sules for the treatment of about 300 people in each village during a year. Mr. BROWNSON. The FOA mission in Indochina, in January 1951, decided, as you said, on an impact program to establish 5,000 rural dispensaries throughout Indochina which were to be supplied with pharmaceuticals and medicines by FOA, under the supervision of the Chief of Public Health of the Indochina mission. Dr. ROBBINS. Yes, sir. Mr. BROWNSON. I understand that in August 1951, Dr. Lewis C. Robbins, the Chief of the Public Health Service, in the Indochina mission, discussed the matter in Bangkok with Mr. William Hingher, whom you have already mentioned, and the special medical consultant in FOA, Washington, who was on a field trip at the time. Out of this discussion, as you have related, came a direct decision to procure hexylresorcinol pills. When were the pills under this first contract delivered in Indochina? Dr. ROBBINS. July 1952 was the first arrival of the hexylresorcinol. That was the first order. Then, the second order-well, did you ask that question? The first arrival was July 1952. Mr. BROWNSON. Exhibit 2 shows that the second 1.5 million vials were contracted for on February 7, 1952, which was some months before the first 1.5 million had arrived in Indochina. What was the program for which the second 1.5 million pills were designated? Dr. ROBBINS. Well, we actually in the STEM mission, we actually ordered in one case a year before, but it seems to me, if I can remember correctly, the second order was requested probably in January 1952 from the STEM mission. Have I answered your question fully? Mr. BROWNSON. Yes, sir; I understand that the second order may have been procured in order to supply hospitals, in addition to these first-aid stations; is that correct? Dr. ROBBINS. That is right, but also there were funds available. We did not expect hexylresorcinol to deteriorate, and we also counted on helping out with our second year of operations with the first-aid stations. That was an additional reason, besides hospital use. Mr. BROWNSON. So, even though the first order had not yet arrived and actually been used, you felt that you could devise a program which would use the additional quantity in the second order without any difficulty? Dr. ROBBINS. That is correct. Mr. BROWNSON. You were still employed in your official capacity in July 1952, when the first shipment of hexylresorcinol did arrive in Saigon ? Dr. ROBBINS. That is right. Mr. BROWNSON. You were relieved, I understand, shortly thereafter? Dr. ROBBINS. On September 1; yes, sir.. Mr. BROWNSON. To your knowledge, were these hexylresorcinol vials actually in the rural dispensary kits as originally planned? Dr. ROBBINS. To my knowledge, they were not; neither while I was there, nor later. Mr. BROWNSON. Do you have any knowledge at all as to whether the hexylresorcinol was actually used for any purpose whatsoever? 1 Dr. ROBBINS. Yes; it has been used in hospitals, especially, sir. As I remember, the second batch had better coating than the first, and under careful supervision in the mission they were using it. Mr. BROWNSON. What happened to the pills that were not used in the hospitals? Dr. ROBBINS. Well, I am not sure I can tell you about that, sir. Your question was "How were they used in the hospital?" Mr. BROWNSON. You said some of them were used in the hospitals. Dr. ROBBINS. Yes; that is right. Mr. BROWNSON. They were originally ordered over there to be put in the rural dispensary kits, and you testified that none of them were actually included in the rural dispensary kits. Dr. ROBBINS. Yes, sir. Mr. BROWNSON. But some were used in the hospitals. I wonder what happened to the balance that were not used in the hospitals? Dr. ROBBINS. They stayed in the warehouse. Mr. BROWNSON. Do you have any idea as to how many were used in the hospitals? Dr. ROBBINS. I could not tell you. Mr. BROWNSON. Would it be relatively small, compared to the 1.5 million vials? Dr. ROBBINS. That is right. Mr. BROWNSON. Do you have any knowledge that these pills were unsatisfactory when they arrived over there? Dr. ROBBINS. We heard from Mr. Hingher a couple of days after the arrival of the first order to the effect that there was some question about the thickness of the capsule, and they were considered to not be so safe as had been expected to administer, and to administer the pills under supervision, carefully. We interpreted that to mean that if they were given out to a firstaid station, that the pill would be administered while the patient was right there at the station; that it would be given to the patient and he would swallow it there. Mr. BROWNSON. How many of these pills does it ordinarily take to complete the treatment of vermifuge? Dr. ROBBINS. About five