APPENDIX

(Additional materials submitted for the record)

(A) FEDERAL REGISTER, RULES AND REGULATIONS: METHADONE

1. Federal Register, Vol. 35, No. 113-Thursday, June 11, 1970, Proposed
Rule Making, Department of Health, Education, and Welfare, Food and
Drug Administration [21 CFR Part 130] New Drugs: Conditions for
Investigational Use of Methadone for Maintenance Programs for
Narcotic Addicts_

2. Federal Register, Vol. 35, No. 113-Thursday, June 11, 1970, Rules and
Regulations, Title 21-Food and Drugs, Chapter 1-Food and Drug
Administration, Department of Health, Education, and Welfare, Sub-
chapter A-General, Part 3-Statements of General Policy or Interpre-
tation, Use of Methadone in the Maintenance Treatment of Narcotic
Addicts.

3. Federal Register, Vol. 35, No. 144-Saturday, July 25, 1970, Proposed
Rule Making, Department of Health, Education, and Welfare, Food and
Drug Administration [21 CFR Part 130] Methadone, Conditions for
Investigational Use for Maintenance Programs for Narcotic Addicts;
Extension of Time for Filing Comments_

4. Federal Register, Vol. 35, No. 158-Friday, August 14, 1970 [21 CFR
Part 130] Methadone, Conditions for Investigational Use for Mainte-
nance Programs for Narcotic Addicts; Extension of Time for Filing
Comments..

5. Federal Register, Vol. 35, No. 223-Tuesday, November 17, 1970,
Notices, Department of Justice, Bureau of Narcotics and Dangerous
Drugs, S. B. Penick and Co., Application for License to Manufacture
Methadone..

6. Federal Register, Vol. 36, No. 64-Friday, April 2, 1971, Rules and
Regulations, Part 130-New Drugs, Conditions for Investigational Use
of Methadone for Maintenance Programs for Narcotic Addicts.
7. Federal Register, Vol. 37, No. 67-Thursday, April 6, 1972, Proposed
Rule Making [21 CFR Part 130] Methadone, Proposed Special Require-
ments for Use...

8. Federal Register, Vol. 37, No. 78-Friday, April 21, 1972, Proposed Rule
Making, Department of Health, Education, and Welfare, Food and Drug
Administration [21 CFR Part 130] Methadone, Proposed Special
Requirements for Use; Correction

9. Federal Register, Vol. 37, No. 242-Friday, December 15, 1972, Rules
and Regulations, Title 21-Food and Drugs, Chapter 1, Food and Drug
Administration, Department of Health, Education, and Welfare, Sub-
chapter C-Drugs, Part 130-New Drugs, Approved New Drugs
Requiring Continuation of Long-Term Studies, Records, and Reports;
Listing of Methadone With Special Requirements for Use-
10. Federal Register, Vol. 37, No. 242-Friday, December 15, 1972, Notices,
Department of Health, Education, and Welfare, Food and Drug Admin-
istration [Docket No. FDC-D-575], Methadone, Proposed Withdrawal
of New Drug Applications; Notice of Opportunity for Hearing---.
11. Federal Register, Vol. 38, No. 50-Thursday, March 15, 1973, Notices,
Department of Health, Education, and Welfare, Food and Drug Admin-
istration, Methadone Notice of Interim Approval....

12. Federal Register, Vol. 38, No. 90-Thursday, May 10, 1973, Rules and
Regulations, Title 21-Food and Drugs, Chapter 1-Food and Drug
Administration, Department of Health, Education, and Welfare, Sub-
chapter C-Drugs, Part 130-New Drugs, Listing of Methadone With
Special Requirements for Use...

13. Federal Register, Vol. 38, No. 92-Monday, May 14, 1973, Notices, Methadone, Notice of Extension of Interim Approval.

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(B) SUPPLEMENTAL STATEMENTS, ARTICLES, CORRESPONDENCE, EXCERPTS, AND REPORTS PERTAINING TO THE USE AND ABUSE OF METHADONE

1. Letter with enclosures to Hon. Birch Bayh from Joseph A. Oddis, Execu-
tive Director, American Society of Hospital Pharmacists, April 17, 1973,
regarding the Society's comments and suggestions concerning S. 1115..
2. Letter with enclosures to Senator Birch Bayh, from Robert G. Newman,
M.D., Assistant Commissioner, Addiction Programs, The City of New
York Health Services Administration, Department of Health, April 17,
1973, regarding the Programs' comments and suggestions concerning
S. 1115_.

