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FOA/Washington Tousfe A-555

The following information concerns the hexylresorcinol on
hand at this Mission. The entire lot was supplied by the Retort
Pharmaceutical Co., Inc., Long Island City, New York.

There is considerable information in the files of FOA/W
concerning tests of samples of this drug made by the Food and
Drug Administration, New York Laboratory - reference Mr. Ningher's
letter dated 15 July 1953.

Concerning the coating on the pills, in no instance does it
resemble a tough rubber coating but seems to be more of a brown,
rather brittle, type of coating. The following is an inventory
and also numbers concerning the three lots on hand.

Arrived

Contract GS-00P-16154 PR 95-370-00-H201-2229.
July 22, 1952. This entire lot is unsatisfactory because of the
fact that the coating has cracked and is disintegrating. There
are on hand 1,073,119 vials of 5 tablets each.

Second lot. Contract GS-00P-16436 PR 95-370-00-202-2273.
Arrived September 12, 1952. The coating has not yet cracked but
does not have a feeling of toughness but seems rather brittle.
It can be used for adults with some safety. However, it will have
to be closely supervised when used for children. On hand 697,184
vials of 5 tablots each.

Contract GS-00P-16436 PR 95-370-00-202-2273. Arrived

4 October 1952. Again the coating on this lot is brittle but is
holding together. It can be used for adnite but must be closely
supervised when used for treating children. On hand 702,814
vials of 5 tablets cache

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Mr. BROWNSON. Then, in a routing slip, which is attached to this, I would also like to include-this is a General Service routing slipin which some inquiry was made as to the disposition of the case. It is sent in this particular instance to Mr. C. Wolfe, room 5258, and it is marked for necessary action; the file reference number is indicated, and the following notations are made:

(1) Retort-replace?

(2) Legal claim?
(3) Reprocessing?

(4) Destroy this?
(5)

and there is just a question mark.

Apparently, Doctor, you and Dr. Raffety had a difference then of medical opinion as to the administration of these hexylresorcinol pills; is that right?

Dr. ROBBINS. That is correct. However, I might point out that I had a physician on my staff, Dr. Thorngate, who had been a medical missionary in China for 20 years, and who was responsible for the hospital program and the first aid, or rural dispensary program, and we had other people on the staff (about 15 public-health trained workers) who participated in our discussions. So, it was not my opinion alone. It was a joint decision made after a 7 months' study. Mr. BROWNSON. I am only sorry that our expert in missionary medicine, Dr. Judd, who is a member of the subcommittee, cannot be with us this morning. I would like to get his reaction on that, because he, of course, had many years experience in the medical missionary field in China.

Dr. ROBBINS. That is right.

Mr. BROWNSON. With this difference of opinion between you, as supported by your staff members, and Dr. Raffety, I am a little surprised that there was not any discussion as to this difference of opinion in view of the enthusiasm with which the lowering of the price on hexylresorcinol was greeted, and the general feeling that this program was extremely vital.

Dr. ROBBINS. There was, at the time I was Chief of the Public Health Branch of the ADS program in TCA, Mr. Kaarlo Nasi, sanitary engineer, who was Acting Chief of the MSA program from November 1952 until FOA was organized and after that Chief of the Far East Branch of the Public Health Division, and I have heard him talk several times about this. He had been in correspondence with Dr. Raffety, but the question of diagnostic facilities did not come up really as much as other portions of the program. I think diagnostic facilities were a relatively small part in the determination. It was the quality of the capsule that I heard most of the discussion. about.

Mr. BROWNSON. Mrs. St. George? Do you have a question?

Mrs. ST. GEORGE. I would like to ask one question, Mr. Chairman: Was Dr. Raffety the only one whose opinion was against these capsules? I understand that you and your staff all felt that they were usable, and that they could be used.

Was it his opinion alone which opposed their use?

Dr. ROBBINS. The mission director, of course, is in charge, and Dr. Thorngate and I left about the same time. The rest of the staff stayed. There was a Dr. Braff who inherited the first-aid station program. I was not in on the discussion, and I do not know the reaction of Dr. Braff, or the others. So I am afraid I cannot answer that question.

Mr. BROWNSON. If I understood it, Mrs. St. George, Dr. Raffety was not opposed to the use of the capsules, but he felt that diagnoses would have to be accomplished by trained medical personnel before the pills were prescribed. There was a difference of opinion in regard to the diagnostic technique; is that not right?

Dr. ROBBINS. That is right.

Mrs. ST. GEORGE. As as result of his opinion, they were stored, and not put to general use; is that correct?

Dr. ROBBINS. I have a feeling that the quality of the capsule influenced the decision.

Mrs. ST. GEORGE. His decision, yes; but what I mean is that his decision was the paramount reason why this original quantity was put in storage, and never used?

Dr. ROBBINS. That is right.

