Clinical Immunology Society: The Early Years 1984 - 1989

A. 1984-1985 - Concept and Consultations

Preparing for and developing the Clinical Immunology Society (CIS) was somewhat analogous to building and outfitting a ship that would be seaworthy and functional. The first step was to indicate the purpose of the ship and what it would do. The second part was to settle on a general design or pattern and then identify the materials needed for construction of the vessel. (The materials can be assembled into a ship to be launched and then proven to be able to float.) Such a ship would need a power and propulsion system. Finally, a steering and navigation system would be installed to control the ship’s direction and see that it followed useful courses that met the intended needs in a timely and effective manner. In the three years leading up to the first meeting of the CIS and in its first year or two of operation, most of the activities noted in the ship sequence were carried out.

The initial concept was that the CIS would, (1) promote research, i.e., facilitate the acquisition of new knowledge and the improvement in the diagnosis and therapy of disease, and (2) foster improved education and training and aid in the translation of research advances into clinical practice. In 1984, and even earlier, consultations began about the concept of the CIS, which would be independent from but also relate effectively to significant existing organizations. Leading immunologists (Table I) were consulted regarding the advantages and disadvantages of a separate society and what it should do to advance both research in and the practice of Clinical Immunology.

Four general areas were considered for involvement in its successful development: (1) Academic Immunology (including industrial laboratories) that were contributing research advances and knowledge of the immune system components, functions, and regulation; (2) Clinical disease specialties and subspecialties, in which training and continuing medical education in the field were needed for the benefit of patients; (3) Medical Laboratory Immunology resources necessary for good clinical practice and clinical research; and (4) Partnership with the NIH, especially NIAID and the AAI and other professional organizations in advancing these efforts.

1. Academic Immunology – Research Advances Focused on Immune System Components, Functions, and Regulation

Much immunological research was done in experimental animals, particularly mice and rabbits. However, the reagents required for comparable measurements in humans needed to be developed, understood, and made more widely available. The process was well underway, but many researchers, especially laboratory scientists, did not have ready access to human material to study. Many concentrated on animal (especially murine) systems for conducting research on the development and functions of the immune system. Animal models allowed for a greater variety of research studies and for the control of parameters and genetic factors than were possible in the more diverse human population.

Yet, human disease provided striking opportunities for research in Immunology. A prime example is the immune deficiency defects seen particularly in pediatric populations. Also, autoimmune diseases presented many challenges, as did transplantation immunology, in which replacement organs needed to be protected from rejection. In addition, there were opportunities for providing new immune systems by means of bone marrow (lymphoid stem cell) transplantation.

Academic Immunology research broadened substantially when it became more than simply diagnosing and responding to infectious diseases. It began to be concerned with overall problems of homeostasis and immune regulation and replacement and to capitalize more broadly on research opportunities presented in human populations for the treatment of cancer, autoimmune and other diseases.

AIDS presented new challenges for Clinical Immunology research in the 1980s. There was no known animal counterpart. Simian Immunodeficiency Virus (SIV) was only identified later and was not a widely available research tool. Thus, AIDS, with eventual lethal damage to the immune system, also demonstrated that the immune system converted what could have been an acute lethal disease into a long-term disease with ten or more years of survival in some persons without an effective antiviral treatment. This result emphasized the power and value of existing immune responses and the need for better specific immune containment of HIV, the lentivirus that causes AIDS. The challenges for HIV vaccine development were already evident.

Individuals doing laboratory research were consulted to solicit their participation and asked how a Clinical Immunology Society could promote their interest. Providing assistance in making available human samples for research analyses was noted. Also, clinical validation and evaluation of hypotheses and theories developed in in vitro or animal studies needed to be facilitated.

2. Clinical Disease Specialties and Subspecialties – Involvement of Immunologists

Clinical specialties and subspecialties already existed, based largely on specific organ systems. Each presented some immunological challenges. Suggestions about how the CIS could foster advances in the recognition and treatment of diseases were solicited. Eventually, interested professionals in 15 clinical specialties had been consulted (Table I). By and large, they welcomed the opportunities for improved contact with advancements in Immunology, for access to research reagents and techniques, and for opportunities to explore new therapies.

