concern must be balanced against the fact that AIDS is an infectious, deadly epidemic, not an exercise in academic freedom. At the very least, a somewhat more managed and better controlled effort must be possible and must be tried. What could be less promising than ten more years of the same kind of AIDS research? Many voices have long called for a special, focused research project on AIDS, frequently called a"Manhattan Project," the name taken from the famed project which sent hundreds of top scientists off to Los Alamos, New Mexico, to build the atomic bomb during World War II. Some people believe that a similar approach is the only thing which will ever solve the problem of AIDS. For many reasons, direct comparison to the Los Alamos project of 1943 is inappropriate. However, it has become a truism of modern business and contemporary project management theory that certain tasks are best done by smaller groups of highly skilled, highly motivated people working in teams, freed from the normal bureaucratic overhead. Innovation and flexibility are simply not characteristics of bureaucracy, and the current AIDS research program is certainly a bureaucracy. Thus, just as the military employs "skunkworks "operations and "rapid deployment forces" for critical projects, just as General Motors created the small nimble "Saturn" corporation for making a new line of small cars, it may be appropriate to spin off certain key aspects of AIDS research to a new kind of rapid-response facility. What's Needed? Calling for a complete dismantling of the current AIDS research effort and replacing it with a "Manhattan Project" would be politically futile and probably scientifically unwarranted because of the many uncertainties which still exist. Much of the work underway today will be needed no matter what new approaches are tried. Moreover, the efficiency and value of that work will almost certainly be enhanced by the Office of AIDS Research reform package. Thus, a "second front on AIDS" is likely to be an offshoot of the current federal AIDS program, rather than its replacement. Yet, there are many reasons to believe a far more directed and intensively focused research effort might pay special dividends in certain aspects of AIDS. These might include the development of such budding new technologies as gene therapy, antisense therapy, and immune system regeneration. These critical areas will eventually be addressed within the broader context of AIDS-research, but perhaps not as quickly as might be possible in the setting of a more specialized program. Such a program would differ from the normal processes at the National Institutes of Health in several key ways: * Leadership and a strong chain of command would be established, with a clear decision-making structure and lines of accountability, modeled after industry or military project management styles, rather than the typical science management approach. * A team would be created including diverse top scientific minds and creative thinkers. Such a project could employ a certain type of person, one who knows how to get things done while meeting the conflicting needs for personal autonomy and leadership authority. * Program administration could be left in the hands of experienced civilian administrators, rather than wasting the time of scientists with administrative duties (as is now so much the case in the federal AIDS program). Keeping the scientists out of administrative posts would also diminish inappropriate forms of competition between them. * At least a core of top scientists would come together at a single location, from which they could work in collaboration with others linked to them in a "distributed" institute. Much of the need for relocation in the original Manhattan Project was for security reasons, but it also provided great payoffs in team spirit, efficiency, and group focus. * Scientific makeup of the team should include pathologists, lab scientists, virologists, immunologists, and clinicians, each with appropriate support staff. By combining laboratory and applied skills in a single setting, testing, evaluation, and adjustment could be greatly speeded compared to the current system, which establishes artificial barriers between these functions and requires separate levels of approvals each time a project moves on to the next step. In the history of medicine, most breakthroughs have occurred through the work of such integrated teams. * Key to the concept is the notion of "emergency powers:" the team would be empowered to work in unique ways currently not possible under the spider's web of federal regulations affecting medical research. This would include: -- a special cooperative relationship with regulatory authorities, providing the greatest degree of experimental freedom and minimal unnecessary oversight; -- access to the broadest possible range of public and proprietary technologies and products, using, if necessary, the legal justification of "eminent domain" (a practice in which government sometimes controls or seizes otherwise private property or goods, for the national good) * The team would be responsible to a single institutional review board. All levels of experimentation, including clinical research, would be conducted without additional oversight from the FDA or the myriad of review bodies which currently hamstring NIH and university/academic research. * The entire team would be driven by clear, limited goals, and held accountable to