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The Commission on Narcotic Drugs of the Economic and Social Council of the United Nations considered this problem in its 13th session (April 28-May 30, 1958) in Geneva.

In connection with khat, some countries believe that the fact that excessive consumption of khat leaves is harmful does not by itself justify restrictive action. Diverse substances such as alcohol, tobacco, and other items are certainly harmful if taken immoderately, but no international control is considered necessary in these cases. Opinion holds that it will have to be found that the danger of the leaves is, very great, similar to that of narcotic drugs, before international action proves warranted. Moreover, the economic and social difficulties which might be created in some regions by the prohibition of the cultivation of the plant cannot be overlooked.

In view of the critical importance of the question of addiction, WHO was asked to sponsor à scientific investigation of the medical aspects of the habitual chewing of khat leaves. Since this entailed the determination of the active principle(s) of these leaves, the Organization arranged for a collection of khat leaves from different regions to be analyzed at the Pharmaceutical Institute of the University of Bonn, where chemical research on the khat alkaloids was already underway. After more than a year's work this institute succeeded in isolating an alkaloid which is distinct from d-nor-pseudo-ephedrine, up to then generally accepted as the active principle involved. The Institute expects to isolate three more alkaloids and the pharmacological and toxicological properties of all of them will be studied.

3. PHARMACEUTICAL PREPARATIONS AND BIOLOGICAL STANDARDIZATION 5

The establishment of specifications for the quality examination of pharmaceutical preparations has involved research regarding methods to recognize and define the quality of medicinal substances, their purity and activity, freedom from abnormal toxicity, potency, melting temperatures, etc. This research has been partly carried out by members of the Expert Advisory Panel on the International Pharmacopeia and Pharmaceutical Preparations, but other specialists in different countries have also taken a substantial part. All this work has been done with little financial assistance from WHO.

During the last 10 years the Danish Statens Serum Institute and the National Institute for Medical Research in London, have, with some financial support from WHO, engaged in several collaborative biometrical studies in which many laboratories in different countries also took part. These studies involved research into

(a) a suitable method for measuring the antibiotic content in antibiotic preparations and in blood serum;

(b) reference preparations for measuring the serum content of antibodies against poliomyelitis;

(c) the stability of biological preparations at high temperatures; (d) an international standard for anti-yellow-fever serum (a study supported by WHO through grants to the West African Council for Medical Research Laboratories, Virus Research Unit, Lagos).

See pt. V, sec. E(1) as regards relationships with U.S. pharmaceutical companies.

4. CHRONIC DISEASES OF MAJOR SIGNIFICANCE IN THE UNITED STATES

With respect to both cancer and heart disease, a major barrier to research on an international basis has been the inability of scientists to compare results obtained in different countries. Diagnostic criteria differ among investigators. Definitions of terms are not uniform. (a) Cancer

When, as in the case of cancer, there are some 40 major subdivisions of the disease, a tremendous task of definition and classification must precede many kinds of international studies. In an effort to deal with this problem, the World Health Organization set up a lung tumor center under the guidance of Prof. Leiv Kreyberg, at the Rikshospitalet in Oslo, Norway, a distinguished scientist with whom I had the pleasure of conferring.

WHO, moreover, has plans-whose execution will depend on the availability of funds to establish comparable centers for all major types of cancer. The importance of prompt availability of such funds can hardly be overemphasized.

To carry cancer research forward, the World Health Organization invited the International Union Against Cancer to serve as the agent of cancer investigators throughout the world in drafting an international cancer research program. It then called together in Geneva, three world-known experts to assist in the development of a cancer research program requiring international collaboration. The scientists participating in this effort were:

1. Dr. Leiv Kreyberg, professor of pathology, Rikshospitalet, Oslo, Norway.

2. Dr. Harold L. Stewart, chief of the laboratory of pathology, National Cancer Institute, president of the American Association for Cancer Research.