In the field of Allergy Medicine, two organizations, the American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) had included Immunology in their names but focused mainly on the clinical practice of allergy. They had, however, fostered education and certification programs in their field in the form of a conjoint board (American Board of Allergy and Immunology – ABAI), under both the Medicine and Pediatrics boards. Efforts to relate allergy to the new Immunology were ongoing. (See section D).

Medical specialty meetings usually included some Immunology reports, but most emphasized other areas of the clinical specialties and not the broader reaches of Clinical Immunology, which might be applicable to the problems and treatments associated with disorders of too little or too much immune response. Clinical Immunology training and certification could be conducted as a distinct specialty or linked to an established field such as Rheumatology, Allergy, Oncology, etc. Clearly, it was an area to be resolved, and the CIS could support appropriate developments. There was the hope that having Clinical Immunology meetings would not compete with the specialty meetings but rather promote advances in both directions; for example, Rheumatology experience in immune suppression would be relevant to immune modulation in other clinical areas with too much or inappropriate auto immunity.

3. Immunological Laboratory Resources Needed for Clinical Research

Immunological laboratory resources needed for Clinical Immunology were not well-focused or readily available in hospitals in the 1980s. The available tests were scattered among Hematology, Chemistry, and Microbiology laboratories with fluorescence microscopy in Pathology (or only in research laboratories). In addition, conventional testing was often conducted by individuals not trained in Immunology. There were new procedures to be codified and normal ranges to be defined. Immunologists had developed their own laboratories to make the measurements needed for clinical research. Advancing clinical immunology required methods being developed in research laboratories – but not yet incorporated into the rubric of hospital pathology.

Training in Medical (Clinical) Laboratory Immunology needed to be developed. The status quo was no longer sufficient. In those years, procedures were often done on a small scale. Several test samples and control or reference samples might be evaluated in a typical assay, and immunological assays, for the most part, were not adapted to large-scale, check-list machines. A certification program initiated by the American Board of Allergy and Immunology conducted its first examinations in 1986; however, only M.D. trainees could be certified. The American Board of Medical Laboratory Immunology (ABMLI) sponsored by the American Society for Microbiology (ASM) was available to certify qualified Ph.D. as well as M.D. candidates. Clearly, an effective immunology society could contribute to developments and training in the medical laboratory areas that were essential to quality clinical practice and research in Immunology. Discussions with leading medical immunology laboratory professionals provided assurance that state licensure issues could be accomplished along with recognition and financial compensation for the immunological testing conducted in clinical contexts.

4. Procedures and Therapies Requiring Special Expertise Unique to Clinical Immunologists

These are summarized in an outline prepared in 1986 by Richard O'Reilly (see Table II).

5. American Association of Immunology (AAI) and Other Organizations, National Institutes of Health (NIH), Especially National Institute of Allergy and Infectious Diseases (NIAID)

For some years, the AAI considered how to relate to Clinical Immunology and had developed a working group on Immunopathology. The CIS included Immunopathology within its framework but also had a great interest in immunotherapeutics. AAI was not active in promoting the field beyond having the topics included in its annual meetings; however, it offered assistance and expressed interest in continuing contact. Immunologists working to develop the CIS talked with AAI leadership frequently during this period. (See Section D.)

A crucial agent for development and support in all of biomedical research was the NIH and the NIAID, especially for Immunology. NIAID was concerned that advances in knowledge should be applied to human disease and its prevention and treatment.

Richard Krause, who was the Director of NIAID at that time, and his successor, Anthony Fauci, were strong supporters of Clinical Immunology research. Some funding was available for Clinical Immunology research training programs, for conferences on research advancements, and for other devices to improve and strengthen research in this arena. Robert Goldstein and Bernard Janicki managed these programs in the Allergy and Clinical Immunology Branch within the extramural NIAID.

Other Institutes at NIH also contributed. In the 1980s, the NCI had a larger overall budget than NIAID and had been, for more than a decade, actively supporting immunology research both in-house at the NIH and through grants. Research on immune mechanisms had potential applications to many issues raised in cancer research. Other NIH Institutes also contributed to the support of Clinical Immunology in their particular organ or disease responsibilities. There was good communication at the NIH and cooperation between all the Institutes in this area.

