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The thrust of the bill is really to accomplish two purposes:
First, to provide for the regulation of bona fide treatment efforts to insure protection of the community and maximum benefits to the patients. That is one of the major classifications.
Second, to eliminate illegal or insincere efforts which are aimed merely at profiteering on the sale of the drug, and, of course, we have to get to a State and local level if we expect this Federal basis to work at all.
That is one of the purposes, of course, in asking the drug commissions of each State to develop a comprehensive plan and to go on from there.
Mr. KUSHNER. I think that LEAA has proven that this type of an attitude at the Federal level is successful in the reduction of crime rates, and we certainly are happy that the Federal government is taking this attitude in the area of drug abuse.
Senator HRUSKA: Reverend Bevins, do you have any contribution for the record?
Reverend BEVINS. I think two quick statements.
First of all, it is indicated that the new FDA regulations on methadone in terms of tightening some of the loopholes I think is a significant step in the right direction, and to support Mr. Kushner's testimony, we feel that this bill, which apparently gives the legal enforcement of those regulations, is a step in the right direction.
I would like to raise an issue that was a part of his testimony, and that is the issue of the Federal government also taking a look at other modalities for the treatment of narcotic addiction. We are finding, in terms of some of the people that we work with, some concern about methadone itself, and that methadone may be being viewed in some circles as the end-all or the cure-all for narcotics addiction, so we feel that there should be a continued exploration of other treatment modalities.
Senator HRUSKA. Your suggestion as to other modalities is well taken. I don't know whether there is any fix on methadone as the salvation or panacea. That is far from anybody's thought. We have to broaden the base. It is hoped that methadone will be just a harmonizing note or a note that will lead from one state of the art to another that will be more effective and perhaps a little easier to administer.
Do you have anything further, Mr. Kushner?
Mr. KUSHNER. No. We would just like to thank you for this opportunity, and if we can help you in any way, please feel free to get in touch with us.
Senator HRUSKA. Thank you both for coming and contributing to the record.
[Mr. Kushner's prepared statement is as follows:]
PREPARED STATEment of Mr. JEFFREY KUSHNER, EXECUTIVE DIRECTOR,
NEBRASKA COMMISSION ON DRUGS
Mr. Chairman and members of the subcommittee, I would like to thank you on behalf of the Nebraska Commission on Drugs for the opportunity to appear before this Committee with regard to Senate Bill 3846, a bill to aid in regulating the use of narcotic drugs in the treatment of narcotic addiction.
Accompanying me is Rev. Rex Bevins of the Nebraska Commission on
The State of Nebraska is not much different than other states in regards to the expansion of the drug abuse problem in recent years. Perhaps; the problem hasn't peaked yet in Nebraska, as hopefully it has in many coastal states and perhaps the drugs abused in Nebraska differs than many other states, but the problem is just as real. I do not wish to bore you with statistics, but from the 1971 Activity Summary of the Nebraska State Patrol the following information is available.
"In 1967 there were 52 arrests, in 1968-232 arrests, in 1969-510 arrests, in 1970-911 arrests and in 1971-1,806 arrests. In the year between 1970 and 1971 there was almost a 100 increase in arrests made. The 1972 rate looks like it will not quite double the 1971 figure."
These figures indicate no peaking affect has yet come to Nebraska. The report goes on to say, "It is estimated that the total illicit value of drugs seized by law enforcement in Nebraska in 1971 amounts to over $3,500,000. The seizures reflect only a small percentage of illegal transactions involving controlled substance; but even with this minimal data, it is apparent that illicit drugs are an important area of criminality."
The federal government must not take States like Nebraska lightly. Although the number of arrests and hard core addict population may be less than other more heavily populated states, the drug abuse problem is here, it is bad, and is getting worse.
Concerning Senate Bill 3846, the Nebraska Commission on Drugs is certainly in favor of any legislation that will aid in stopping the diversion of methadone or other drugs used in chemotherapy provided it does not hamper treatment programs. We are not sure that there is not a duplication of effort concerning this bill and the new FDA regulations dated December 15, 1972. I have talked with Senator Bayh's office and still have no clear answer on this. The separate registration of practitioners who distribute drugs for treatment should not hamper rehabilitation efforts as long as the confidence of the patient is maintained.
We believe a program of methadone maintainance for the treatment of opiate dependents is favorable and the advantages of such a program outweigh the disadvantages, however, every effort should be made to correct the disadvantages, one of which is methadone diversion. We believe that methadone administered in a liquid form provided in a setting which truly encourages a crime-free, normal social existence, is a definite benefit to society. We do, however, favor programs where the ultimate objective is total abstinance.
