Infectious Diseases and the Division of Research Grants. Both of these programl provide a considerable amount of the know-how and trained people essential to als the other Institute programs. If the total research effort in the medical sciences is not to become distorted far out of balance it is essential that each of these programs receive substantial increases above the budget estimate.

Dr. MCDERMOTT. I am here to make a plea for several items in the Public Health Service budget. The first is the Division of Indian Health, and the $5 million increase above the budget estimate as recommended by the directors of the National Tuberculosis Association. Although I happen to do my research and teaching in midManhattan, I also operate a project out in the middle of the Navaho Reservation, so that every 5 or 6 weeks all year long I am right out in the very midst of the wildest part of Indian country and intimately engaged in the health question there. So that, from that standpoint, I have an opportunity to see what the Public Health Service is doing or is not doing in these areas.

It is my considered opinion that they are doing an excellent job, but that they need considerably more help; they particularly need help in program. They also badly need construction. When one hears of lack of housing, it is not inadequate housing, Mr. Chairman; it is no housing in the middle of a prairie, no housing for public-health nurse or physician. I strongly endorse the increase of $5 million above the budget estimate for this program. This is a national program, a national problem which happens to be regionally situated and, hence, is a difficult one for many of us to know about.

The other 2 items to which I would like to speak have to do with 2 programs of the National Institutes of Health. One is an area known as the Division of Research Grants, which is in the item in the budget under "General research and services." This is a relatively little-know area of the grants program of the National Institutes of Health, but one of the most important areas. I have an intimate knowledge of this program because the National Advisory Health Council is the Council for the research conducted in these areas. These represent the research projects which are at the beginnings of fields before institutes get established, before an area becomes categorized enough to justify its existence as an institute.

For example, the research in the automotive fatalities on our highways came from this program. Research in public health comes in this program; research in bringing physics and mathematics to the problems of the study of medicine comes out of this program. But, because it has no institute label, it is a program which many people do not know about, and yet it is a program which forms the underpinning for many of the other programs. They badly need money, they need much more money than is in the budget estimate. Indeed, a sum of $10 million more than the budget estimate would be a reasonable sum for this program to carry on in the next year.

The other item in which I am especially interested is the National Institute for Allergy and Infectious Diseases. I have been appearing in behalf of this Institute, as the chairman knows, for the last few years. Up until 3 years ago, this Institute program was very inadequately supported, but has received substantial increases in recent years. Despite that fact, however, they are way behind in terms of a balanced program and need far more money to carry on the program commensurate with the needs in this field of infection and allergy

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which, when taken together, is one of the major public-health areas in this country.

They should have, in my opinion, an addition above the budget estimate of $5 million and, in addition to that, should have another $1,600,000 for an adequate traineeship program. What could they do if they had this money? One area in which they have a small program going, but in which a much expanded effort could be made, would be in the total field of vaccination against tuberculosis and some of the other common bacterial diseases which are now becoming problems in our areas. One of these is the infection caused by staphylococci which haunt our hospitals and are responsible for deaths and illnesses in the very patients whose lives have been saved by advances made in the field of treatment of heart disease, cancer, arthritis, and other such things.

In tuberculosis, we have a steadily increasing need for vaccine and we need a vaccine far better than BCG, the only available vaccine. Money could be very well spent in all of the fundamental aspects of learning the hows and whys of this vaccine business so that a vaccine could be worked out which would be fitted into a total program in TB. To give you some idea of where money is needed in a tuberculosis vaccine study, Dr. Rene J. Dubos and I are jointly engaged in a project on a vaccine which he has developed. He has all the resources of the Rockefeller Institute laboratories in TB at his command, and I have the comparable resources at the New York Hospital-Cornell, right across the street. Yet we are at a stage where we happen to want to try this vaccine on 100 tuberculous guinea pigs. In order to set up these experiments, we have to set them up in Hamilton, Mont., even though our experiments are being conducted from New York City. Research facilities in the tuberculosis and infectious disease field are badly needed.

I can summarize my position by saying I would strongly support 3 substantial increases above the budget estimate; 1 of $5 million in the Indian health program, 1 of $10 million in the general research and services program, and 2, 1 of $5 million and a traineeship program of $1,600,000, for the National Institute of Allergy and Infectious Diseases.

Mr. FOGARTY. The ideal thing would be to develop a vaccine that would prevent tuberculosis.

