Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

  • United States. Congress. Senate. Committee on Government Operations.
Date:
1963
Catalogue details

Licence: Public Domain Mark

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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    figure for average lowering of the blood cholesterol as measured, and if this is indeed accounted for by the appearance of a new sterol, 24—-dehydro- cholesterol or desmosterol, then we need to think, as many have suggested, whether this is “good” or *‘bad,” clinically speaking, What are the atherogenic properties of these new sterols which may appear in the blood? Thus, Mr. Chairman, I think that the morning session by the clinicians has served to emphasize what we don’t know. I don’t know that the afternoon session is going to answer all these questions, but at least we have the stimulus of knowing what the clinicians don’t know. If the afternoon’s discourse goes as the morning’s has, I think that all of us will have plenty of work still to do, whether in the chemical laboratory, in the electrocardiographic laboratory, or merely in the out-patient department. Thank you. The Chairman: Thank you very much, indeed. I think that was a very fine, constructive and questioning summary. It emphasizes the statement of the late Dr. Eugene Dubois, that the evaluation of a drug in clinical medicine is an extremely difficult process, usually much more difficult than the experiments that the physiologists and chemists carry out in their laboratories. The final decision may involve hundreds of thousands or even millions of human beings; therefore, it is a major responsibility and cannot be taken lightly. In order to meditate about this, we will now adjourn. & ss * % u % % SUMMARY OF CLINICAL SECTION II By Irvine H. Page I am sure you do not want me to review what you have already heard this afternoon. You’ve heard a great deal of interesting work, in case you are in any doubt. I think you all recognize that, in many cases, intellectual bias is showing through the investigator’s bloomers, and that this is natural in a field that is so rapidly changing. I should say that the entire symposium was about “par for the course,” for meetings on atherosclerosis because the great need for re-evaluation of methods of study becomes so apparent. I think it is clear, for instance, from all the various studies that great con- fusion arises from incompletely evaluated methodology, as Dr. Gould pointed out. The methods for cholesterol determination have been notoriously erratic. We found this out by bitter experience in a so-called coordinated study of cholesterol and lipoproteins measured with the ultra-centrifuge. Even in laboratories that prided themselves on their ability to determine cholesterol, many of the measurements were grossly in error; it wasn’t enough merely to determine duplicates. What happened was that, from time to time, errors occurred with even reliable technicians. It was not until we were forced to send the cholesterols to Washington that it became apparent how -many mistakes could occur. Each one of us naturally defended our own laboratories, and this did nothing to clarify the issue. So I would strongly urge you to be as objective as possible with your own laboratory; do not warn your technicians that controls are going to be run. Simply put unknowns in the hopper and over a period of weeks and months find out to your chagrin the error of your ways. I think that any figure less than 5 percent. is suspicious, because the methods over a long period simply aren’t more reliable than that, nor is the human being that reliable. Another thing that has become increasingly apparent is that you cannot lump all people together according to the variability of their cholesterols. Most people, who have had enough experience, would agree that there are some so- called normal people who have wide swings in their cholesterols, others who exhibit extraordinary stability. What is a control period for one person need