We believe that methadone maintainance alone should not be overplayed. A well-rounded program of moral support, self-help approaches, group and individual psychotherapy, vocational counseling, etc., should be stressed as needed components of any program to rehabilitate the drug addict. A multi-modality program with a wide range of treatment services, a coordinated system approach with a methadone component if necessary, is what we believe to be the correct method. The federal government should also consider the wide range of services as a correct approach and fund accordingly. Methadone programs should not be anymore important or have any more of a priority than other treatment modalities. Just as drug services need to be coordinated at the local level, there needs to be coordination and planning at the state level and most of all coordination at the federal level. We encourage Dr. Jaffe's attempts to coordinate at the federal level so that NIMH knows what the Office of Education is doing; so that the Office of Education knows what the Bureau of Narcotics and Dangerous Drugs is doing, so that Bureau of Narcotics and Dangerous Drugs knows what the Food and Drug Administration is doing, etc. We have found even within a single agency one division is not aware of what the other is doing. We encourage the use of the Single State Agency for at least review and comment on all federal grant applications, to coordinate all drug efforts in the State. This can only happen through a sincere effort to coordinate a federal level.
The Nebraska Commission on Drugs encourages the efforts of the FDA, SEODAP, BNDD, NIMH, the Office of Drug Abuse Law Enforcement and LEAA in their efforts to provide new regulations to minimize methadone diversion without affecting the development of treatment programs.
In summary; I would like to say that we support S. 3846 to closely monitor and regulate the dispensing of methadone and similar drugs. I would urge that the federal government make a more careful analysis of the multi-modality programs in our country and not stress the methadone maintainance programs in their funding efforts. And lastly, we need more guidance in the coordination of federal agencies in order to continue to seek a coordinated effort at the State level.
I thank you on behalf of the Nebraska Commission on Drugs.
Senator HRUSKA. We will hear from Mr. Rex Higley, director of examining boards, Nebraska Department of Health.
Mr. Higley, have you submitted a statement to the committee?
Senator HRUSKA. It is quite lengthy. You can read it. It will be placed in the printed record in its full text.
Mr. HIGLEY. Yes, sir.
Senator HRUSKA. You can either read it or you can highlight it, whichever you wish.
Mr. HIGLEY. Senator, we will make every effort to conserve time and highlight it.
Senator HRUSKA. Very well. It has been gone over by staff and by the chairman, but I don't want to say that by reading it, I am an expert on the subject. It helps to follow the testimony if it is read in advance as my associates will agree.
You may go ahead in your own way.
STATEMENT OF REX C. HIGLEY, DIRECTOR, BUREAU OF EXAMINING BOARDS, NEBRASKA DEPARTMENT OF HEALTH, OMAHA, NEBR.
Mr. HIGLEY. Senator Hruska, thank you very much for giving me this opportunity to appear before you today and give testimony regarding the utilization of methadone as a modality of treatment for heroin addiction.
I would like to set the stage a little bit about the Bureau of Examining Boards. The bureau is the agency of State government responsible for the enforcement of that section of the Nebraska criminal code which provides the controls for possession, distribution, prescribing, and administering of controlled substances in the legal channels of distribution. The primary duties for the enforcement of this same section of the criminal code for Nebraska in the illegal channels of distribution on a State level rests with the Drug Control Division of the Nebraska State Patrol and all peace officers of this State. This Bureau of Examining Boards, with the Department of Health, also has the responsibility, incidentally, for the enforcement of the practice acts of 17 health-oriented professions and occupational health fields, including the profession of medicine and surgery.
In approximately April of 1970, this bureau, through the Governor's office signed an agreement with the U.S. Department of Justice, Bureau of Narcotics and Dangerous Drugs; which established a "Memorandum of Understanding" between the Federal and State agencies. Such a "Memorandum of Understanding," of course, did not confer upon that State agency any real authority for the en
forcement of Federal statute, but it did avoid duplicity of enforcement of Federal statutes and State statutes where there were common interests, and investigations under certain conditions were conducted in which the reporting from our agency goes to both Federal and State levels. Cooperative onsite inspections and investigations were provided for in this agreement, and therefore I bring it out in this hearing today because this cooperative onsite inspection has been true in the areas of methadone maintenance utilization.
I think this brief review of the authority of the bureau may be essential to giving some understanding to the testimony which I wish to place before you.