pills. Mr. BROWNSON. In other words, the patient would have to visit the dispensary five times in order to complete the treatment using these pills with the thin coating? Dr. ROBBINS. That is right. However, they were right there in the village. Mr. BROWNSON. Was it your original plan to give the pills to the patients for them to take themselves? Dr. ROBBINS. Yes, sir; that is right. Mr. BROWNSON. In other words, the program was to administer 1 pill while the man was there, and give him the rest of the vial or the 4 remaining pills to take himself? Dr. ROBBINS. Yes, sir.. The administration can vary. You can give two pills at a time, and frankly I do not remember just the exact method of administration of these hexylresorcinol pills. They are usually given over a period of a day or two. Mr. BROWNSON. Well, if the shipments came and most of them were put in storage and were not used for the purpose for which they were intended, nor for any other purpose, then actually the matter as to whether they were satisfactory or unsatisfactory never became relevant while you were over there? Dr. ROBBINS. That is right. Mr. BROWNSON. Do you recall any conversations with your successor regarding the utilization of these pills or the problems relating thereto ? Dr. ROBBINS. We had about 4 weeks to talk about our program. The first-aid stations were uppermost in our minds at the time because they are in the process of development. They were going out rapidly. So I am morally confident we did, but I cannot remember any exact discussion. I think we just must have discussed, perhaps, briefly, the letter from Hingher about the caution regarding the administration of hexylresorcinol, but it is kind of vague. Mr. BROWNSON. Can you, Doctor, give us any reasonable explanation as to why no use was ever made of these pills, keeping in mind the ambitious program for their use which was originally initiated under your direction? Dr. ROBBINS. I think that is certainly a logical question. We were trying to work through the Government, and there were a lot of frustrations out there. When Dr. Raffety first arrived, he had a great many administrative problems and decisions to make. There was one statement from him in a letter which he sent, which I wish to bring out more about, in regard to the lack of diagnostic facilities. I think he was influenced to a great extent-to some extent or a great extent-by Mr. Hingher's letter of caution about those pills. Mr. BROWNSON. I would like to introduce into the record at this point, as exhibit 3, a letter from Dr. Raffety to Mr. Hingher and read it to the members of the subcommittee for their information. (Exhibit 3 is as follows:) EXHIBIT 3 UNITED STATES OF AMERICA SPECIAL TECHNICAL AND Mr. W. H. HINGHER, Saigon, Vietnam, August 6, 1953. Special Consultant, Medical Supplies Mutual Security Agency, Washington 25, D. C. (Through Wilbur R. McReynolds, Chief of Mission, STEM, Saigon.) DEAR MR. HINGHER: Your letter of July 21, enclosing reports from the Food and Drug Administration covering a testing of hexylresorcinol pills manufactured by the Retort Pharmaceutical Co., lot No. A2-1895, was received and noted. A copy of your attachments is appended for discussion. You will note that the one from the Retort Pharmaceutical Co. states that "this product complies with U. S. P. requirements"; but you will note that Frank H. Wiley, Chief, Department of Pharmaceutical Chemistry, states in his letter addressed to Charles R. Wolfe that the pills have a friable coating and not a tough gelatin coating as required by the U. S. P. We feel that such tablets should not be shipped into this tropical area. As you know, we have a warehouse full of these hexylresorcinol tablets that appear to be deteriorating and may be injurious to the mouths of patients when dispensed. The dispensing of these tablets has been held up because the Vietnamese, Cambodians, and Laotians lack the lab facilities and technicians to diagnosis ascariasis. Therefore, even though we have 2,000 first-aid kits dispensed in Vietnam (none as yet in Cambodia and Laos), the tablets are not being used and remain in our warehouse. If there is any other area that could use these deteriorating hexylresorcinol tablets, we would be glad to have them taken off our hands as soon as possible. In the meantime, we are trying to establish laboratory centers where diagnosis can be made in the hope that use will be made of these inferior tablets. This is for your information and any suggestions you may have. Yours very truly, (Signed) JOHN O. RAFFETY, M. D., Chief, Public Health Division, STEM, Saigon. CC: Director Programs and Operations. Mr. BROWNSON (reading): Mr. W. H. HINGHER, Special Consultant, Medical Supplies, Mutual Security