them. Accountability, however, would be measured by achievement of the goals, not by compliance with paperwork and needless regulations, as is now the case. * Resources would be allocated on a long-term basis, as is often done for military programs. Minimizing the annual budgeting process would increase the efficiency of researchers. * Most importantly, the group and any subgroups would function as teams, working together from the same operating plan and working to achieve group goals. The groups would carry experiments through from laboratory observations to clinical testing within a single team, with overnight capability to move back and forth between the lab and the clinic. Such an approach is not only the most efficient, but also the most effective and most satisfying for the scientists. * Leadership would have direct access to the highest civilian authorities, including the President of the United States. * The entire team, not individuals, would be credited for accomplishments. By giving up the right to individual patents and personal publication credit, senior-most scientific personnel would encourage collaboration and diminish inappropriate forms of competition. Such an arrangement of personnel and policies would utilize our best scientific minds under the systems and procedures most likely to produce results. However rational this sounds, it is quite unlike the ways in which AIDS research is currently conducted. Such a program, of course, would be an experiment, and as such reviewed frequently to determine whether or not it is producing results. Wishful Thinking? All of this, of course, is dependent upon achieving the political will to take a new direction in AIDS research, one based on acknowledgment that AIDS is an emergency which deserves the highest national attention. Despite a lot of rhetoric, AIDS does not today have this position, nor does any other health care problem. Government can act decisively when it wants to. Witness its response to such events as the 1989 San Francisco earthquake or Hurricane Andrew. Even though only a relatively small loss of life was involved, compared to AIDS or other major diseases, billions of dollars of federal support funds were appropriated within days, with nary a peep from Congress or the public. No one denies the suffering caused by these events. But by far the largest price the government will pay in response to these events will go toward the restoration of property -- not life or health. In comparison, the death toll from AIDS alone already exceeds that of US citizens in wars in the Gulf, Korea, and Vietnam combined. By decade's end, there is little doubt that the toll will exceed that of all combined wars in US history. As in war, most deaths will occur among the young, people who were expected to contribute to society for decades to come. Is this not sufficient reason to declare an emergency and try something new in the "War on AIDS"? If the will can be found in the new Administration, all the other pieces are already in place to begin such a program, including a facility to house it. The Frederick Cancer Research Center, a privately managed research facility closely associated with the National Cancer Institute, has an empty, 50,000 square foot facility designed for AIDS research. It currently sits empty and unused. Management and direction of the complex, which includes some of the most advanced laboratory facilities in the world, is currently open for discussion due to the recent death of its chief administrator. Senior scientists, along with a new generation of creative thinkers, are ready and able to open a second front against AIDS. Because of the Frederick facility, little money would be needed to create new labs or purchase new equipment. It is all sitting there, much of it unused or not used to capacity. The Clinton Administration has dropped broad hints of its interest in making a bold stand against AIDS, even though it is limited by financial constraints. A limited, focused research program like that conceived here could be funded for $50 to $100 million annually, a very modest additional expenditure on top of the existing AIDS research budget. By limiting the scope of the new program, no feathers need be ruffled in the existing research program, which itself will proceed in an improved fashion thanks to the impending Office of AIDS Research Reforms proposed by TAG. Only three things are needed to initiate a program such as this: * a consensus, built upon assessment of needs * a national agreement to put an end to AIDS * a financial commitment from the Administration and the Congress The ideas presented here are, of course, but one way of looking at the problem. What should be clear to all, however, is that there is currently no real "War on AIDS" and that the present effort to conquer the disease is in no way guided by the organizational and strategic thinking which directs our other most pressing emergencies. AIDS is an enemy which can be beaten, but to date, we are fighting with tools designed for another task. The sense of urgency, which seemed once shared at least by some researchers and political supporters, has never seemed more lost than it is today. Whether it is through reforms of the Office of AIDS Research, the "special project on AIDS" envisioned here, or both, we can definitely move faster, more efficiently, and more productively, but not until the nation develops the will to do so. &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display