Predictive medicine employs multiphasic screening techniques, both to determine the true measures or standards of health for individual persons, and to detect significant deviations from these standards at the earliest possible time. Dr. Cheraskin will expand on this definition when he discusses his predictive medicine program.

In our work as measurement specialists, we also use the term "predictive health" to focus our attention on the ultimate goal of these efforts. We find it useful to think in terms of measuring health and deviations from it, rather than in terms of disease and the extent or seriousness of it. In the context that we use the terms, "predictive health" and "predictive medicine" complement each other.

Predictive medicine and predictive health are based on the concept that measurable changes-biochemical and physiological-occur in the body's metabolism before the onset of overt disease. Multiphasic screening for a variety of parameters makes it possible to detect and chart these changes which may occur months, or even years, before the appearance of many presently accepted clinical indicators of disease. Thus, it is possible to measure and evaluate the transitional state between health and disease. Given this information, in most cases it is possible to initiate appropriate corrective measures. In his remarks, Dr. Cheraskin will discuss this phase of the predictive medicine program, as well as the use of health education programs designed to maintain optimum health.

The concept of detecting disease in its early stages has been known to medical science for many years. However, it is only recently that measurement science has begun to provide the physician with highly sensitive and selective means for detecting and measuring the physical signs of potential difficulty. In the measurement phase of predictive medicine, we are concerned with some extremely subtle biochemical and physiological phenomena. For example, instruments and measurement techniques are now available which make it possible to measu're certain biochemical materials in concentrations of a few parts per hundred billion or a few parts per trillion. These advanced techniques, and others now being developed, will play an increasingly important role in the tracking of metabolic trends that presage illness. In addition to advanced analytical techniques, predictive medicine also involves the use of computation and data processing equipment. Large numbers of individuals must be monitored at regular intervals for a variety of parameters. Information from these periodic tests must be updated and correlated with background data already available to establish meaningful health criteria for each individual. The objective is an accurate health profile for each individual which will serve as the standard against which his continuing health, or deviation from it, is measured. With such large volumes of data to be processed, the computer plays a significant role in predictive medicine.

In consulting with Dr. Cheraskin on the Los Angeles predictive medicine program, we have employed the modern planning technique of systems engineering. This technique, developed to implement large-scale aerospace and industrial programs, has proven to be readily applicable to complex medical programs. It involves four basic phases: analysis of requirements, program definition and design, initial implementation, and, finally, operations implementation. These

four phases are charted in detail in the material which has been submitted to the subcommittee.

The Los Angeles predictive medicine program has reached the operations implementation phase. Dr. Cheraskin, the medical director, will now discuss the program for you.

(Dr. Weber's statement follows:)

THOMAS B. WEBER, PH. D., CURTIS E. MILLER, M.D., BECKMAN INSTRUMENTS, INC., FULLERTON, CALIF., IN COOPERATION WITH EMANUEL CHERASKIN, M.D., D.M.D., MEDICAL DIRECTOR OF THE PREDICTIVE MEDICINE PROGRAM OF THE RETAIL CLERKS LOCAL 770 AND FOOD, DRUG AND GENERAL SALES EMPLOYERS BENEFIT FUNDS

THE PREDICTIVE HEALTH PROGRAM

As a representative of measurement science, we appreciate the opportunity to review the concept of Predictive Health and the progress now being made to implement the concept.

We shall begin by defining Predictive Health and showing how it fits into the multiphasic screening concept. Multiphasic screening is applicable to the transi tion from health to sickness. One aspect of Preventive Medicine is concerned with the early detection of disease by multiphasic screening and has as its function the treatment of subclinical disease to avoid serious sickness. Predictive Health is concerned with the measurement of health by detecting the very early changes in the body that could lead to diseases. Therefore, Predictive Health and Preventive Medicine complement each other.

Impetus has developed in the medical community for the prevention of metabolic and systemic disease by screening individuals prior to the deterioration of their health and the onset of subclinical disease. But, it is only recently that measurement technology has enabled the clinician and public health scientist to measure precisely the early and latent stages of degenerative diseases. As a result of new and improved techniques for the measurement of subtle changes in the body, we may now talk about the Prediction of Impending Disease.