3. Dr. Morton Levin, assistant commissioner for medical services, New York Department of Health.

(b) Cardiovascular ailments

Dr. C. J. ván Slyke, Associate Director of the National Institutes of Health, has written:

In recent years, heart disease has been appearing as the cause of death on the death certificate with greater and greater frequency.

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Heart disease today knows no international boundaries. However, for all its magnitude and scope, it suffers from a lack of worldwide investigation.

Surveys both here and abroad are slowly accumulating information, but this is a slow process. Also, lack of comparability of data often makes meaningful interpretations impossible. We need well-organized studies that can collect clinical and pathologic information on heart disease over several years, not just from hospital clinics and private practice but from entire communities. By these means we can learn more about host and environmental factors related to hypertension, rheumatic fever, and coronary heart disease. Challenge and hope lie in the simple fact that the morbidity and mortality from heart disease differ with populations and countries. What we learn about the Bantu, the Japanese, and the Italians becomes a challenge to us in the United States and in northern Europe.

Present knowledge of heart disease incidence and mortality in different populations and population segments is rudimentary. We look for some of the answers in vital statistics, but much of the desired data is missing or incomplete and what is available must be carefully analyzed. Wartime experience of the • The Journal Lancet, Minneapolis, June 1958, vol. 78, No. 6.

Scandinavian countries has demonstrated quite clearly that the problems of arteriosclerotic heart disease in a given population can change in as short a time as a year or two.

International action has begun on world public health problems involving heart disease. Members of groups such as the International Society of Cardiol ogy, the International Congress of Internal Medicine, and the World Health Organization have been attempting to meet the universal heart disease problem since World War II.

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WHO might suitably assist in planning and coordinating the development of certain international research efforts which it would be uniquely qualified to foster. Group support for a program such as this would return ultimately to each member nation a positive dividend in the form of improved national health. This is true just as surely as the present interchange of scientists, limited though it is, mutually increases national research skills.

Thus, we observe that the same problem of establishing the necessary degree of agreement on terms, classification of disease states and the degree of advancement of disease as a prerequisite to a research program, has existed in the field of heart disease. In collaboration with the National Heart Institute of the U.S. Public Health Service, WHO in the latter part of 1957 convened a study group on classification of atherosclerotic lesions. The study group first defined atherosclerosis and other pathological terms commonly used to describe lesions observed post mortem. It then discussed the classification and grading of atherosclerotic lesions and made a series of recommendations on uniform objective methods for making and recording observations. These technical discussions were put in book form for the information of scientists throughout the world.

While work on the problem of classification and standardization was going forward, possible lines of research in the cardiovascular field were explored by highly competent scientific groups advisory to WHO. As early as 1954, at the meeting of the Joint FAO/WHO Expert Committee, a recommendation was made that consideration should be given to relationships between diet and health, especially in the more highly developed countries and in certain segments of the population in many other countries.

The Committee suggested for particular study the problem of degenerative heart diseases, including coronary heart disease, angina pectoris, and myocardial degeneration, since there is evidence that habitual diet plays an important part in the development of these conditions. In 1955, a study group considered the geographical pathology of atherosclerosis. It suggested that the apparently marked differences between different countries in mortality statistics of cardiovascular disease-and particularly of atherosclerotic and degenerative heart disease-should be carefully examined in comparative studies, which should be extended to autopsy findings where the differences are very marked. The difficulty of correlating clinical diagnosis and autopsy findings was pointed out. The importance of the worldwide coordination of studies by the development of reference laboratories or centers was also stressed.

The pattern

We see then the pattern of development of WHO research activities relating to heart disease, cancer, and other important chronic diseases. First, the necessary steps to clarify definitions and classification have been taken. Second, expert groups have proposed programs of productive, feasible research. The latter step has occurred well before

the member nations have seen fit to provide the necessary financial and other backing to carry out the research.

Given the background of initiative for international research arising strongly from qualified scientists, and a background of meager support for WHO research programs in the chronic diseases by member nations, the future of WHO medical research becomes a pertinent subject for examination.