Agency, (Through Wilbur R. McReynolds, Chief of Mission, STEM, Saigon.) DEAR MR. HINGHER: Your letter of July 21, including reports from the Food and Drug Administration, wishing a test of hexylresorcinol pills, manufactured by the Retort Pharmaceutical Co., Lot No. A-21895, was received and noted, and a copy of your attachments is appended for discussion. You will note that the one from the Retort Pharmaceutical Co. states that this product complies with USP requirements, but you will note that Frank H. Wiley, Chief, Department of Pharmaceutical Chemistry, states in his letter, addressed to Charles R. Wolfe, that the pills have a friable coating, and not a tough gelatin coating, as required by the USP. We feel that such tablets should not be shipped into this tropical area. As you know, we have a warehouse full of these hexylresorcinol tablets that happen to be deteriorating, and may be injurious to the mouth of patients when dispensed. The dispensing of these tablets has been held up because the Vietnamese, Cambodians, and Laotians lack the laboratory facilities and technicians to diagnose ascariasis. Would you describe that condition, Doctor? Dr. ROBBINS. Round worms. The worm is about 6 to 8 inches long-the adult type. Mr. BROWNSON (reading): Therefore, even though we have 2,000 first-aid kits dispensed in Vietnam (none as yet in Cambodia and Laos) the tablets are not being used and remain in our warehouse. If there is any other area that could use these deteriorating hexylresorcinol tablets, we would be glad to have them taken off our hands, as soon as possible. In the meantime, we are trying to establish laboratory centers where diagnosis can be made, in the hope that use will be made of these inferior tablets. This is for your information, and any suggestions you may have. Yours very truly, It is signed "John R. Raffety, M. D., Chief, Public Health Division, STEM." Do you concur, Doctor, in Dr. Raffety's opinion regarding the necessity for a diagnosis before dispensing these pills? Dr. ROBBINS. No; I don't in the particular use that we were going to make of them. A worm that is 6 to 8 inches long does not need a microscope to detect it, and while it is true you can tell more accurately if a person has round worms if you see them under the microscope, and can see the ova or eggs, still, these first-aiders are living with the villagers, and they are talking to them constantly; they are close, and I am sure that the few worms that are passed would be a tipoff to the villager and the first-aider that the person had worms. So, we were not trying to depend upon complicated diagnostic facilities. In our 7 months' discussion of this matter, this came up a great number of times about whether the village first-aider could administer hexylresorcinol with safety and effectively, and our conclusion, after 7 months, following the Bangkok conference where we presented it, was that we felt that it was a good thing to do. Mr. BROWNSON. You almost had to arrive at that conclusion to justify ordering 1.5 million vials of those pills? Dr. ROBBINS. That is right. Mr. BROWNSON. In other words, you think it had to be a mass impact program. It could not have been an individual diagnostic program or the quantity would have been way out of line? Dr. ROBBINS. That is right. Mr. BROWNSON. I have an airgram from the mission in Saigon to FOA, Washington, dated April 7, 1954. It clears up some of the dates that we have mentioned, and states as follows: 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, N. Y. There is considerable information in the files of FOA, Washington, concerning tests of samples of this drug made by the Food and Drug Administration, New York Laboratory, reference Mr. Hingher's letter dated July 15, 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 and they discuss the first contract. Contract GS-OOP-16154-PR95-370-00-H201-2229, arrived July 22, 1952. This entire lot is unsatisfactory because of the fact that the coating has cracked and has disintegrated. There are on hand 1,073,119 vials of 5 tablets each. On the second lot (reading): Contract GS-OOP-16436-PR95-370-00-202–2273, 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 degree of safety. However, it will have to be closely supervised when used for children. On hand, 697,180 vials of 5 tablets each. Contract No. GS-OOP-16436-PR95-370-00-2273, arrived October 4, 1952. Again, the coating on this lot is brittle, but is holding together. It can be used for adults, but must be closely supervised when used for treating children. On hand, 702,814 vials of 5 tablets each. Discovered by J. O. Raffety, G. F., pilot lieutenant. I would like to put the original in as exhibit 25 in the record at this point. (Exhibit 25 is as follows:) |