Dr. MCDERMOTT. That is right.

Mr. FOGARTY. Is that what you and Dr. Dubos are doing?

Dr. MCDERMOTT. Yes, and some 4 or 5 other groups are engaged in that.

Mr. FOGARTY. How long will it take to develop such vaccines? Dr. MCDERMOTT. It is hard to say, but progress is being made. I think it should be no further than 2 or 3 years.

Mr. FOGARTY. How long have you been working on it?
Dr. MCDERMOTT. About 2 years, intensively.

Mr. FOGARTY. How many people would you think you would have to test to establish the effectiveness of the vaccine?

Dr. MCDERMOTT. I think you would have to do that in 2 stages; first, a small number of people, 25 or 100, simply to establish the fact that the vaccine could be tolerated and, perhaps, that it did not cause positive tuberculin reactions. Then, to prove the real point as to its

efficacy, I believe it would take thousands of people. By thousands, I mean 15,000, let us say, in a group.

Mr. FOGARTY. It is fair to say, then, that a vaccine for tuberculosis is not just around the corner?

Dr. MCDERMOTT. That is correct.

BCG

Mr. FOGARTY. You mentioned BCG. You are an expert on that, I have been told.

Dr. MCDERMOTT. I am familiar with it.

Mr. FOGARTY. We had a little discussion with the United States Public Health Service people on the effectiveness of BCG a couple of weeks ago and they did not seem to think that it should be used on a nationwide scale. What is your reaction?

Dr. MCDERMOTT. I would feel the same way. The problem with BCG is not scientific, there is no scientific controversy about BCG. It is wholly a question of practical wisdom, whether to use it or not. Everybody is pretty much agreed on the scientific aspects. What it comes down to is this

Mr. FOGARTY. What is that society, Trudeau Society?

Dr. MCDERMOTT. Yes. They would agree definitely to that position. In fact, they have issued statements on BCG before and are about to issue one again. Their statement and the statement of the Surgeon General's committee would be very much the same. All of these, as I say, have to do with the practical wisdom of using this material rather than the value of the material itself. What it comes down to is that BCG is a weak, short-lived vaccine but it is that. It is a vaccine with some definite effectiveness but its effects are short lived.

This is at its best. It happens to be a variable substance as it is produced in different laboratories, it comes out differently, so that it varies all the way from zero in effectiveness to a vaccine that is weak but has some effects. Unfortunately there is no way in tuberculosis to measure in a man whether an antituberculosis vaccine is producing an increase in resistance. So that the only way you can measure it is, 1, in animals, and the other is to treat 15,000 people in a very carefully controlled experiment and follow them 5 or 6 years and see what happens.

Despite all the studies and use of BCG made around the world only about six of these studies, these carefully controlled studies, have been set up around the world which are acceptable scientifically to all knowledgeable people. Everybody agrees these studies are good. They have shown this. What it amounts to is there are only about six batches of BCG that have been subjected to the final test. What they have shown is what we would have expected from the laboratory. The strongest BCG made was the one the British used in their studies and it was, as I said, a weak but definitely effective vaccine.

The weakest vaccine was one that was studied down in Muscogee County, Ga., by the Public Health Service and that particular vaccine had no effectiveness. There was no difference at all. That is the Tice strain, made out in Chicago by the Institute out there. So that one has all the way from a relatively weak vaccine to a zero vaccine.

The question that comes up is admitting this is a weak vaccine, if it is the only wheel in town, why not use it? My own position is that in certain specialized circumstances it does make sense to use it. In fact I have used it myself 3 times in the last 2 years in laboratory workers who are constantly exposed to tuberculosis. Where the rub is is the fact that because it is a weak vaccine and a short-lived vaccine at best, when it is really standardized well, the time to give it is just before or soon before or within 6 months or a year of the time the person is going to have his maximal exposure to tuberculosis. In a laboratory worker you can predict that. In a nurse in a tuberculosis ward you can predict that. În a worker in a mental hospital with a lot of tuberculosis you can predict that. ·

But nowadays we know in this country our children in schools and in our high schools and indeed even in our colleges are not going to be exposed the way they were when I was in high school. So that if that were all there were to it you would say give it anyway, but unfortunately, giving the vaccine spoils the best case-finding method we have. It comes down to the practical wisdom of spoiling your best casefinding method, your best way of uncovering tuberculosis, spoiling it, to give a weak vaccine at the wrong time, and by the wrong time, by 30 or 40 years.