Mrs. ST. GEORGE. What I was trying to find out, Mr. Chairman, was whether it was just one man's opinion, or whether it was a thing that had been arrived at after considerable discussion among the various experts.

Mr. BROWNSON. Was this decision ever taken up in Washington, or do you know?

Dr. ROBBINS. It was, but as I said, the only discussion that I know of in Washington hinged around the capsule itself, and not on the question as to whether it should be dispensed by first-aiders.

There had not been any question in the mind of the-there had not. been any questioning of that except in the advisability of the hexylresorcinol as a public-health program. If it had not been Indochina and the war had not been going on and if we had not been at the time having military reverses, we might not have gone into such a terrible expensive program as hexylresorcinol. Actually, I would prefer to attack the round worm problem by good sanitation—that is, by installing pit-type toilets. But that was the long-range program, and we would not have gotten results from that because of the difficulties of education in personal habits. We would not have gotten results for 5 or 10 years. We wanted an immediate impact and that is why the hexylresorcinol was used.

Mr. BROWNSON. Some of these pills were administered while you were there; were they not?

Dr. ROBBINS. They arrived July 22, and we were in the process of making farewell visits and, so far as I know, it takes a whole lot of time for them to go through customs, and it takes a while for them to be warehoused, and to be sent out.

I do not remember that any of them were used while I was there. Mr. BROWNSON. Do you have any questions, Mr. Ikard?

Mr. IKARD. I have no questions.

Mr. BROWNSON. Mr. Holtzman?

Mr. HOLTZMAN. The nub of the entire problem here was not whether there should be a proper diagnosis or whether it should be administered under substantial medical supervision, but the nub of this whole problem was the quality of the drug; is that not so?

Dr. ROBBINS. That is right.

Mr. HOLTZMAN. So, there was never any difference with respect to the general administering of this particular medicine; was there? Dr. ROBBINS. No.

Mr. HOLTZMAN. It was always the nature and the quality of the drug and the coating itself; is that right?

Dr. ROBBINS. Well, the nature of administering it, I might interpret that in the light of Dr. Raffety's one letter. This is the only letter that I know of where he stated his reason for not using them, was lack of diagnostic facilities, but his point was that it was safe in the hands of a physician, or it is effective in the hands of a physician, because he can look under a microscope, or have laboratory people to do it,

55430-54- 2

and that it was not effective in the villages because in the village your first-aider does not have a microscope, and does not have anything to examine it with.

One more thing, and I think it is very interesting: We found about 80 percent of these people had one type worm, or several, and we had discussed the possibility of withdrawing that qualification of finding worms of the stool. We might almost as effectively have said, "Give it to all the children."

Mr. HOLTZMAN. No further questions.

Mr. BROWNSON. Mr. Williams?

Mr. WILLIAMS. Mr. Chairman, these pills were supplied under two contracts; were they not?

Mr. BROWNSON. Yes; that is right.

Mr. WILLIAMS. And both contracts which we have now in the record of this hearing called for a tough gelatine coating; is that right? Dr. ROBBINS. Yes, sir.

Mr. WILLIAMS. The contract also provided ample opportunity to the Government to inspect these pills, and reject them if they did not meet the qualifications of the contract; is that right?

Dr. ROBBINS. Yes, sir.

Mr. WILLIAMS. It also provides-both contracts provide that if they are rejected and if they are rejected from the point of manufacture, the company which manufactures them even has to pay the cost of bringing them back?

Dr. ROBBINS. I do not know about that, because I am not familiar with it.

Mr. WILLIAMS. Well, I think the contracts show that, and that they will speak for themselves.

Be that as it may, it was known at least in the field after these pills arrived that this was not a tough gelatin coating?

Dr. ROBBINS. That is right.

Mr. WILLIAMS. The coating was described as brittle?

Dr. ROBBINS. That is right.

Mr. WILLIAMS. In other words, the contract was not fulfilled in that respect?

Dr. ROBBINS. That is right.

Mr. WILLIAMS. Whose decision would it have been to reject these pills in the field, with the view of either getting replacements, or getting a credit on the contract, or paying nothing on the contract? So whose decision would that have been, out there?

Dr. ROBBINS. Maybe I had better say that it would have to be a joint decision, perhaps, between the Public Health Chief and the mission. Mr. HOLTZMAN. Suppose you give us the names of these people, as you go along.

Dr. ROBBINS. It would have been the responsibility of Dr. Raffety as Public Health Chief or Mr. Curt Faulk, who was procurement officer of the mission director, who is Mr. Frank Bartlett, and all the procurement people here, as well as Mr. Hingher, and Mr. Massey, who was at that time Chief of the Public Health Program, MSA.

Mr. HOLTZMAN. There just was no chance that these pills could be widely used; that they had to be closely administered by a physician? Dr. ROBBINS. That is right; if you would interpret that they were not safe to give to children, under the supervision of the first-aider. That is the only thing.

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