RESULTS OF THE WORK OF CONSULTANTS IN THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Consultants in the Department of Health, Education, and Welfare serve as an important link between the Department and non-Government personnel, both within the professional and scientific community and among the public at large, who share our interests and concerns. Services rendered by these individuals vary widely from program to program; but, in general, consultants are appointed for the purpose of functioning in one or more of the following capacities: a. To provide to HEW professional staff and program managers expert, and often highly specialized, advice and recommendations on the planning and conduct of specific programs and projects. b. C. To serve as members of advisory councils or committees to assess the nature and extent of c-going research, study and make recommendations on highly technical problems, or provide advice and recommendations on the content and direction of general policy and long-range planning for Department programs. To serve as members of review panels to study the safety and efficacy of certain drugs or of study sections to review applications for grants-inaid relating to studies in the various fields for which this Department has responsibility. The examples shown below of services rendered by consultants in several of the agencies of the Department will illustrate the ways in which the Department, and the Federal government, has benefitted from the advice and assistance of the many highly qualified individuals who have served under consultant appointments. National Institutes of Health The use of consultant services is considered central to the continuing advancement of the national and international biomedical research and communication mission of the NIH. One of the primary purposes of utilizing the consultant appointment mechanism is to assure the essential flow of scientific knowledge and expertise from virtually every segment of the scientific community in order to enhance the pursuance of the most fruitful courses of research investigation. Among the many contributions made by consultants at NIH are the following: a. A consultant to the National Institute of Arthritis, Metabolism, and Digestive Diseases has provided recommendations on research programs of burn shock therapy which have enormous clinical implications for the treatment of severely burned patients. Also, as an international authority in the field of traumatic shock his advice and suggestions have lead to the development of the majority of techniques now used in research studies conducted within this Institute. b. An internationally renowned diabetologist, serving in a consultant appointment, has contributed valuable advice on productive research studies in the field of vascular disease and its relationship to diabetes. A further result of his advisory contributions has made possible one of the major NIH research efforts in the study of diabetes. c. A National Cancer Institute consultant assisted in the establishment of protocols for the clinical trails of new anti-neoplastic agents which have contributed greatly to the improvement in remission and curatives in childhood leukemia. d. Another outstanding scientist provided consultative advice and guidance that has helped chart the course for modern chemotherapy. His basic observations in animal tumor models, and their relationship to the human situation, form the basis for much of the work in this field that is being done today. Office of Education a. Use of consultant services by the Task Force on School Finance resulted in the compilation of a report concerning national issues and recommendations evolving from forums concerning the Federal role in School Finance. This report has been useful for more effective service by the programs of the Office and for serving as a basis for revision of existing programs. b. The Office of Equal Employment Opportunity utilized the services of a consultant to develop an EEO information and communication plan which has resulted in the implementation of a more responsive and accurate reporting and information system and can be used as a basis for identification of specific areas of EEO in which improvements are needed. c. The Teacher Corps used consultant services to obtain advice on the development of a management by objective system. As a result, all branches in the Teacher Corps have developed task oriented goals and a reporting system for assessment and feedback to management on the results obtained. d. Consultants utilized by the Accreditation and Institutional Eligibility Staff of the Bureau of Higher Education have provided reports to the Advisory Committee regarding institutional and specialized accreditation; the Commissioner's criteria for recognizing private, voluntary accrediting agencies and State agencies; and specialized areas in education such as clinical pastoral education. In addition, consultants have provided special investigative reports on numerous areas, such as correspondence degree programs, to clarify policy issues under review by the Advisory Committee. More generally, consultants facilitate the decision-making process of the Advisory Committee by providing expertise during Committee deliberations on issues and problems in areas which fall outside the more general areas of specialization of the Staff and the Committee. These services insure that the Commissioner will be fully apprised of all issues, and the scope of such issues, necessary for his determinations relating to recognition of accrediting bodies, and to the development of policies in the area of institutional eligibility for funding. Food and Drug Administration FDA's use of experts and consultants is essential because of the broad and diverse professional and scientific activities reflected in the agency's programs. Because of the range of knowledge and expertise required to assure that the actions and decisions of the agency are based on the best available scientific advice, the consultant services of individuals specialized in particular disciplines are often required to supplement the regular staff. Typical of the services rendered by FDA consultants are the following: a. One of the nation's foremost authorities on lipid and amino acid metabolism was appointed in the Bureau of Foods to perform periodic reviews and advise on projects in the Biochemical Toxicology Branch involving lipid, protein, and amino acid metabolism. Among significant accomplishments was his advice on the protocol for a project in which the artherosclerosis problem involved the study of pigs on a defined semi-synthetic diet. His knowledge of a yet unpublished similar study in Europe resulted in an improved FDA protocol negating planned preliminary studies and saving the agency both money and valuable scientific time. b. An authority in mathematical statistics was appointed in Bureau of Foods to provide needed expertise in his specialty, i.e., mathematical model building, in the development of methodology for estimating toxicologically safe dose levels and design analysis of acute and chronic studies of toxicity, mutagenicity, teratogenicity, and caracinogenicity. On