Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

459\\ e are basically saying, in order to solve this problem, notwithstandingthe reluctance of the agency heads who are appointed by the Executiveto put themselves in an embarrassing situation. However, the])roblem is of snch magnitude that somebody's feet have to be tothe fire and as the chairman said, let us give it to the Congress. If youtell us wdiat j^ou need and what you want, we will put our feet to thefire, so to speak, in an effort to come up Avith some viable solutions tothis problem.Thank 3'ou.Chairman Pepper. Mr. Steiger.Mr. Steiger. Yes, Mr. Chairman, thank you.Doctor, do you know of any drug that in your experience or to yourknowledge, was tested over a period in excess of 5 years on over 1,000people without receivmg some kind of a judgment as to its efl&cacy,safety, et cetera, that was within the purview of FDA and yourorganization?Dr. Brown. Not off the top of my head. I may say, although itmight not be what you are lookhig for in the way of an answer, severaldrugs oral antidiabetics used for as long as 10 years, that might notbe as effective as injectable ones, and there are many examples ofdrugs in use by tens of thousands of peoj^le where the real impact,its efficacy, did not become clear even though organized researchefforts were made toward it. In that sense I do not think methadonestands alone, you know, in terms of being used for tens of thousands ofpeople for over 5 years, without having the answers to questions ofeffectiveness. It is not that much a loner as perhaps you would imply.Mr. Steiger. Are you sayin.g that the oral diabetic drugs were inthis state of limbo for 10 years and used on thousands of people orwere approved and then 10 years later were found to be not as efficaciousas was originally thought to be?Dr. Brown. I am perhaps leading.Mr. Steiger. I see what you are saying.Dr. Brow N. Yes.Mr. Steiger. Mistakes have been m.ade as to the efficacy of drugs.Dr. Brown. Yes. There have been many drugs that have beenapproved as safe and efficacious with research over a 10-year period.Another example is that well-known one, the birth control pills,w^here the answers are still being sought as to their long-term impactwhen used over a period of 5 or 10 years.Mr. Steiger. But none of these failed to receive the FDA approvalover this period of time.Dr. Brown. As far as I know, they must have received the FDAapproval.Mr. Steiger. In your own mind now, we have got somewherebetween 20,000 and 30,000 people over a period of something in excessof 5 3"ears. We have been exposed to this. We have gone through theanimal i)rocesses and whatever else is required. Now you are talkingabout upping the ante to another 4,000 or 5,000.How many people are we going to have to try this on and for howlong before somebody is willing to say it is OK or it is not OK? Ifind it very difficult to accept your rationale up to now.Dr. Brown. The answer that I give to a question like that, and Ithink both your question and my answer are sincere in trying to cope