A great controversy has arisen regarding the use of methadone as a modality of treatment for heroin addiction. I am sure this committee has already heard a great amount of testimony, here and elsewhere, regarding this controversy. Therefore, as an administrator for a regulatory agency, I could best serve this committee by giving as much factual testimony pertaining to the utilization of methadone in Nebraska as is possible, but it is very difficult for me to not let some opinion or bias creep in regarding the utilization of this problem. I shall attempt to try to establish for this committee the background facts and current status of the regulation of existing programs existent in the State of Nebraska; and to reveal something about our judgment as to the quantities and the levels of the use and distribution of methadone in this state.
Nebraska does not have a pharmaceutical manufacturer of methadone. Dorsey Laboratories, which is this State's largest pharmaceutical manufacturer, does not utilize methadone in any of their manufacturing processes, to my knowledge. Therefore, area of wholesale distribution and retail distribution through the pharmacies is under the prescribed procedures of the physician.
We have determined, in preparation for this testimony, from the three major distributors of methadone in this State, that the amount distributed at the present time is rather minimal. This is especially true when you compare the amounts of methadone distributed as compared to other medicinal and medical analgesics such as Demorel or Meperidine.
Observation of the distribution levels, prescribed and dispensed quantities of methadone in legal channels of distribution, reveal that methadone is classified as an analgesic, in comparison to other drug substances, fourth or fifth down the list. In other words, it is not utilized as the primary analgesic in the area. The primary current use of methadone is, in our opinion, to ameliorate the withdrawal symptoms associated with heroin and morphine addiction. FDA, as recently as December 15, 1972, as has already been testified to, proposed regulations which would remove methadone, for the most part, from the legal channels for analgesic use and rescind totally its antitussive use.
Regulatory agencies use several methods to determine the levels of use and the prescribed amounts of any given controlled substance, including methadone. Some States have the triplicate prescription form, a method which permits these agencies to constantly survey the utilization and the prescribing of every controlled substance.
Our procedure in Nebraska has been: The routine inspections of all distribution levels. The review of purchases of all legitimate users. The survey and inspection of all treatment centers in cooperation with BNDD as an observer on onsite inspections. Jurisdictional considerations have precluded our inspecting Federal centers. Conducting investigations which have been referred to the agency by cooperating law enforcement agencies where there has been a lapover between the investigations they conduct in the illegal channel that overlap into the legal channel. The investigations of all apparent or alleged possible diversion by audit and recommendation for appropriate actions taken against the professionals or individuals who have been engaging in this activity. This includes record keeping.
Having followed such procedures as outlined, the Bureau of Examining Boards has determined the following to be rather resultant conclusions about the controlled substance, methadone:
The primary use of methadone in Nebraska currently is as a modality for treatment for heroin addiction.
The amounts being prescribed to be used as an analgesic are relatively low by comparison to other analgesics and its use as an antitussive is rapidly becoming non-existent.
Even though it would appear that methadone would be safe and effective under certain conditions, especially when used in well-managed programs, as one means of treating a certain percentage of heroin addicts; Senator Cook's Bill, SB 3846, amending certain portions of the Controlled Substances Act of 1970. is necessary legislation. Primarily, the inclusion of registration and the increase of provisions for control for all programs, including practitioners who engage in the treatment of addiction through the use of methadone, is needed. The discussion of methadone as a detoxifying or maintenance substance is long, and I will try to skip some of that because I am sure this will come out in other people's testimony.
One local authority has been quoted as saying: "To substitute one chemically addicting substance for another is morally wrong." Another has been quoted as stating:
This is an over-simplification and methadone certainly provides an opportunity for the individual who cannot live a drug-free life at certain times in his life and it allows the addict to do things that they could not do if they were still using heroin; such as finding a job, socializing, and staying out of trouble with the authorities of law enforcement.
Still other individuals contend that the addiction levels of the "street heroin" are not sufficient to provide removal symptoms to the degree that methadone, is a modality, would be required, and their statement is something to the effect that: "It is like a mild case of the flu."
The Bureau of Examining Boards' activities in the methadone programs have developed as a result of two factors:
1. The requirement under State Legislative Bill No. 326, that all persons legally possessing or distributing controlled substances must register with this bureau.
2. Certain responsibilities jointly understood as both Federal and State responsibilities under the "Memorandum of Understanding" with BNDD.
According to the records of our bureau, there are three methadone maintenance programs currently functioning in Nebraska.