the basis of his comprehensive knowledge of several mathematical models and procedures for assessing the degree of risk to humans from food additives or contaminants using animal experiment data, the consultant developed a generalized mathematical model encompassing these various existing techniques. This model permits the definition of animal experiments corresponding to different toxicological responses, degrees of risk and form of dose/response relationship. Thus, experimental conditions may be more accurately defined and more quickly derived. The generalized model also permits the ready identification of those factors which are of critical importance in each application. C. FDA has underway the comprehensive review of all OTC (over-the-counter) drugs by panels of experts for safety and efficacy. This review was mandated under the 1962 Drug Amendments to the Federal Food, Drug, and Cosmetic Act. FDA's approach calls for the classification of OTC drug products by their therapeutic categories and the submission of data by the drug industry relating to the safety and efficacy of such marketed OTC drug products. FDA's panels of experts review the data with a view to the publication of monographs in the form of agency regulations. These regulations will form the basis of a consistent system for the regulation of the OTC drug market in the interests of the public. There are some 26 drug categories being studied by 17 panels. Ultimately more than 200,000 nonprescription drugs will be affected by their work. Typical of the 17 panels is the OTC Panel on Review of Antimicrobial Agents. The critical assistance given by the panel in identifying the hazards of hexachlorophene enabled the FDA to establish regulations providing for the effective control of the levels of hexachlorophene and other antibacterial ingredients in drug and cosmetic products for repeated daily human use. Health Services and Mental Health Administration Consultants employed during the first half of 1973 by the Health Services and Mental Health Administration provided consultation services to the Administration's sixteen national health programs. These consultants have provided a wide range of highly technical and specialized advice regarding such health concerns as: the effects of pesticides exposure; the transition of comprehensive health planning activities from urban to rural areas; infant and child nutrition; the establishment of sickle cell disease programs; the utilization of professional optometrists to provide eye care to the Indian population; the design of Occupational alcoholism programs; and the statistical and research methodology to be used in the field of drug abuse. Specific examples of the results of consultant services include the following: a. The chapter on diseases of the musculoskeletal system in the International Classification of Diseases is generally considered inadequate. The National Center for Health Statistics appointed an orthopedic surgeon and a medical record librarian as consultants to prepare an improved version of this chapter as well as modifications of categories of congenital malformations and injuries of bones, joints, and muscles. This material was used in the U.S. proposals to the World Health Organization for the Ninth Revision of the International Classification of Diseases. b. A consultant was appointed in the Division of Narcotics Addiction and Drug Abuse to provide consultation in the area of systems analysis embodying methodologies related to linear programming, regression analysis, and operational analysis. His consultation has provided the Division with a greater capability to solve problems related to the cost of patient treatment as a function of treatment modality and program source. Other Examples The Social and Rehabilitation Service has utilized the services of two consultants with extensive knowledge of State Medical operations and with experience in designing and operating utilization review projects to advise on the development of plans for implementing the utilization review requirements mandated by Public Law 92-603. A consultant specialized in the field of educational psychology has provided valuable assistance on issues relating to elementary and secondary education. His particular contribution was to analyze justifications for ability groupings of students applying for Emergency School Financial Assistance funds and advise the Office for Civil Rights concerning the validity of such justifications. EXTRACT OF MIKE CAUSEY COLUMN ON CONSULTANT PROGRAM PENSION Senator FONG. We have here the column by Mike Causey, Washington Post, July 3, 1973, talking about the consultant program revision ahead: The use and abuse of consultants is one of the gray areas of Federal operations because nobody knows for sure how many outside experts Uncle Sam hires, how much they get or what they are consulted about. CSC's plan requires that each new appointment-or extension of a consultant-must be reviewed and certified by a top official of the employing agency. Health, Education, and Welfare, one of the major users of consultants, has been accused of hiring consultants who recommended, in turn, that more consulting work be given out to their own firms. The list goes on, hence the new plan. Mr. CARLUCCI. Mr. Chairman, I know of no case where there has been that kind of conflict of interest. I would be glad to look into the specifics. I don't always agree with Mr. Causey. Senator FONG. I agree with you on that. OVERUSE OF CONSULTANTS Mr. CARLUCCI. But I must say that both the Secretary and I are convinced that we have overuse of consultants at HEW, and this is the reason we have directed an intensive review of consultants and have instructed the agency heads to cut down on the use of consultants. Senator FONG. And you are in the process of doing that? Mr. CARLUCCI. We are in the process of doing that, and I would be glad to provide the Secretary's memo for the record and the specifics on that. Senator FONG. Fine. [The information follows:] TO DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE MEMORANDUM Assistant Secretary Agency Heads Heads of OS Staff Offices Regional Directors I am concerned about the large number of consultants who serve in an individual capacity to provide advice and assistance to HEW program managers. While the service rendered by many of these individuals is essential for effective management of Department operations, I am convinced that the number of consultants is excessive to our needs. I am asking, therefore, that you review the appointments of on your rolls. This action should include terminating or not to In addition, I am asking that you provide for an appropriate review of proposals to make new appointments, or to renew existing ones, ensure that these appointments are made only when the needs of your programs cannot be met without such consultative advice and assistance. Instructions for the review of the use of consultants are outlined in Your personal attention to this review effort will be necessary to accomplish its objectives, and I expect you to structure the review in your organization in such a way that you are personally involved. Attachment A |