To make Predictive Health a practical part of multiphasic screening, a rational and effective program must be developed. As measurement scientists working with the medical community, we are able to apply to Predictive Health programs the sophisticated program planning technique-systems engineering. Systems engineering has been refined by industry and government technical and management organizations as a tool for achieving control over the complex problems associated with national defense and the space program.

Predictive Health is based on the concept that, prior to the onset of overt disease, minute changes occur in the biochemistry and physiology of the body. There is a transitional state which separates health from disease. The beginning of this transitional state, which is the true beginning of disease, is the result of the inability of the body's defenses to react properly to an external or internal threat or challenge.

We must then look seriously at the state of man in terms of his basic adaptive and defensive mechanisms and, through precise health measurements, determine meaningful changes that could lead to disease. This forms the basis for developing the actual monitoring programs and determines the procedures and the instrumentation which will be required.

A successful Predictive Health program depends on multiple monitoring phases. Each monitoring establishes historical, behavioral, physiological, and biochemical parameters. This means that a large number of parameters are monitored and, after periodic testing, predictive trends begin to appear. These predictive trends are useful to the physician in taking steps when significant changes are observed. This leads to the health education phase of the program. In addition to early preventive measures which can be provided through changes in diet, activity, etc., the public must be made aware of the importance-and the waysof maintaining health. We consider thorough health education to be equal in importance to any other aspect of the program.

SYSTEMS ENGINEERING APPROACH

Basically, systems engineering is a scientific discipline for designing, developing, and operating complex programs. The elements of this approach are analytical in nature and make ideal tools for the solution of complex medical problems.

The systems engineering approach makes it possible to plan programs with proper emphasis on individual phases and their interrelationships prior to actual implementation of the total effort. A principal objective in systems engineering is the attainment of optimum program operation with minimum trial-and-error evaluation after implementation. There are four basic phases to such a program: I. An Analysis of the Requirements II. Program Definition and Design III. The Initial Implementation IV. Operations Implementation

With the realization of all four phases, the program will become fully operational.

PROGRAM IMPLEMENTATION

Phase I-Requirements Analysis

The two most important questions to be asked are: 1) What objectives are to be accomplished? 2) In what order must they be accomplished? Figure 1 shows the first of four general flow diagrams used to chart and maintain program growth. Each major objective in this first phase is laid out and specific tasks are assigned to the individual program team members.

This procedure establishes all requirements of the program necessary to accomplish the stated objectives. It is valuable, too, because the analytical approach clearly defines realistic objectives and determines whether or not they are consistent with program goals, operational constraints, and program economics. Phase II-Program Definition and Design

This phase translates the program requirements obtained during Phase I into designs and specifications for facilities, equipment, material, and operations as shown in Figure 2. Additionally, over-all program trade-offs are performed so that a final, optimized program design can be established. Phase II provides the final program definition.

Phase III-Initial Implementation

During this phase the program must be brought to operational status. Fig. ure 3 shows four main flow lines: personnel requirements, logistic requirements, acquisition bid proposals, and final program management parameters.

Phase IV—Operations Implementation

When Phase IV is completed, the program will be fully operational. As can be seen at the beginning of Figure 4, facilities, personnel and equipment have been brought to operational status. The staffing requirements are now completed and a final checkout is made. In the final checkout, volunteer subjects are tested and the results are used to verify the operational procedures, or modify them as necessary. When this is completed, the program becomes fully operational.

SUMMARY STATEMENT

Up to this point, we have discussed the concept of Predictive Health and the approach used to establish an operating program. We have placed major emphasis on concept. At the present time, the concept of Predictive Health is being translated into reality in Los Angeles where the Retail Clerks Local 770 and the Food, Drug and General Sales Employers Benefit Funds have established a Predictive Medicine Program. Beckman Instruments, Inc., has served as management and technical consultant in the design and implementation of the program. The medical director of the program is Emanuel Cheraskin, M.D., D.M.D. In his statement, he will describe the program for you.