6. Meetings to plan a Society and Annual Conference

More than 50 persons in Clinical and Basic Immunology research and/or active in one of the medical specialties were consulted about the possible value and implications of having a CIS (Table I). Overall, there was substantial support, with many of the consultations occurring at national and international gatherings of immunologists – from those of the AAI, of the American Society for Clinical Investigation (ASCI), and the American Association for Clinical Research, at the council meeting of NIAID, the AIDS research conferences, and the British Immunology Society meetings in 1984 and 1985. These were places where Clinical Immunology was a focus of research and applications.

On January 23, 1986, I hosted a dinner meeting held at the Chevy Chase Club in Maryland, relatively close to the NIH. The attendees included Noel Rose, Baruch Benacerraf, Tom Waldmann, Allen Kaplan, Henry Metzger (AAI representative) and other immunologists attending an NIAID Council meeting at the NIH. Several emphasized the value of an academic society focused primarily on research, while others envisioned that the CIS would be an opportunity, also, to build clinical (and laboratory) training and practice in the various contexts of Clinical Immunology, particularly new therapeutics.

A larger planning meeting was organized for May 6, 1986, in conjunction with the American Society for Clinical Investigation (ASCI) Conference held at the Sheraton Washington Hotel in D.C. Those present included Drs. Fahey, Rose, Fathman, Fauci, Waldmann and Janicki; and, Drs. Barton Haynes, Dale McFarlin, Fred Rosen, Warren Strober, Norman Talal, Kirk Osterland, Gary Hunninghake, Lawrence Lichtenstein, Peter Schur, and Allen Kaplan.

• A review of existing organizations indicated that some of the clinical specialty meetings included clinical immunology components, but none brought together a full range of relevant advances in the science and clinical applications of immunology.
• Membership was discussed, and the general desire was to include M.D. immunologists who identified with Clinical Immunology as a major activity as well as clinical investigators in other fields who use immunological interventions or immunological methods to assess treatments of disease. Furthermore, such immunologists should have roles in the development of the organization as well as in the planning of meetings.
• Also, Ph.D. immunologists who work with human disease or in animal systems relevant to human disease should be included in the membership.
• The organization should be separate as a free-standing society, but it should associate as closely as possible with the AAI. Other frameworks were discussed but those present unanimously favored a distinctive organization, not just a division or affiliate of AAI. Although the AAAAI met specific needs of academic and practicing allergists, a separate organization in a much larger modern context of Clinical Immunology was required for many different, but somewhat overlapping groups within this broad field.
• The term that best described this organization was the "Clinical Immunology Society."
• The development of a recognized medical specialty in Clinical Immunology, however, was less certain. Almost all the M.D.s who saw patients had clinical training and certification in a conventional specialty and subspecialty. It was not clear how training and certification in Clinical Immunology could be related to existing specialty fields such as Rheumatology, Oncology, or Dermatology. Their patient referral patterns were well-established. AIDS was less certain. However, the patients of most allergists, oncologists, and others did not want AIDS patients in their waiting rooms in the 1980s, when there was great fear of that disease.
• Hyphenated terms, such as immuno-rheumatologist, were reasonably accurate but cumbersome and generally not used.

7. Decision to Proceed

The general preference by early 1986 was for a research society that would promote clinical and laboratory collaborations, report advances in the field, and foster pathogenesis and therapeutic research. Most physicians indicated a willingness to contribute to the development of a specific identity for Clinical Immunology.

An initial two-day scientific meeting later in 1986 was outlined to include symposia, simultaneous mini-symposia, and posters and poster discussion groups. The time of the year and location were considered. The options were two days before the AAI meeting in spring 1987 or a two to two-and-a-half-day independent meeting in October 1986 in Washington, D.C., or Baltimore. These locations were favored because of the conjunction of many clinical immunologists at the NIH and at academic institutions who could easily attend a meeting relatively close to home and work. The Steering Committee of the working group was charged to carry out this latter arrangement with assistance from the Planning Group.