3. Statement, "A Declining Heroin Addiction Epidemic," by Robert L.
DuPont, M.D., Narcotics Treatment Administration Administrator,
Department of Human Resources, Government of the District of Colum-
bia and Mark H. Greene, M.D., United States Public Health Services,
Center for Disease Control, Epidemic Intelligence Service, Atlanta,
Georgia
4. Excerpt, "Narcotic-Related Deaths,' Government of the District of
Columbia-Department of Human Resources, Office of the Chief Med-
idal Examiner, Annual Report 1972, pp. 17-21..
5. Statement, "Methadone and the Black Community," Hon. Charles B.
Rangel, Member of Congress from the 19th Congressional District, New
York, before the 5th National Conference on Methadone Treatment,
Sheraton-Park Hotel, Washington, D.C., Sunday, March 18, 1973....
6. Statement, "Methadone Maintenance, Why Continue Controls?" by
Richard Phillipson, M.D., acting Associate Director for Operations,
Division of Narcotic Addiction and Drug Abuse, National Institute of
Mental Health. Presented at 3d National Conference on Methadone,
New York, November 14-16, 1970..

7. Excerpt, "Diversion, Urinalysis and Program Abuse," L. Thomas Carroll,
Proceedings, Fourth National Conference on Methadone Treatment,
1972, p. 147.

8. Excerpt, "An Empirical Assessment of the Availability of Illicit Methadone," Carl D. Chambers and James A. Inciardi, Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 149

151..

9. Excerpt, "Problems of Controlling Methadone Diversion in an Outpatient Clinic," William H. Dobbs, M.D., and Christine Freeman, R.N., Proceedings, Fourth National Conference on Methadone Treatment, 1972, p. 153.

10. Excerpt, "Methadone on the Streets, As a Parameter of Efficacy,' William A. Bloom, M.D., E. Ward Sudderth, M.D., Lee Marcelo, Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 169-170..

11. Excerpt, "Methadone fo Kicking and for Kicks," John A. Newmeyer, George R. Gay, Roger Corn, and David Smith, Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 461-464----12. Excerpt, "Methadone and Medical Ethics," James F. Maddux, M.D., Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 265-267_ _

13. Excerpt, "The Private Physician in the Future of Methadone Treatment,' J. T. Payte, Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 263-264

14. Excerpt, "Some Psychological Aspects of Barbiturate and Amphetamine Use During Methadone Maintenance," William F. Wieland, M.D., Proceedings Fourth National Conference on Methadone Treatment, 1972, pp. 145-146___.

15. Excerpt, "Drug Abuse in a Methadone Maintenance Treatment Program," S. J. Mule and E. J. Saffer, Proceedings, Fourth National Conference on Methadone Treatment, 1972, pp. 473-474..

16. Excerpt, "The Negative Effect of Police Intervention on a Methadone Treatment Program," Alan Fisch, M.D., Vernon D. Patch, M.D., and Anthony E. Raynes, M.D., Proceedings, Fourth National Conference on Methadone Maintenance, 1972, pp. 475-477...

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17. Excerpt, "Statement by the Black Caucus," by Dick Freeman, Proceedings, Fourth National Conference on Methadone Treatment, 1972, p. 553

852

18. Excerpt, "Statement by the Chicano Caucus," Chale Con La Carga, Proceedings, Fourth National Conference on Methadone Maintenance, 1972, p. 555.

19. Excerpt, "Statement by the Radical Caucus," Proceedings, Fourth National Conference on Methadone Treatment, p. 557.

20. Excerpt from the Second Report of the National Commission on Marihuana and Drug Abuse, "Drug Use in America: Problem in Perspective," 1973, pp. 176-181

21. Article, "The Vitality of Mythical Numbers," by Max Singer, The Public Interest, pp. 3-9

22. Article, "Methadone: best hope for now," by Amitai Etzioni, Smithsonian, April 1973, pp. 50, 52–53..

23. Article, "The Cure Becomes a New Problem," by Henry L. Lennard, Leon J. Epstein and Mitchell S. Rosenthal, Smithsonian, April 1973, pp. 51, 54-57..

24. Article, "Methadone_Maintenance: Trick or Treatment?" By Sidney Cohen, M.D., Human Behavior, Vol. 2, No. 1, January 1973, pp. 22-25 25. Article, "Narcotic Withdrawal Syndrome of the Neonate: Comparison of Treatment by Chloropromazine and Diazepam," by Charles H. Bauer, M.D., Adolescent Drug Abuse, Pediatric Annals, February, 1973, pp. 43-47

26. Article, “Babies Born Addicted to Methadone," by Stuart Auerbach,
The Washington Post, February 26, 1972---

27. Article, letter to the editor, "Methadone Babies," by Miryam Davis,
M.D., Pediatric Neurologist Consultant, Narcotics Treatment Ad-
ministration, Wash., D.C., The Washington Post, March 2, 1972-
28. Article, "The Youngest Addicts," Medicine section, Time, January
22, 1973, pp. 64-65---

29. Article, "A Second Generation of Junkies?" By Jacqueline Trescott,
The Evening Star, March 4, 1973.......

30. Bulletin, "Diagnosis and Treatment of Poisoning with Methadone," by
Vincent P. Dole, Frances F. Foldes, Harold Trigg, J. Waymond Robin-
son, and Saul Blatman, National Clearinghouse for Poison Control Cen-
ters, U.S. Department of Health, Education, and Welfare, Public Health
Service, Food and Drug Administration, Bulletin, March-April 1971---
31. Article, "Special problems of government-controlled methadone main-
tenance programs," by Robert G. Newman, M.D., Contemporary Drug
Problems, a Law Quarterly, Spring 1972, pp. 183-190..