If we can get a vaccine which does not affect our case finding program, a vaccine which can be standardized and a vaccine we can measure, then we will have something.

Mr. FOGARTY. That is contrary to what the British think, on the basis of their experiment, is that right? They said this is about 80 percent effective.

Dr. MCDERMOTT. It made practical wisdom for the British at that time. At the time the British vaccinated that high school group in England, 55 percent of their high school students on graduation were infected with tubercle bacilli, had positive reactions. Today in the worse areas of Harlem in New York City or in the three really urban counties of New York City, our high school graduates only average 9 or 10 percent tuberculin positive. So that the British had a far more serious tuberculosis problem. Their children were really suffering exposure at that time far more than the children that Dr. Stocklen will tell you in the worst slum areas of Cleveland or Harlem.

Mr. FOGARTY. How about the children on some of the Indian reservations?

Dr. MCDERMOTT. There it conceivably could make sense on some of the Indian reservations.

Mr. FOGARTY. BCG?

Dr. MCDERMOTT. A good BCG could make sense. The only problem there is the complete reverse of the situation in the rest of the world. The Indian reservation probably is somewhat like the problem in India. This is the trouble there. First off, you do not get the children until they get to school. Everything that is going to happen to the child has happened before he gets to school. In short, on an Indian reservation you cannot do a newborn BCG vaccine program because half your newborn are not born in hospitals, you do not know they are born at the time. Perhaps less than half. So you cannot get your newborn program. I would not be opposed to one if you could but you cannot do it.

Mr. FOGARTY. You mean it is impossible to set up such a program among the Indians?

Dr. MCDERMOTT. Among some tribes, among the Navaho, which is the largest tribe, it would be impossible at this time. In some of the pueblos it would be possible but there the problem is not so great.

The other thing is by the time the children get to school a third of them are already tuberculin positive and are not eligible for BCG and they are the ones, the third already infected by the time they hit the first grade, they are the ones from whom the tuberculosis in the next 5 or 10 years will come.

Mr. FOGARTY. There is no way they could get that vaccine before they reach school age?

Dr. MCDERMOTT. Not in the Navaho Reservation at the present time. Five years from now with an adequate field health program going it might be possible but not at the present time. The knowledge that these births occur is not known to the authorities. These births occur out in remote canyons.

Mr. FOGARTY. Is Great Britain still carrying on this program? Dr. MCDERMOTT. I believe they are. The Scandinavian countries have just about abandoned it. Those were the countries where BCG had its strongest proponents originally.

Mr. FOGARTY. Why would Great Britain be carrying on these demonstrations if it was not practical?

Dr. MCDERMOTT. Because of the fact that their incidence of tuberculosis in their teen-age children was so much higher than ours. If ours was that high, say 55 percent of our high-school graduates, I would favor a program here, not with the present BCG vaccine but I would favor a crash program to get the present BCG vaccine in shape to use but that is not the case.

Mr. FOGARTY. Is there any way of doing further research on the best BCG vaccine there is available to make it even better?

Mr. MCDERMOTT. Yes; there should be a great deal of work on that. Mr. FOGARTY. What is being done on that?

Dr. MCDERMOTT. There is a little work going on in this country on that but the best work is being done at the International Children's Center in Paris under UNICEF and in Japan and some in the Soviet Union. Relatively little in this country though Dr. Dubos' group is doing some. BCG certainly should be made to meet the same standards as any other vaccine which right now it does not in terms of standardization. This could be done with research.

Mr. FOGARTY. What about this figure of 80 percent I have in my

mind?

Dr. MCDERMOTT. That figure of 80 percent which is the figure given in some studies, while others will go to zero percent depending on the particular study, that figure will be a figure crudely something like this, Mr. Chairman. That out of 13,000 people if 10 got tuberculosis in a 5- or 6-year period in one group and 2 got tuberculosis in another group, that would be an 80 percent effective vaccine. That is what it means. The figure is quite misleading. It is not 80 percent effective in the sense that you can take 80 out of 100 people and protect them from tuberculosis which is what 80 percent means to me. Mr. FOGARTY. Can you do that as far as smallpox and diphtheria are concerned?

Dr. MCDERMOTT. Yes.