F. THE FUTURE OF INTERNATIONAL MEDICAL RESEARCH AND WHO

From the committee print entitled "International Medical Research," it is clear that medical research has always been an international undertaking, and that increasing international cooperation is required if medical research is to be most fruitful in the future.

This part has shown that WHO has administered an extensive medical research program, albeit principally in connection with the control of infectious diseases. It has pioneered in the practical problems of planning worldwide research efforts. It has built a fund of good will and is accepted throughout the modern scientific world as a neutral sponsor of research. It has built research on an international basis soundly, and research has gradually evolved from its operating responsibilities.

1958 amendment to Mutual Security Act

Such considerations led me to study legislation relating to the role. of the United States in international medical research, particularly through participation of this country in research planned and coordinated on an international basis by WHO.

At this point, I should like to cite an amendment which I had drafted and which had been approved by the Congress in June 1958. This amendment added to the 1948 act which had authorized U.S. participation in the World Health Organization the following language:

SEC. 6. The Congress of the United States, recognizing that the diseases of mankind, because of their widespread prevalence, debilitating effects, and heavy toll in human life, constitute a major deterrent to the efforts of many peoples to develop their economic resources and productive capacities, and to improve their living conditions, declares it to be the policy of the United States to continue and strengthen mutual efforts among the nations for research against diseases such as heart disease and cancer. In furtherance of this policy, the Congress invites the World Health Organization to initiate studies looking toward the strengthening of research and related programs against these and other diseases common to mankind or unique to individual regions of the globe.

U.S. initiative at Minneapolis assembly

Such considerations also led the United States to make certain suggestions in 1958 in the 10th Anniversary Commemorative Session of the World Health Assembly in Minneapolis, Minn., which I had the pleasure of attending. We suggested that the WHO might make an intensive examination of its role in medical and health research, as well as world needs and opportunities for expanded research. It would do so with a view to the presentation to the 12th World Health Assembly, of a carefully conceived and well-designed plan to provide increased WHO leadership in this field.

Account was taken, in suggesting the study, of the need for more intensive research in relation to problems encountered in campaigns against diseases for which there are effective control measures, such

as malaria, and particularly of the urgent need for expanded research in relation to other diseases and public health problems, especially in the field of chronic illnesses such as cancer and heart disease.

The suggestion was made in the hope that through the proposed study WHO would find the way to make its greatest contribution to the further development of the total world research potential in medicine and health.

Types of WHO research activity

It was further suggested that WHO could quite well expand its role in research, with great effect, in the following areas of activity, among others:

1. Coordination of research on an international scale through integrated laboratory networks;

2. The identification and definition of gap areas in medical and public health research;

3. Standardization of scientific terminology and methods;

4. Facilitation of communication between scientists and research institutions;

5. Determination of unmet requirements for facilities and equipment;

6. Training of research personnel;

7. Promotion and support of scientific congresses, seminars, and other meetings of medical scientists;

8. Stimulation and advice to national and international official and voluntary agencies in the research area.

The United States wisely recognized that an intensive study by WHO might lead to the development of a plan for an expanded WHO role in the furtherance of research that would commend itself to member states. Our country made therefore, as previously noted, a special grant of $300,000 to WHO to enable it to conduct such a study. At the same time, the working paper relating to medical research, as submitted by the U.S. delegation noted that

It is the present intent of the U.S. Government to provide substantial support to any sound program that may emerge from the proposed study, subject to participation by a number of other member states.

In studying the progress of research planning by WHO in Geneva, I was particularly impressed, as noted below in part 5-A, with the fact that some of the best scientists and statesmen of science in the world have been willing to help WHO plan its expanded research program. With such talent at its command, the plans that are developed should prove as sound as they can be made by the mind of

man.

The vast challenge: Old and new dilemmas

The challenge is great. Old disease dilemmas and new ones confront mankind.

In the former category, it is essential that American know-how, achieved through the relative subduing of communicable and infectious diseases in our own land, should be made increasingly available to the world. Experiences, for example, of our Communicable Disease Center in Atlanta can hardly be overestimated in their value to a world still largely beset by communicable scourges.

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