32. Article, "Addicts and Methadone: a Dilemma," by Dr. Paul Cushman,
Jr., The Wall Street Journal, January 10, 1973.
33. Article, "Curse or Cure?" by Ida Walters, The Wall Street Journal,
July 27, 1972.

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34. Article, "Methadone: Will It Spread Addiction?" by August Gribbin,
The National Observer, May 27, 1972 (with enclosures) -
35. Letter to John Rector, Deputy Chief Counsel of the Subcommittee
from David A. Winston, Health Assistant, State of California, Health
and Welfare Agency, October 19, 1972.

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36. Statement of the National Research Council, National Academy of Sciences-National Academy of Engineering, Division of Medical Sciences, Committee on Problems of Drug Dependence, "Oral Methadone Maintenance Techniques in the Management of Morphine-Type Dependence"

37. Statement on Confidentiality by Dr. Jerome H. Jaffe, Director of the
Special Action Office for Drug Abuse Prevention Before the Subcom-
mittee on Alcoholism and Narcotics of the Senate Labor and Public Wel-
fare Committee, May 23, 1972.

38. Excerpt, "Confidentiality of patient records," Section 408 of Title IV,
Public Law 92-255, 92nd Congress, S. 2097, March 21, 1972, p. 14.
39. Federal Register, Vol. 37, No. 223-Friday, November 17, 1972,
Rules and Regulations, Title 21-Food and Drugs, Chapter III-
Special Action Office for Drug Abuse Prevention, Part 401-Confi-
dentiality of Drug Abuse Patient Records___

40. Opinion of State of New York Court of Appeals, "The People vs.
Robert Newman, M.D.," Unpublished, 1-No. 68-73-

41. Resource Guide of Heroin Treatment Articles, "Show Me Something
Better," Charlie Maclean, Office of Drug Abuse, Lansing, Mich.
42. Excerpt, "Don'ts for Your Methadone Maintenance Program," by
Sidney Cohen, M.D., Human Behavior, vol. 2, No. 1, Jan. 1973, pp.
22-25

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METHADONE USE AND ABUSE-1972

TUESDAY, NOVEMBER 14, 1972

U.S. SENATE,

COMMITTEE ON THE JUDICIARY

SUBCOMMITTEE TO INVESTIGATE JUVENILE DELINQUENCY

Los Angeles, Calif.

The subcommittee (composed of Senators Bayh, Hart, Burdick, Kennedy, Cook, Hruska, Fong and Mathias) met, pursuant to notice at 11:00 a.m., in room 8529, of the New Federal Building, 300 North Los Angeles Street, Hon. Birch Bayh (chairman) presiding.

Present: Senator Birch Bayh and Senator Roman Hruska.

Also present: Mathea Falco, staff director and chief counsel; John M. Rector, deputy chief counsel; Mary K. Jolly, editorial director and chief clerk; B. Elizabeth Marten; personal secretary to the staff director and chief counsel; Billy M. Wise, professional staff member; Malcolm Hawk, legislative assistant to Senator Hruska; Ronald Meredith, legislative assistant to Senator Cook; and Betty A. Webb, minority clerk.

Mr. BAYH. The hearing will come to order.

I think that I can speak for both my colleague and myself, when I say that we appreciate this welcome to "sunny" California which has been given the committee this morning. For those of you in the news media, I hope you put no relevance in the fact that Senator Hruska is situated somewhat to the right of Senator Bayh and the converse being true. I think that it is just an accident of the draw.

Mr. HRUSKA. It depends whether you are looking at it this way, or that way [indicating].

Mr. BAYH. Right. We can handle it any way we want to. [Laughter.] Perhaps the best way to deal with this is to resist the senatorial temptation of summarizing for 30 minutes what might be more appropriately dealt with in about 8 or 9 minutes to lay the foundation of our hearing this morning, and then my colleague can follow. We will get to the real reason for being here in California.

I have a prepared statement that I will read. Let me summarize by saying that our basic purpose for being here is to take advantage of the experience that the State of California has had in the treatment of heroin addiction and the application of methadone. I think it is fair to say that the State of California has had considerable experience. with methadone and has imposed a regulatory scheme stricter than most, if not all, the other States. I, for one, am anxious to learn what role methadone should play in a comprehensive approach to heroin addiction.